Background Critically ill patients frequently develop acute kidney injury that necessitates renal replacement therapy (RRT). At some centers, critically ill patients who are hemodynamically unstable and require RRT are treated with slow low-efficiency dialysis (SLED). Unfortunately, hypotension is a frequent complication that occurs during SLED treatments and may limit the recovery of kidney function. Hypotension may also limit the amount of fluid that can be removed by ultrafiltration with SLED. Fluid overload can be exacerbated as a consequence, and fluid overload is associated with increased mortality. Occasionally, intravenous albumin fluid is given to prevent or treat low blood pressure during SLED. The intent of doing so is to increase the colloid oncotic pressure in the circulation to draw in extravascular fluid, increase the blood pressure, and enable more aggressive fluid removal with ultrafiltration. Nonetheless, there is little evidence to support this practice and theoretical reasons why it may not be especially effective at augmenting fluid removal in critically ill patients. At the same time, albumin fluid is expensive. As such, we present a protocol for a study to assess the feasibility of a randomized controlled trial evaluating the use of albumin fluid versus saline in critically ill patients receiving SLED. Methods This study is a single-center, double-blind, and randomized controlled pilot trial with two parallel arms. It involves randomly assigning patients receiving SLED treatment in the ICU to receive either albumin (25%) boluses or normal saline fluid boluses (placebo) to prevent and treat low blood pressure. Discussion The results of this pilot trial will help with planning a larger trial comparing the efficacy of the interventions in achieving fluid removal in critically ill patients with AKI on SLED. They will establish whether enough participants would participate in a larger study and accept the study procedures. Trial registration This trial is registered on ClinicalTrials.gov Identifier NCT03665311 , registered on September 11, 2018. Electronic supplementary material The online version of this article (10.1186/s40814-019-0460-3) contains supplementary material, which is available to authorized users.
summaryThe effect of the addition of lignocaine or saline to etomidate was studied in a randomised, double-blind trial involving 98 patients attending for day case surgery under general anaesthesia. The incidence of pain on injection of etomidate was signijTcantly reduced by the addition of lignocaine in a strength of I mglrnl.
Background: The safety and efficacy of low-molecular-weight heparin in the prevention of extracorporeal dialysis circuit clotting among in-center extended duration nocturnal hemodialysis (INHD) patients are unknown. The aim of this study was to determine the safety and efficacy of 2 doses of tinzaparin, among INHD patients receiving 6–8 h hemodialysis, 3 times per week. Methods: We conducted a retrospective cohort study to examine antifactor Xa levels at time 0, 2 h, 4 h mid-hemodialysis (mid-HD), 6 h, and at end of each INHD session for 4 weeks and to determine extracorporeal dialysis circuit clotting and bleeding events after switching from unfractionated heparin to tinzaparin, using a standard protocol of tinzaparin delivery at the initiation and midpoint of HD. Results: All 16 patients in The Ottawa Hospital INHD program were converted to tinzaparin and followed for 177 INHD sessions. Mean antifactor Xa level at 2 h of HD was 0.41 ± 0.21 (SD) IU/mL, at 4 h (mid-HD) 0.19 ± 0.17 IU/mL, at 6 h 0.44 ± 0.21 IU/mL, and at dialysis end 0.26 ± 0.14 IU/mL. Antifactor Xa levels were undetectable at the start of INHD, suggesting no tinzaparin accumulation. Five patients required an increase in tinzaparin due to extracorporeal dialysis circuit clotting. There were no bleeding events. One patient required a switch to fondaparinux due to an adverse reaction. Conclusion: Tinzaparin was safe and efficacious for most INHD patients without accumulation or bleeding. The conversion from unfractionated heparin to tinzaparin required an increased tinzaparin dose for 31% of INHD patients.
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
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