Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-02-03 @ 2:38 PM
Study NCT ID:
NCT02715466
Status:
TERMINATED
Last Update Posted:
2025-08-19
First Post:
2016-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gelatin in ICU and Sepsis
Sponsor:
B. Braun Melsungen AG
Organization:
Study Overview
Official Title:
Prospective, Controlled, Double-Blind, Randomized Multicentric Study On The Efficacy And Safety Of An Early Target Controlled Plasma Volume Replacement Therapy With A Balanced Gelatine Solution vs A Balanced Electrolyte Solution In Patients With Severe Sepsis
Status:
TERMINATED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
recommended by DSMB
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GENIUS
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: