1.
Intravenous albumin for the prevention of hemodynamic instability during sustained low-efficiency dialysis: a randomized controlled feasibility trial (The SAFER-SLED Study)
Clark EG, McIntyre L, Watpool I, Kong JWY, Ramsay T, Sabri E, Canney M, Hundemer GL, Brown PA, Sood MM, et al
Annals of intensive care. 2021;11(1):174
Abstract
BACKGROUND Hemodynamic instability is a frequent complication of sustained low-efficiency dialysis (SLED) treatments in the ICU. Intravenous hyperoncotic albumin may prevent hypotension and facilitate ultrafiltration. In this feasibility trial, we sought to determine if a future trial, powered to evaluate clinically relevant outcomes, is feasible. METHODS This single-center, blinded, placebo-controlled, randomized feasibility trial included patients with acute kidney injury who started SLED in the ICU. Patients were randomized to receive 25% albumin versus 0.9% saline (control) as 100 mL boluses at the start and midway through SLED, for up to 10 sessions. The recruitment rate and other feasibility outcomes were determined. Secondary exploratory outcomes included ultrafiltration volumes and metrics of hemodynamic instability. RESULTS Sixty patients (271 SLED sessions) were recruited over 10 months. Age and severity of illness were similar between study groups. Most had septic shock and required vasopressor support at baseline. Protocol adherence occurred for 244 sessions (90%); no patients were lost to follow-up; no study-related adverse events were observed; open label albumin use was 9% and 15% in the albumin and saline arms, respectively. Ultrafiltration volumes were not significantly different. Compared to the saline group, the albumin group experienced less hemodynamic instability across all definitions assessed including a smaller absolute decrease in systolic blood pressure (mean difference 10.0 mmHg, 95% confidence interval 5.2-14.8); however, there were significant baseline differences in the groups with respect to vasopressor use prior to SLED sessions (80% vs 61% for albumin and saline groups, respectively). CONCLUSIONS The efficacy of using hyperoncotic albumin to prevent hemodynamic instability in critically ill patients receiving SLED remains unclear. A larger trial to evaluate its impact in this setting, including evaluating clinically relevant outcomes, is feasible. Trial registration ClinicalTrials.gov (NCT03665311); First Posted: Sept 11th, 2018. https://clinicaltrials.gov/ct2/show/NCT03665311?term=NCT03665311&draw=2&rank=1.
2.
Effect of fresh red blood cell transfusions on clinical outcomes in premature, very low-birth-weight infants: the ARIPI randomized trial
Fergusson DA, Hébert P, Hogan DL, LeBel L, Rouvinez-Bouali N, Smyth JA, Sankaran K, Tinmouth A, Blajchman MA, Kovacs L, et al
JAMA: the Journal of the American Medical Association. 2012;308((14):):1443-51.
Abstract
CONTEXT Even though red blood cells (RBCs) are lifesaving in neonatal intensivecare, transfusing older RBCs may result in higher rates of organ dysfunction,nosocomial infection, and length of hospital stay. OBJECTIVE To determine if RBCs stored for 7 days or less compared with usual standards decreased rates ofmajor nosocomial infection and organ dysfunction in neonatal intensive care unitpatients requiring at least 1 RBC transfusion. DESIGN, SETTING, AND PARTICIPANTS Double-blind, randomized controlled trial in 377 premature infants with birthweights less than 1250 g admitted to 6 Canadian tertiary neonatal intensive careunits between May 2006 and June 2011. INTERVENTION Patients were randomlyassigned to receive transfusion of RBCs stored 7 days or less (n = 188) vsstandard-issue RBCs in accordance with standard blood bank practice (n = 189). MAIN OUTCOME MEASURES The primary outcome was a composite measure of majorneonatal morbidities, including necrotizing enterocolitis, retinopathy ofprematurity, bronchopulmonary dysplasia, and intraventricular hemorrhage, as wellas death. The primary outcome was measured within the entire period of neonatalintensive care unit stay up to 90 days after randomization. The rate ofnosocomial infection was a secondary outcome. RESULTS The mean age of transfusedblood was 5.1 (SD, 2.0) days in the fresh RBC group and 14.6 (SD, 8.3) days inthe standard group. Among neonates in the fresh RBC group, 99 (52.7%) had theprimary outcome compared with 100 (52.9%) in the standard RBC group (relativerisk, 1.00; 95% CI, 0.82-1.21). The rate of clinically suspected infection in thefresh RBC group was 77.7% (n = 146) compared with 77.2% (n = 146) in the standardRBC group (relative risk, 1.01; 95% CI, 0.90-1.12), and the rate of positivecultures was 67.5% (n = 127) in the fresh RBC group compared with 64.0% (n = 121)in the standard RBC group (relative risk, 1.06; 95% CI, 0.91-1.22). CONCLUSION In this trial, the use of fresh RBCs compared with standard blood bank practicedid not improve outcomes in premature, very low-birth-weight infants requiring atransfusion. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00326924;Current Controlled Trials Identifier: ISRCTN65939658.