MedTrace Logo

Gelatin in ICU and Sepsis

NCT02715466 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2025-08-19

Study results available
· View outcomes & findings →

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.

Conditions

  • Hypovolemia

Interventions

DRUG

Balanced gelatine solution

Gelaspan combined with Sterofundin ISO

DRUG

Balanced electrolyte solution

Sterofundin ISO

Sponsors & Collaborators

  • B. Braun Melsungen AG

    lead INDUSTRY

Principal Investigators

  • Gernot Marx, Prof. Dr. med. · Universitätsklinikum Aachen,Klinik für Operative Intensivmedizin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2021-12-08
Completion
2021-12-08

Countries

  • Austria
  • Czechia
  • France
  • Germany
  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02715466 on ClinicalTrials.gov