Effect of a person-centred goals-of-care form and clinical communication training on shared decision-making and outcomes in an acute hospital: a prospective longitudinal interventional study.

BACKGROUND: Patients with a life-limiting illness (LLI) requiring hospitalisation have a high likelihood of deterioration and 12-month mortality. To avoid non-aligned care, we need to understand our patients' goals and values. AIM: To describe the association between the implementation of a shared decision-making (SDM) programme and documentation of goals of care (GoC) for hospitalised patients with LLI. METHODS: A prospective longitudinal interventional study of patients admitted to acute general medicine wards in an Australian tertiary hospital over 5 years was conducted. A SDM programme with a new GoC form, communication training and clinical support was implemented. The primary outcome was the proportion of patients with a documented person-centred GoC discussion (PCD). Clinical outcomes included hospital utilisation and 90-day mortality. RESULTS: 1343 patients were included. The proportion of patients with PCDs increased from 0% to 35.4% (adjusted odds ratio (aOR), 2.38; 95% confidence interval (CI), 2.01-2.82; P < 0.001). During this time, median hospital length of stay decreased from 8 days (interquartile range (IQR), 4-14) to 6 days (IQR, 3-11) (adjusted estimate effect, -0.38; 95% CI, -0.64 to -0.11; P = 0.005) and rapid response team activation from 28% to 13% (aOR, 0.87; 95% CI, 0.78-0.97; P value = 0.01). Documented treatment preference of high-dependency unit care decreased from 39.7% to 24.4% (aOR, 0.81; 95% CI, 0.73-0.89; P value < 0.001), and ward-based care increased from 31.9% to 55.1% (aOR, 1.24; 95% CI, 1.14-1.36; P value < 0.001). CONCLUSION: The implementation of a SDM programme was associated with increased documentation of person-centred GoC, changed patient treatment preference to lower intensity care and reduced hospital utilisation.

A pilot feasibility randomised controlled trial of bone antiresorptive agents on bone turnover markers in critically ill women.

Critical illness is associated with increased bone turnover, loss of bone density, and increased risk of fragility fractures. The impact of bone antiresorptive agents in this population is not established. This trial examined the efficacy, feasibility, and safety of antiresorptive agents administered to critically ill women aged fifty years or greater. Women aged 50 years or greater admitted to an intensive care unit for at least 24 h were randomised to receive an antiresorptive agent (zoledronic acid or denosumab) or placebo, during critical illness and six months later (denosumab only). Bone turnover markers and bone mineral density (BMD) were monitored for 1 year. We studied 18 patients over 35 months before stopping the study due to the COVID-19 pandemic. Antiresorptive medications decreased the bone turnover marker type 1 cross-linked c-telopeptide (CTX) from day 0 to 28 by 43% (± 40%), compared to an increase of 26% (± 55%) observed with placebo (absolute difference - 69%, 95% CI - 127% to - 11%), p = 0.03). Mixed linear modelling revealed differences in the month after trial drug administration between the groups in serum CTX, alkaline phosphatase, parathyroid hormone, and phosphate. Change in BMD between antiresorptive and placebo groups was not statistically analysed due to small numbers. No serious adverse events were recorded. In critically ill women aged 50-years and over, antiresorptive agents suppressed bone resorption markers without serious adverse events. However, recruitment was slow. Further phase 2 trials examining the efficacy of these agents are warranted and should address barriers to enrolment.Trial registration: ACTRN12617000545369, registered 18th April 2017.

Effect of communication skills training on documentation of shared decision-making for patients with life-limiting illness: An observational study in an intensive care unit.

Objectives: This article aims to examine the association between a shared decision-making (SDM) clinical communication training program and documentation of SDM for patients with life-limiting illness (LLI) admitted to intensive care. Methods: This article used a prospective, longitudinal observational study in a tertiary intensive care unit (ICU). Outcomes included the proportion of patients with SDM documented on an institutional Goals of Care Form during hospital admission, as well as characteristics, outcomes, and factors associated with an SDM admission. Intervention: Clinical communication skills training (iValidate) and clinical support program are the intervention for this study. Results: A total of 325 patients with LLI were admitted to the ICU and included in the study. Overall, 184 (57%) had an SDM admission, with 79% of Goals of Care Form completed by an iValidate-trained doctor. Exposure to an iValidate-trained doctor was the strongest predictor of an ICU patient with LLI having an SDM admission (odds ratio: 22.72, 95% confidence interval: 11.91-43.54, p < 0.0001). A higher proportion of patients with an SDM admission selected high-dependency unit-level care (29% vs. 12%, p < 0.001) and ward-based care (36% vs. 5%, p < 0.0001), with no difference in the proportion of patients choosing intensive care or palliative care. The proportion of patients with no deterioration plan was higher in the non-SDM admission cohort (59% vs. 0%, p < 0.0001). Conclusions: Clinical communication training that explicitly teaches identification of patient values is associated with improved documentation of SDM for critically ill patients with LLI. Understanding the relationship between improved SDM and patient, family, and clinical outcomes requires appropriately designed high-quality trials randomised at the patient or cluster level.

Frailty is not independently associated with intensive care unit length of stay: An observational study.

BACKGROUND: Frailty is independently associated with morbidity and mortality in critically ill patients. However, the association between preadmission frailty and the degree of treatment received in the intensive care unit (ICU) remains unclear. OBJECTIVE: To describe patient length of stay in an ICU and the treatments provided according to the extent of patient frailty. METHODS: Single-centre retrospective cohort study of adult patients admitted to a tertiary ICU between January 2018 and December 2019. Frailty was assessed using the Clinical Frailty Scale (CFS). The primary outcome was ICU length of stay stratified by CFS score (1-8). Secondary outcomes were the proportion of patients with each CFS score treated with vasoactive agents, invasive ventilation, noninvasive ventilation, renal replacement therapy, and tracheostomy. Poisson regression and competing risks regression was used to analyse associations between ICU length of stay and potential confounders. RESULTS: The study cohort comprised 2743 patients, with CFS scores known for 2272 (83%). Length of stay in the ICU increased with each increment in the CFS up to a score of 5, beyond which it decreased with higher frailty scores. After adjusting for age, illness severity, admission type, and treatment limitation, CFS scores were not independently associated with length of stay in the ICU (P = 0.31). The proportion of patients receiving specific ICU treatments peaked at different CFS scores, being highest for vasoactive agents at CFS 5 (47%), invasive ventilation CFS 3 (51%), noninvasive ventilation CFS 6 (11%), renal replacement therapy CFS 6 (8.2%), and tracheostomy CFS 5 (2.2%). Increasing frailty was associated with increased mortality and discharge to a destination other than home. CONCLUSIONS: The extent of frailty is not independently associated with length of stay in the ICU. The proportion of patients receiving specific ICU treatments peaked at different CFS scores.

Documentation of neurological status in patients admitted to an intensive care unit after cardiac arrest: A 10-year cohort study.

OBJECTIVE: The objective of this study was to describe the documented neurological assessment and investigations for neuroprognostication in patients after cardiac arrest. DESIGN, SETTING, AND PARTICIPANTS: This was a retrospective cohort study of adult patients after cardiac arrest, admitted to a tertiary intensive care unit (ICU), between January 2009 and December 2018. MAIN OUTCOME MEASURES: The main outcome measures were the proportion of patients with a documented Glasgow Coma Scale (GCS) score and investigations for neuroprognostication. RESULTS: Four hundred twenty-seven patients formed the study cohort. The GCS score was documented for 267 (63%) patients at some time during their ICU stay. The proportion of patients with the GCS score documented decreased each day of ICU stay (59% at day 1, 20% at day 5). Pupil reflex to light was recorded in 352 (82%), corneal reflex in 155 (36%), and limb reflexes in 216 (51%) patients. Twenty-eight (6.6%) patients underwent brain magnetic resonance imaging, 10 (2.3%) an electroencephalogram, and two somatosensory evoked potentials. Withdrawal of life-sustaining treatments occurred in 166 (39%) patients, and 221 (52%) patients died in hospital. CONCLUSIONS: In this single-centre study of patients admitted to the ICU after cardiac arrest, the GCS score was inconsistently documented, and investigations for neuroprognostication were infrequent.

Estimation of Whole-Body and Appendicular Lean Mass from Spine and Hip Dual Energy X-ray Absorptiometry: A Cross-Sectional Study.

Whole-body dual X-ray absorptiometry (DXA) accurately measures lean mass but is not routinely used in clinical practice. Hip and spine DXA are used in the diagnosis of osteoporosis, and with the common co-occurrence of sarcopenia with osteoporosis, regional DXA scans provide an opportunity for assessment of lean mass. The aim of this study is to develop predictive equations for the estimation of whole-body lean mass (WBLM), appendicular lean mass (ALM) and whole-body fat mass (WBFM) from regional DXA scans. A total of 2427 participants (ages 20-96 year; 57.7% men) from the Geelong Osteoporosis Study who underwent both regional and whole-body DXA were included in the analysis. Using forward stepwise multivariable linear regression, percentage fat (spine%fat, hip%fat) values from lumbar spine and femoral neck DXA were used in combination with clinical data to develop and validate equations for the estimation of WBLM, WBFM and ALM. Mean age was 53.5 year (± 19.2), weight 78.2 kg (± 15.4), height 169.6 cm (± 9.4), WBLM 50.4 kg (± 11.1), ALM 22.8 kg (± 5.4) and WBFM 24.3 kg (± 10.4). Spine%fat (r = 0.21) and hip%fat (r = - 0.34) were correlated with whole-body lean mass (p < 0.001). Final predictive equations included age, sex, weight, height, spine%fat, and hip%fat and possessed high predictive value (Adj R2 0.91-0.94, RMSE 1.60-2.84 kg). K-fold cross-validation methods produced median root mean square error (RMSE) ranging from 1.59 to 2.81 kg for the three models. Regional DXA scans of the spine and hip can be used to estimate whole-body and appendicular lean mass, to assist in the identification of low muscle mass.

Long-term outcomes of patients admitted to an intensive care unit with intentional self-harm.

Self-harm is one of the most common reasons for admission to an intensive care unit (ICU). While most patients with self-harm survive the ICU admission, little is known about their outcomes after hospital discharge. We conducted a retrospective cohort study of patients in the Barwon region in Victoria admitted to the ICU with self-harm (between 1998 and 2018) who survived to hospital discharge. The primary objective was to determine mortality after hospital discharge, and secondarily estimate relative survival, years of potential life lost, cause of death and factors associated with death. Over the 20-year study period, there were 710 patients in the cohort. The median patient age was 37 years (interquartile range (IQR) 26-48 years). A total of 406 (57%) were female, and 527 (74%) had a prior psychiatric diagnosis. The incidence of ICU admission increased over time (incidence rate ratio 1.05; 95% confidence interval (CI) 1.03-1.06 per annum). There were 105 (15%) patients who died after hospital discharge. Relative survival decreased each year after discharge, with the greatest decrement during the first 12 months. At ten years, relative survival was 0.85 (95% CI 0.81-0.88). The median years of potential life lost was 35 (IQR 22-45). Cause of death was self-harm in 27%, possible self-harm in 32% and medical disease in 41%. The only factors associated with mortality were male sex, older age and re-admission to ICU with self-harm. Further population studies are required to confirm these findings, and to understand what interventions may improve long-term survival in this relatively young group of critically ill patients.

Values, preferences and goals identified during shared decision making between critically ill patients and their doctors.

Objective: Examine values, preferences and goals elicited by doctors following goals-of-care (GOC) discussions with critically ill patients who had life-limiting illnesses. Design: Descriptive qualitative study using four-stage latent content analysis. Setting: Tertiary intensive care unit (ICU) in South Western Victoria. Participants: Adults who had life-limiting illnesses and were admitted to the ICU with documented GOC, between October 2016 and July 2018. Intervention: The iValidate program, a shared decision-making clinical communication education and clinical support program, for all ICU registrars in August 2015. Main outcome measures: Matrix of themes and subthemes categorised into values, preferences and goals. Results: A total of 354 GOC forms were analysed from 218 patients who had life-limiting illnesses and were admitted to the ICU. In the categories of values, preferences and goals, four themes were identified: connectedness and relational autonomy, autonomy of decision maker, balancing quality and quantity of life, and physical comfort. The subthemes - relationships, sense of place, enjoyment of activities, independence, dignity, cognitive function, quality of life, longevity and physical comfort - provided a matrix of issues identified as important to patients. Relationship, place, independence and physical comfort statements were most frequently identified; longevity was least frequently identified. Conclusion: Our analysis of GOC discussions between medical staff and patients who had life-limiting illnesses and were admitted to the ICU, using a shared decision-making training and support program, revealed a framework of values, preferences and goals that could provide a structure to assist clinicians to engage in shared decision making.

Defining patient-centered recovery after critical illness - A qualitative study.

PURPOSE: To explore perspectives of adult critical illness survivors and identify important aspects to care and recovery. MATERIALS AND METHODS: A descriptive, qualitative study of adult survivors of prolonged critical illness, six-months after Intensive Care Unit (ICU) discharge, using semi-structured interviews and thematic analysis. The study was undertaken in an academic, tertiary, regional hospital in Victoria, Australia. RESULTS: Thirty-five patients participated in the study. Most were male (69%) with median age 64 years. Admissions were predominantly medical (51%), followed by cardiothoracic (26%) and general surgical (23%). Median ICU and hospital length of stay were 5 and 17 days respectively. Qualitative analysis revealed two key theme categories, recovery status and care experience. Three recovery states were identified based on physical and neuropsychological recovery. Care experiences varied across recovery states, including care encounters, communication, support and impact on family and friends, and use of community health services. CONCLUSION: Critical illness survivors frame their recovery in terms of recovery status and care experience, reflecting existing qualitative domains of physical health, psychological health, cognitive function, social health and life satisfaction. Theme content varied with recovery status, raising the possibility that modifying care experiences or patient perceptions could change recovery outcomes.

Osteoporosis and the Critically Ill Patient.

Improved survival after critical illness has led to recognition of impaired recovery following critical illness as a major public health problem. A consistent association between critical illness and accelerated bone loss has been described, including changes in bone turnover markers, bone mineral density, and fragility fracture rate. An association between accelerated bone turnover and increased mortality after critical illness is probable. Assessment of the effect of antifracture agents on fracture rate and mortality in the high-risk population of postmenopausal women with prolonged ventilation is warranted.

Effect of communication skills training on outcomes in critically ill patients with life-limiting illness referred for intensive care management: a before-and-after study.

OBJECTIVES: To describe the effect of a communication skills training programme on patient-centred goals of care documentation and clinical outcomes in critically ill patients with life-limiting illnesses (LLI) referred for intensive care management. METHODS: Prospective before-and-after cohort study in a tertiary teaching hospital in Australia. The population was 222 adult patients with LLI referred to the intensive care unit (ICU). The study was divided into two periods, before (1 May to 31 July 2015) and after (15 September to 15December 2015) the intervention. The intervention was a 2-day, small group, simulated-patient, communication skills course, and process of care for patients with LLI. The primary outcome was documentation of patient-centred goals of care discussion (PCD) within 48 hours of referral to the ICU. Secondary outcomes included clinical outcomes and 90-day mortality. RESULTS: The intervention was associated with increased documentation of a PCD from 50% to 69% (p=0.004) and 43% to 94% (p<0.0001) in patients deceased by day 90. A significant decrease in critical care as the choice of resuscitation goal (61% vs 42%, p=0.02) was observed. Although there was no decrease in admission to ICU, there was a significant decrease in medical emergency team call prevalence (87% vs 73%, p=0.009). The cancer and organ failure groups had a significant decrease in 90-day mortality (75% vs 44%, p=0.02; 42% vs 16%, p=0.01), and the frailty group had a significant decrease in 90-day readmissions (48% vs 19%, p=0.003). CONCLUSIONS: The intervention was associated with increased PCD documentation and decrease in the choice of critical care as the resuscitation goal. Admissions to ICU did not decrease, and although limited by study design, condition-specific trajectory changes, clinical interventions and outcomes warrant further study.

A prospective observational study of prevalence and outcomes of patients with Gold Standard Framework criteria in a tertiary regional Australian Hospital.

OBJECTIVES: Report the use of an objective tool, UK Gold Standards Framework (GSF) criteria, to describe the prevalence, recognition and outcomes of patients with palliative care needs in an Australian acute health setting. The rationale for this is to enable hospital doctors to identify patients who should have a patient-centred discussion about goals of care in hospital. DESIGN: Prospective, observational, cohort study. PARTICIPANTS: Adult in-patients during two separate 24 h periods. MAIN OUTCOME MEASURES: Prevalence of in-patients with GSF criteria, documentation of treatment limitations, hospital and 1 year survival, admission and discharge destination and multivariate regression analysis of factors associated with the presence of hospital treatment limitations and 1 year survival. RESULTS: Of 626 in-patients reviewed, 171 (27.3%) had at least one GSF criterion, with documentation of a treatment limitation discussion in 60 (30.5%) of those patients who had GSF criteria. Hospital mortality was 9.9%, 1 year mortality 50.3% and 3-year mortality 70.2% in patients with GSF criteria. One-year mortality was highest in patients with GSF cancer (73%), renal failure (67%) and heart failure (60%) criteria. Multivariate analysis revealed age, hospital length of stay and presence of the GSF chronic obstructive pulmonary disease criteria were independently associated with the likelihood of an in-hospital treatment limitation. Non-survivors at 3 years were more likely to have a GSF cancer (25% vs 6%, p=0.004), neurological (10% vs 3%, p=0.04), or frailty (45% vs 3%, p=0.04) criteria. After multivariate logistic regression GSF cancer criteria, renal failure criteria and the presence of two or more GSF clinical criteria were independently associated with increased risk of death at 3 years. Patients returning home to live reduced from 69% (preadmission) to 27% after discharge. CONCLUSIONS: The use of an objective clinical tool identifies a high prevalence of patients with palliative care needs in the acute tertiary Australian hospital setting, with a high 1 year mortality and poor return to independence in this population. The low rate of documentation of discussions about treatment limitations in this population suggests palliative care needs are not recognised and discussed in the majority of patients. TRIAL REGISTRATION NUMBER: 11/121.

Changes in bone mineral density in women before critical illness: a matched control nested cohort study.

The contribution of premorbid bone health to accelerated bone loss following critical illness is unknown. This study compared bone density in women before critical illness to women who did not become critically ill. Overall bone density was similar, although femoral neck bone mass increased immediately prior to critical illness. PURPOSE: The relative contribution of acute and chronic factors to accelerated loss of bone mineral density (BMD) following critical illness is unknown. This study compared the BMD trajectory of women before critical illness to the BMD trajectory of women who did not become critically ill. METHODS: This prospective, nested, age- and medication-matched, case-control study compared trajectory of BMD in women in the Geelong Osteoporosis study (GOS) requiring admission to an Australian Intensive Care Unit (ICU) between June 1998 and March 2016, to women not admitted to ICU. The main outcome was age and medication use adjusted change in BMD. RESULTS: A total of 52 women, with a mean age of 77 ± 9 years were admitted to ICU, predominantly post-surgery (75%), during the study period. A greater age-adjusted annual rate of decline was observed for pre-ICU women compared to no-ICU women for AP spine BMD (-0.010 ± 0.002 g/cm2 vs -0.005 ± 0.002 g/cm2, p = 0.01) over the 15-year study period. In participants with multiple BMDs 2 years before critical illness, a significantly greater increase in femoral neck BMD compared to age- and medication-matched controls was observed (difference in BMD, ICU vs no-ICU = 0.037 ± 0.013 g/cm2, p = 0.006). CONCLUSION: In a cohort of women with predominantly surgical ICU admission, bone health prior to critical illness was comparable to age- and medication-matched controls, with a relative increase in femoral neck bone mass immediately prior to critical illness. These findings suggest critical illness-related bone loss cannot be entirely explained as a continuation of pre-morbid bone trajectory.

The association of time and medications with changes in bone mineral density in the 2 years after critical illness.

BACKGROUND: Critical illness is associated with increased risk of fragility fracture and loss of bone mineral density (BMD), although the impact of medication exposures (bone anti-fracture therapy or glucocorticoids) and time remain unexplored. The objective of this study was to describe the association of time after ICU admission, and post-ICU administration of bone anti-fracture therapy or glucocorticoids after critical illness, with change in BMD. METHODS: In this prospective observational study, conducted in a tertiary hospital ICU, we studied adult patients requiring mechanical ventilation for at least 24 hours and measured BMD annually for 2 years after ICU discharge. We performed mixed linear modelling to describe the association of time, and post-ICU administration of anti-fracture therapy or glucocorticoids, with annualised change in BMD. RESULTS: Ninety-two participants with a mean age of 63 (±15) years had at least one BMD assessment after ICU discharge. In women, a greater loss of spine BMD occurred in the first year after critical illness (year 1: -1.1 ± 2.0% vs year 2: 3.0 ± 1.7%, p = 0.02), and anti-fracture therapy use was associated with reduced loss of BMD (femur 3.1 ± 2.4% vs -2.8 ± 1.7%, p = 0.04, spine 5.1 ± 2.5% vs -3.2 ± 1.8%, p = 0.01). In men anti-fracture and glucocorticoid use were not associated with change in BMD, and a greater decrease in BMD occurred in the second year after critical illness (year 1: -0.9 ± 2.1% vs year 2: -2.5 ± 2.1%, p = 0.03). CONCLUSIONS: In women a greater loss of spine BMD was observed in the first year after critical illness, and anti-fracture therapy use was associated with an increase in BMD. In men BMD loss increased in the second year after critical illness. Anti-fracture therapy may be an effective intervention to prevent bone loss in women after critical illness.

Service delivery model of extracorporeal membrane oxygenation in an Australian regional hospital.

BACKGROUND: The role of extracorporeal membrane oxygenation (ECMO) for adults in regional centres with low numbers of patients receiving ECMO is unclear. A robust service delivery model may assist in the quality provision of ECMO. OBJECTIVE: To describe a novel ECMO service delivery model in a regional Australian hospital, reporting on patient characteristics and outcomes before and after its implementation. METHODS: An observational cohort study of all patients receiving ECMO at the University Hospital Geelong intensive care unit before and after implementation of a new ECMO clinical service model. The program included intensivist training in cannulation and care for ECMO patients, nurse accreditation in ECMO maintenance, and establishing a relationship with an ECMO centre caring for a high number of patients. Data included ECMO caseload, circuit configuration, complications, durations of therapy, and survival to ECMO weaning and ICU and hospital discharge. RESULTS: During the 14-year period for which we collected data, 61 adults received ECMO: 21 (35%) before and 40 (65%) after implementation of the structured program. The median annual case rate increased significantly between periods from two (range, 0-5 cases) to 10 (range, 5-13 cases) (P < 0.01). Other changes from before to after implementation included more medical indications for ECMO (48% v 80%; P < 0.01), higher peripheral cannulation configuration (57% v 98%; P < 0.01) and greater intensivist involvement as cannulation proceduralists (29% v 80%; P < 0.01). There were no significant differences between cohorts in ECMO weaning or duration, complication rates or ICU or in-hospital mortality. CONCLUSIONS: Provision of ECMO in a tertiary regional hospital within a multifaceted clinical service model is feasible and safe. Partnership with a centre providing ECMO for a high number of patients during service development and delivery is desirable.

Prevalence, goals of care and long-term outcomes of patients with life-limiting illness referred to a tertiary ICU.

OBJECTIVE: To describe the prevalence, characteristics, long-term outcomes and goals-of-care discussions of patients with objective indicators of life-limiting illnesses (LLIs) referred to the intensive care unit. DESIGN, SETTING AND PATIENTS: A prospective, observational, cohort study of all adult inpatients referred to the ICU by the medical emergency team or by direct referral, during the period 30 August 2012 to 1 February 2013, at a tertiary teaching hospital in Australia. MAIN OUTCOME MEASURES: Mortality, LLIs, discharge destination and documentation on goals of care in medical record. RESULTS: A total of 649 of 1024 patients referred to the ICU had an LLI, and only 34.4% of these patients had goals of care documented. Overall, 49.2% were admitted to the ICU, 48.4% were discharged home, and the 1-year mortality was 35.1%. The most common LLI criteria were heart disease (52.2%), chronic obstructive pulmonary disease (24.8%) and frailty (23.7%). The highest 1-year mortality was associated with pre-hospital residence in a nursing home (64.9%), dementia (63.3%), cancer (60.8%) and frailty (50.6%). Analysis of patients by clinical trajectory showed that 1-year mortality was significantly higher for patients with cancer (59.6%), combined organ failure and frailty (47.3%), frailty (43.8%) and organ failure (23.6%), compared with patients with no LLI (P < 0.0001). CONCLUSIONS: A high proportion of patients referred to the ICU have an LLI, and this is associated with prolonged hospital length of stay and a high 1-year mortality, and only one-quarter have documented discussions on goals of care. Patients with cancer-related and frailty-related LLIs have the worst survival trajectories.

Changes in Bone Mineral Density in the Year after Critical Illness.

RATIONALE: Critical illness may be associated with increased bone turnover and loss of bone mineral density (BMD). Prospective evidence describing long-term changes in BMD after critical illness is needed to further define this relationship. OBJECTIVES: To measure the change in BMD and bone turnover markers (BTMs) in subjects 1 year after critical illness compared with population-based control subjects. METHODS: We studied adult patients admitted to a tertiary intensive care unit (ICU) who required mechanical ventilation for at least 24 hours. We measured clinical characteristics, BTMs, and BMD during admission and 1 year after ICU discharge. We compared change in BMD to age- and sex-matched control subjects from the Geelong Osteoporosis Study. MEASUREMENTS AND MAIN RESULTS: Sixty-six patients completed BMD testing. BMD decreased significantly in the year after critical illness at both femoral neck and anterior-posterior spine sites. The annual decrease was significantly greater in the ICU cohort compared with matched control subjects (anterior-posterior spine, -1.59%; 95% confidence interval, -2.18 to -1.01; P < 0.001; femoral neck, -1.20%; 95% confidence interval, -1.69 to -0.70; P < 0.001). There was a significant increase in 10-year fracture risk for major fractures (4.85 ± 5.25 vs. 5.50 ± 5.52; P < 0.001) and hip fractures (1.57 ± 2.40 vs. 1.79 ± 2.69; P = 0.001). The pattern of bone resorption markers was consistent with accelerated bone turnover. CONCLUSIONS: Critically ill individuals experience a significantly greater decrease in BMD in the year after admission compared with population-based control subjects. Their bone turnover biomarker pattern is consistent with an increased rate of bone loss.

Overview of the study protocols and statistical analysis plan for the Saline versus Plasma-Lyte 148 for Intravenous Fluid Therapy (SPLIT) research program.

BACKGROUND: 0.9% saline is the most commonly used intravenous (IV) fluid in the world but recent data raise the possibility that, compared with buffered crystalloid fluids such as Plasma-Lyte 148, the administration of 0.9% saline might increase the risk of developing acute kidney injury. OBJECTIVE: To provide an overview of the study protocols and statistical analysis plan for the six studies making up the (0.9% Saline v Plasma-Lyte 148 for Intravenous Fluid Therapy (SPLIT) research program. METHODS: The SPLIT study consists of six integrated clinical trials, including a double-blind, cluster, randomised, double-crossover study in intensive care unit patients, incorporating two nested studies within it; an open-label, before-and-after study in emergency department (ED) patients; a single-centre, double-blind, crossover trial in major surgical patients; and a randomised, double-blind study in ICU patients. All studies focus on biochemical and renal outcomes but will also provide preliminary data on patient-centred outcomes including inhospital mortality and requirements for dialysis. RESULTS AND CONCLUSION: The SPLIT study program will provide preliminary data on the comparative effectiveness of using 0.9% saline v Plasma-Lyte 148 for IV fluid therapy in ED, surgical and ICU patients.