Gelatin in ICU and Sepsis

Phase 4 Terminated 167 enrolled B. Braun Melsungen AG

RandomizedParallel-groupDouble-blindTreatment

Summary

This prospective, double-blind randomized controlled trial evaluates the differences in terms of efficacy and safety of gelatin based resuscitation as compared to crystalloid based resuscitation in two parallel groups of patients with severe sepsis / septic shock.

Timeline

Start: 2016-04
Primary completion: 2021-12-08
Completion: 2021-12-08

Outcome

Outcome not reported

Stopped: “recommended by DSMB”

Publications

Marx G, Zacharowski K, Ichai C, Asehnoune K, Cerny V, Dembinski R, Ferrer Roca R, Fries D, Molnar Z, Rosenberger P, Sanchez-Sanchez M, Schurholz T, Dehnhardt T, Schmier S, von Kleist E, Brauer U, Simon TP. Efficacy and safety of early target-controlled plasma volume replacement with a balanced gelatine solution versus a balanced electrolyte solution in patients with severe sepsis/septic shock: study protocol, design, and rationale of a prospective, randomized, controlled, double-blind, multicentric, international clinical trial : GENIUS-Gelatine use in ICU and sepsis. Trials. 2021 Jun 2;22(1):376. doi: 10.1186/s13063-021-05311-8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gelaspan	Other / unclassified	—	—
Subject	Sterofundin ISO	Other / unclassified	—	—

Indications

No indication recorded.