Twenty percent human albumin solution fluid bolus administration therapy in patients after cardiac surgery-II: a multicentre randomised controlled trial.

PURPOSE: After cardiac surgery, fluid bolus therapy (FBT) with 20% human albumin may facilitate less fluid and vasopressor administration than FBT with crystalloids. We aimed to determine whether, after cardiac surgery, FBT with 20% albumin reduces the duration of vasopressor therapy compared with crystalloid FBT. METHODS: We conducted a multicentre, parallel-group, open-label, randomised clinical trial in six intensive care units (ICUs) involving cardiac surgery patients deemed to require FBT. We randomised 240 patients to receive up to 400 mL of 20% albumin/day as FBT, followed by 4% albumin for any subsequent FBT on that day, or to crystalloid FBT for at least the first 1000 mL, with use of crystalloid or 4% albumin FBT thereafter. The primary outcome was the cumulative duration of vasopressor therapy. Secondary outcomes included fluid balance. RESULTS: Of 480 randomised patients, 466 provided consent and contributed to the primary outcome (mean age 65 years; median EuroSCORE II 1.4). The cumulative median duration of vasopressor therapy was 7 (interquartile range [IQR] 0-19.6) hours with 20% albumin and 10.8 (IQR 0-22.8) hours with crystalloids (difference - 3.8 h, 95% confidence interval [CI] - 8 to 0.4; P = 0.08). Day one fluid balance was less with 20% albumin FBT (mean difference - 701 mL, 95% CI - 872 to - 530). CONCLUSIONS: In patients after cardiac surgery, when compared to a crystalloid-based FBT, 20% albumin FBT was associated with a reduced positive fluid balance but did not significantly reduce the duration of vasopressor therapy.

Study protocol and statistical analysis plan for the 20% Human Albumin Solution Fluid Bolus Administration Therapy in Patients after Cardiac Surgery-ll (HAS FLAIR-II) trial.

Background: Fluid bolus therapy with 20% albumin may shorten the duration of vasopressor therapy in patients after cardiac surgery. Objective: To describe the study protocol and statistical analysis plan for the 20% Human Albumin Solution Fluid Bolus Administration Therapy in Patients after Cardiac Surgery-II (HAS FLAIR-II) trial. Design, setting, participants and intervention: HAS FLAIR-II is a phase 2b, multicentre, parallel group, openlabel, randomised controlled trial that will be conducted at six Australian intensive care units. Patients requiring fluid bolus therapy after cardiac surgery will be randomly assigned in a 1:1 ratio to the intervention of fluid bolus therapy with 20% albumin or a comparator of fluid bolus therapy with a crystalloid solution. Main outcome measures: The primary outcome measure is the cumulative duration of vasopressor therapy. Secondary outcomes include vasopressor use, service utilisation, and mortality. All analyses will be conducted on an intention-to-treat basis. Results and conclusion: The study protocol and statistical analysis plan will guide the conduct and analysis of the HAS FLAIR-II trial, such that analytical and reporting biases are minimised. Trial registration: This trial has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN No. 12620000137998).

Severe acute maternal morbidity trends in Victoria, 2001-2017.

BACKGROUND: The incidence of severe acute maternal morbidity (SAMM) is one method of measuring the complexity of maternal health and monitoring maternal outcomes. Monitoring trends may provide a quantitative method for assessing health care at local, regional, or jurisdictional levels and identify issues for further investigation. AIMS: Identify temporal trends for SAMM event rates and maternal outcomes over 17 years in the state of Victoria, Australia. MATERIALS AND METHODS: All maternal public health service admissions were extracted from an administrative dataset from July 2000 to June 2017. SAMM-related diagnoses were defined by matching as closely as possible with published definitions. Outcomes included annual SAMM event rates, hospital survival, and hospital length of stay (LOS). Temporal trends were analysed using mixed-effects generalised linear models. RESULTS: There were 854 777 live births and 1.21 million pregnancy-related hospital admissions which included 34 008 SAMM events in 29 273 records and in 3.42% (95%CI = 3.39-3.46) of births. Most common were severe pre-eclampsia (0.87% of births), severe postpartum haemorrhage (0.59%), and sepsis (0.62%). SAMM-related admissions were associated with longer LOS and higher mortality risk (P < 0.001). Maternal mortality ratio remained unchanged at 8.6 fatalities per 100 000 births (P = 0.65). CONCLUSION: Over 17 years, there was a significant increase in birth rate and SAMM-related events in Victoria. Administrative data may provide a pragmatic approach for monitoring SAMM-related events in maternal health services.

Peripheral venoarterial extracorporeal membrane oxygenation for severe hyperlactataemia after cardiac surgery: a pilot study.

BACKGROUND: Severe hyperlactataemia in patients after cardiac surgery is associated with poor prognosis and implies possible splanchnic hypoperfusion. Peripheral venoarterial extracorporeal membrane oxygenation (splanchnic ECMO) may be more effective at reducing lactic acidosis for these patients. OBJECTIVE: To investigate whether splanchnic ECMO attenuates hyperlactataemia and liver enzyme release in these patients, despite them having a cardiac index > 2 L/min/m2 and a mixed venous oxygen saturation > 55%. DESIGN AND PARTICIPANTS: Retrospective matched case- control study of patients treated with splanchnic ECMO for hyperlactataemia. Seven patients who had had cardiac surgery were treated with splanchnic ECMO compared with seven matched control patients. RESULTS: We observed a mean decrease in lactate levels from 9.9 mmol/L (SD, 2.9 mmol/L) to 1.4 mmol/L (SD, 0.6 mmol/L) in patients receiving 48 hours of splanchnic ECMO, compared with a mean of 10.4 mmol/L (SD, 2.8 mmol/L) to 4.4 mmol/L (SD, 5 mmol/L) during 48 hours in control patients (P < 0.0001). Normalisation of lactate levels (to < 2 mmol/L) was achieved within a mean of 16.3 hours (SD, 14.6 hours) with splanchnic ECMO, compared with 38.3 hours (SD, 23.8 hours) in the control group (P = 0.029). The median increase in alanine aminotransferase level with splanchnic ECMO was 68% (range, -84% to 2015%) compared with 158% (range: 0%-6024%) (not significant) in control patients. CONCLUSION: In a selected cohort of patients who had had cardiac surgery with severe post-operative hyperlactataemia, despite an acceptable cardiac index and a mixed venous oxygen saturation, splanchnic ECMO appeared to reduce overall lactate levels and time to normalisation of lactataemia.

Plastic Blood Gas Syringes and Measurement Error in Central Venous Oxygen Saturations.

OBJECTIVES: Measurement of central venous oxygen (SvO2) levels remains an important method for the detection of circulatory shock. Plastic blood gas syringes have supplanted glass. These syringes are, however, permeable to atmospheric oxygen. Common sampling practices, including a delay between blood aspiration and analysis and continuous mixing of the sample, may promote equilibration of the blood sample with atmospheric oxygen and could result in over estimation of SvO2 levels. METHODS: Pulmonary artery or central venous catheter blood samples were taken from 21 critically ill patients. Two venous blood gas samples were collected simultaneously in plastic syringes. One sample was continuously mixed through a gentle rotation. The other sample was not mixed. Blood gas analyses were undertaken on both samples at baseline and at 5, 10, 15, and 20 min. RESULTS: Compared with baseline levels, the SvO2 increased significantly over time for both continuously mixed and nonmixed samples (P < 0.0001). The rate of the increase was 2-fold greater for continuously mixed samples (P < 0.0001). For continuously mixed samples, the SvO2 was 63% at baseline, 65% at 5 min, 70% at 10 min, 74% at 15 min, and 78% at 20 min. For the nonmixed samples, the levels were 63%, 64%, 66%, 68%, and 70%, respectively. CONCLUSIONS: This is the first report documenting that plastic blood gas syringes systematically overestimate SvO2 levels when there is a delay in analysis or continuous mixing of the sample. Overestimation of SvO2 levels may harm patients as circulatory shock may not be recognized and treated.