Gelatin in ICU and Sepsis

NCT ID: NCT02715466

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2021-12-08

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.

Conditions

Hypovolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Gelatine

Balanced gelatine solution

Group Type: EXPERIMENTAL

Balanced gelatine solution

Intervention Type: DRUG

Gelaspan combined with Sterofundin ISO

Balanced electrolyte solution

Intervention Type: DRUG

Sterofundin ISO

Electrolyte

Balanced electrolyte solution

Group Type: ACTIVE_COMPARATOR

Balanced electrolyte solution

Intervention Type: DRUG

Sterofundin ISO

Interventions

Balanced gelatine solution

Gelaspan combined with Sterofundin ISO

Intervention Type: DRUG

Balanced electrolyte solution

Sterofundin ISO

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B. Braun Melsungen AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gernot Marx, Prof. Dr. med.

Role: STUDY_CHAIR

Universitätsklinikum Aachen,Klinik für Operative Intensivmedizin

Locations

Medizinische Universität Innsbruck

Innsbruck, , Austria

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

Universitätsinstitut - Johannes Wesling Klinikum Minden

Minden, , Germany

Universitätsmedizin Rostock

Rostock, , Germany

Universitätsklinikum Tübingen

Tübingen, , Germany

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Countries

Austria; Czechia; France; Germany; Spain

References

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.

Reference Type: DERIVED

PMID: 34078421 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

HC-G-H-1209

Identifier Type: -

Identifier Source: org_study_id