Gelatin in ICU and Sepsis

NCT02715466 | Terminated Phase 4 Results DMC

• 1 other identifier: HC-G-H-1209
• Study Type: interventional
• Target: 167
• Locations: 5 countries
• Sites: 12

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

Outcome Measures

Primary Outcomes (1)

• Time Until First/Initial Hemodynamic Stabilization

  Time from first administration of IMP to first achievement of confirmed hemodynamic stability

  48 hours after treatment start

Secondary Outcomes (1)

• Length of Stay (LOS) in the Intensive Care Unit (ICU)

  Intensive care unit (ICU) discharge or day 28

Study Arms (2)

Gelatine

EXPERIMENTAL

Balanced gelatine solution

Drug: Balanced gelatine solution; Drug: Balanced electrolyte solution

Electrolyte

ACTIVE COMPARATOR

Balanced electrolyte solution

Drug: Balanced electrolyte solution

Interventions

Balanced gelatine solution DRUG

Gelaspan combined with Sterofundin ISO

Gelatine

Balanced electrolyte solution DRUG

Sterofundin ISO

Electrolyte; Gelatine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• B. Braun Melsungen AG: lead

Study Sites (12)

Medizinische Universität Innsbruck

Innsbruck, 6020, Austria

Location

Masarykova nemocnice v Ústí nad Labem, o.z.

Ústí nad Labem, 401 13, Czechia

Location

Université de Nantes

Nantes, 44093, France

Location

Hôpital Pasteur 2 - CHU de Nice

Nice, 06000, France

Location

Universitätsklinikum Aachen

Aachen, 52074, Germany

Location

Klinikum Bremen-Mitte

Bremen, 28177, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, 60590, Germany

Location

Universitätsinstitut - Johannes Wesling Klinikum Minden

Minden, 32427, Germany

Location

Universitätsmedizin Rostock

Rostock, 18057, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Related Publications (1)

• 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.

  PMID: 34078421 DERIVED

MeSH Terms

Conditions

Hypovolemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Manager
• Organization: B. Braun Melsungen AG

studies@bbraun.com

00495661/71

Study Officials

• Gernot Marx, Prof. Dr. med.

  Universitätsklinikum Aachen,Klinik für Operative Intensivmedizin

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 22, 2016
• Study Start: April 1, 2016
• Primary Completion: December 8, 2021
• Study Completion: December 8, 2021
• Last Updated: August 19, 2025
• Results First Posted: August 19, 2025

Record last verified: 2025-08

Locations

AU (1); DE (6); FR (2); ES (2); CZ (1)