Protocol for a prospective cohort study on the use of clinical nutrition and assessment of long-term clinical and functional outcomes in critically ill adult patients.

BACKGROUND AND AIMS: Limited data are available on the impact of clinical nutrition over the course of critical illness and post-discharge outcomes. The present study aims to characterize the use of nutrition support in patients admitted to European intensive care units (ICUs), and its impact on clinical outcomes. Here we present the procedures of data collection and evaluation. METHODS: Around 100 medical, surgical, or trauma ICUs in 11 countries (Austria, Belgium, Czech Republic, Germany, France, Hungary, Italy, Poland, Spain, Sweden, United Kingdom) participate in the study. In defined months between November 2019 and April 2020, approximately 1250 patients are enrolled if staying in ICU for at least five consecutive days. Data from ICU day 1-4 are collected retrospectively, followed by a prospective observation period from day 5-90 after ICU admission. Data collection includes patient characteristics, nutrition parameters, complications, ICU and hospital length of stay, discharge status, and functional outcomes. For data analysis, the target is 1000 patients with complete data. Statistical analyses will be descriptive, with multivariate analyses adjusted for potential confounders to explore associations between nutritional balance and change in functional status, time-to-weaning from invasive mechanical ventilation, time to first clinical complication, and overall 15, 30 and 90-day survival. ETHICS AND DISSEMINATION: This non-interventional study was reviewed and approved by the ethics committee of the Medical University Vienna, Vienna, Austria (approval number 1678/2019), and the respective ethical committees from participating sites at country and/or local level, as required. Results will be shared with investigators on a country level, and a publication and results presentation at the 2021 ESPEN Congress is planned. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT04143503.

Association between standard laboratory and functional tests of coagulation in dilutional coagulopathy: an in vitro study.

Standard laboratory tests (SLTs) of coagulation are in common use in clinical practice. We aimed to determine the association between SLTs and functional tests of coagulation in blood samples diluted with balanced crystalloid and colloid solutions in an ex vivo setting. The study group comprised 32 healthy young male volunteers. Whole blood samples were diluted at a 4:1 ratio with balanced crystalloid (Plasmalyte®) and two balanced colloids, 6% hydroxyethyl starch 130/0.4 (Volulyte®) and succinylated gelatin (Geloplasma®). SLTs included aPTT (activated partial thromboplastin time), PT (prothrombin time), fibrinogen concentration (FIB), D-dimers and number of platelets (PLT). Platelet aggregation was determined using multiple electrode aggregometry (MEA) with TRAP (thrombin receptor activating protein-6) as an assay activator. Coagulation and fibrinolysis were assessed functionally using rotational thromboelastometry (ROTEM). We found correlation between aPTT and INTEM (i.e. intrinsic coagulation pathway screening test) clotting time (R = 0.38 to 0.77; P < 0.05) for both undiluted and diluted samples. FIB and PLT were shown to be correlated with alpha angle in both INTEM and EXTEM (i.e. extrinsic coagulation pathway screening test) (FIB: R = 0.38 to 0.69; P < 0.05; PLT: 0.41 to 0.56; P < 0.05) again for both undiluted and diluted samples. FIB and PLT were associated with clot formation time in both INTEM and EXTEM (FIB: R = -0.44 to -0.70; P < 0.05; PLT: -0.36 to -0.58; P < 0.05). MEA results shown no correlation with ROTEM findings. There was also no correlation between number of platelets and their function as determined by MEA. Fibrinogen concentration correlated positively with fibrinogen function as determined by FIBTEM (i.e. fibrinogen deficiency/dysfunction screening test) maximum clot firmness (R = 0.49 to 0.73; P < 0.05). ROTEM results were predominantly associated with fibrinogen concentration and number of platelets. When there is no access to functional tests, concentration of fibrinogen is the most reliable test of coagulation, also in the context of fluid-induced coagulopathy.

Blood pressure variability in children with essential hypertension.

The aim of this study was to assess blood pressure variability (BPV) and its determinants in untreated hypertensive children. The study group consisted of 124 children, 91 boys and 33 girls, aged 14.9+/-2.5 with essential hypertension and no use of antihypertensive drugs. The subjects underwent routine examination, blood tests and ambulatory blood pressure (BP) monitoring. BPV was defined as the value of the standard deviation of BP for day- and night time periods. Daytime BPV was higher than night time BPV, and systolic BPV was higher than diastolic BPV. Significant positive correlations between 24-h, day- and night time systolic blood pressure (SBP), but not for diastolic blood pressure (DBP), and BPV were observed. In univariate analysis, day- and night time systolic BPVs were correlated with fasting glucose (r=0.609, P=0.02 and r=0.439, P=0.04); daytime systolic BPV, daytime diastolic BPV and night time systolic BPV were correlated with birth length (r=0.428, P=0.04; r=0.426, P=0.04 and r=0.439, P=0.04, respectively), and night time systolic BPV and night time diastolic BPV were correlated with age (r=0.604, P=0.02 and r=0.833, P=0.0001). However, in multiple linear regression analysis, daytime diastolic BPV was determined only by gender and systolic 24-h BP; night time systolic BPV depended on age, daytime SBP and DBP values, and daytime SBP and DBPs were determinants of night time diastolic BPV. The results highlighted the complex nature of BPV, with favourable role of host factors in its aetiology. The determinants of BPV in children are consistent with those in adults. Relationships between BPV and its determinants in untreated hypertensive subjects ought to be investigated in further researches.