Trials / Terminated
TerminatedNCT02715466
Gelatin in ICU and Sepsis
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
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 167 (actual)
- Sponsor
- B. Braun Melsungen AG · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Balanced gelatine solution | Gelaspan combined with Sterofundin ISO |
| DRUG | Balanced electrolyte solution | Sterofundin ISO |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2021-12-08
- Completion
- 2021-12-08
- First posted
- 2016-03-22
- Last updated
- 2025-08-19
- Results posted
- 2025-08-19
Locations
12 sites across 5 countries: Austria, Czechia, France, Germany, Spain
Source: ClinicalTrials.gov record NCT02715466. Inclusion in this directory is not an endorsement.