Gelatin in ICU and Sepsis (GENIUS)

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

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.

Study Overview

• Status: Terminated
• Conditions: Hypovolemia
• Intervention / Treatment: Drug: Balanced gelatine solution; Drug: Balanced electrolyte solution

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Medizinische Universität Innsbruck
• Czechia
  • Ústí nad Labem, Czechia, 401 13
    • Masarykova nemocnice v Ústí nad Labem, o.z.
• France
  • Nantes, France, 44093
    • Université de Nantes
  • Nice, France, 06000
    • Hôpital Pasteur 2 - CHU de NICE
• Germany
  • Aachen, Germany, 52074
    • Universitätsklinikum Aachen
  • Bremen, Germany, 28177
    • Klinikum Bremen-Mitte
  • Frankfurt am Main, Germany, 60590
    • Universitatsklinikum Frankfurt
  • Minden, Germany, 32427
    • Universitätsinstitut - Johannes Wesling Klinikum MInden
  • Rostock, Germany, 18057
    • Universitätsmedizin Rostock
  • Tuebingen, Germany, 72076
    • Universitätsklinikum Tübingen
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gelatine; Balanced gelatine solution	Drug: Balanced gelatine solution; Gelaspan combined with Sterofundin ISO; Drug: Balanced electrolyte solution; Sterofundin ISO
Active Comparator: Electrolyte; Balanced electrolyte solution	Drug: Balanced electrolyte solution; Sterofundin ISO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time until first/initial hemodynamic stabilization	48 hours after treatment start

Secondary Outcome Measures

Outcome Measure	Time Frame
Length of stay (LOS) in the intensive care unit (ICU)	Intensive care unit (ICU) discharge or day 28

Collaborators and Investigators

• Sponsor: B. Braun Melsungen AG
• Investigators: Study Chair: Gernot Marx, Prof. Dr. med., Universitätsklinikum Aachen,Klinik für Operative Intensivmedizin

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): December 8, 2021
• Study Completion (Actual): December 8, 2021

Study Registration Dates

• First Submitted: March 17, 2016
• First Submitted That Met QC Criteria: March 21, 2016
• First Posted (Estimate): March 22, 2016

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 13, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hypovolemia; Pharmaceutical Solutions
• Other Study ID Numbers: HC-G-H-1209