drugset / Trial / NCT05391607

Comparison Between Hyperoncotic and Isooncotic Albumin to Support Blood Loss Replacement

NCT05391607

Phase 4 Completed 42 enrolled Insel Gruppe AG, University Hospital Bern
RandomizedParallel-groupOpen-labelTreatment

Summary

Fluid intravascular replacement is usually performed with either balanced crystalloids or iso-oncotic colloids, (synthetic colloids, plasma and 5% albumin). Doubts have been raised about synthetic colloids, and albumin solutions have been used more extensively. Albumin is the main protein responsible for plasma oncotic pressure and its volume expansion effect. The mobilization of extravascular fluid by infusing a hyper-oncotic solution like 20% albumin solution has been shown, causing endogenous fluid recruitment and blood volume expansion. The primary objective of this study is to compare the effect on plasma volume expansion and fluid recruitment of 3 different types of fluids (Albumin 5% and Albumin 20% and Ringer-lactate) during the hemorrhagic phase of the cystectomy procedure. Secondary objectives are the assessment of the hemodynamic parameters during surgery and the follow-up of pro-ANP and pro-BNP peptides. Glycocalyx proteins will be followed to evaluate endothelial wall shedding and microcirculation damages.

Timeline

Start
2022-05-25
Primary completion
2023-03-30
Completion
2023-04-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Albumin Protein / enzyme biologic 3 unknown Intravenous
Subject Albumin Protein / enzyme biologic 12 unknown Intravenous
Comparator Ringer's Lactate Crystalloid Solutions Unknown Intravenous

Indications

No indication recorded.