Gelatin in ICU and Sepsis

Phase 4

Terminated

• Conditions: Hypovolemia
• Interventions: Drug: Balanced electrolyte solution; Drug: Balanced gelatine solution

• Registration Number: NCT02715466
• Lead Sponsor: B. Braun Melsungen AG

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

Not available

Study Timeline

• Study First Submitted: 2016-03-17
• Study First Submitted QC: 2016-03-21
• Study First Posted: 2016-03-22
• Study Start: 2016-04
• Primary Completion: 2021-12-08
• Study Completion: 2021-12-08
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 167

Inclusion Criteria

• Male or female patients ≥ 18 years of age
• Women of child bearing potential must test negative on standard pregnancy test (urine or serum)
• Patients with body weight ≤ 140 kg
• Patients diagnosed severe sepsis / septic shock at admission on Intensive Care Unit who can be enrolled within 90 min after admission OR patients diagnosed severe sepsis / septic shock during Intensive Care Unit stay who can be enrolled within 90 min after diagnosis
• Patients where antibiotic therapy has already been started (prior to randomization)
• Patient who are fluid responsive. Fluid responsiveness is defined as increase of > 10% in mean arterial pressure (MAP) after passive leg raising (PLR)
• Signed informed consent by patient, legal representative or authorized person or deferred consent

Exclusion Criteria

• Administration of HES, dextrane solutions or > 500 ml of Gelatin solutions within the 24 h prior to randomization
• Death expected within the next 48 h (moribund patients as defined by ASA ≥ class V)
• Patients for whom the need of pressure infusions are expected
• Patients with confirmed acute SARS-CoV-2 (COVID-19) infection (as available from routine medical records/ patient chart)
• Requirement for renal support (either continuous or discontinuous techniques, including intermittent haemodialysis, haemofiltration and haemodiafiltration)
• Patients receiving therapeutic heparin medication due to chronic coagulation disease / anticoagulation medication (i.e. partial thromboplastin time > 60 sec)
• Acutely burned patients
• Contraindications according to summary of product characteristics of investigational test and reference product
• Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electrolyte	Balanced electrolyte solution	Balanced electrolyte solution
Gelatine	Balanced gelatine solution	Balanced gelatine solution
Gelatine	Balanced electrolyte solution	Balanced gelatine solution

Primary Outcome Measures

Name	Time	Method
Time until first/initial hemodynamic stabilization	48 hours after treatment start

Secondary Outcome Measures

Name	Time	Method
Length of stay (LOS) in the intensive care unit (ICU)	Intensive care unit (ICU) discharge or day 28

Trial Locations

Locations (12)

Masarykova nemocnice v Ústí nad Labem, o.z.; 🇨🇿 Ústí nad Labem, Czechia

Université de Nantes; 🇫🇷 Nantes, France

Hôpital Pasteur 2 - CHU de Nice; 🇫🇷 Nice, France

Universitätsklinikum Aachen; 🇩🇪 Aachen, Germany

Klinikum Bremen-Mitte; 🇩🇪 Bremen, Germany

Universitätsklinikum Frankfurt; 🇩🇪 Frankfurt am Main, Germany

Universitätsklinikum Tübingen; 🇩🇪 Tuebingen, Germany

Universitätsinstitut - Johannes Wesling Klinikum MInden; 🇩🇪 Minden, Germany

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Universitätsmedizin Rostock; 🇩🇪 Rostock, Germany

Medizinische Universität Innsbruck; 🇦🇹 Innsbruck, Austria