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Gelatin in ICU and Sepsis (GENIUS)

Primary Purpose

Hypovolemia

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Balanced gelatine solution
Balanced electrolyte solution
Sponsored by
B. Braun Melsungen AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypovolemia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Medizinische Universität Innsbruck
  • Masarykova nemocnice v Ústí nad Labem, o.z.
  • Université de Nantes
  • Hôpital Pasteur 2 - CHU de Nice
  • Universitätsklinikum Aachen
  • Klinikum Bremen-Mitte
  • Universitätsklinikum Frankfurt
  • Universitätsinstitut - Johannes Wesling Klinikum MInden
  • Universitätsmedizin Rostock
  • Universitätsklinikum Tübingen
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitario La Paz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gelatine

Electrolyte

Arm Description

Balanced gelatine solution

Balanced electrolyte solution

Outcomes

Primary Outcome Measures

Time until first/initial hemodynamic stabilization

Secondary Outcome Measures

Length of stay (LOS) in the intensive care unit (ICU)

Full Information

First Posted
March 17, 2016
Last Updated
May 13, 2022
Sponsor
B. Braun Melsungen AG
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1. Study Identification

Unique Protocol Identification Number
NCT02715466
Brief Title
Gelatin in ICU and Sepsis
Acronym
GENIUS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
recommended by DSMB
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 8, 2021 (Actual)
Study Completion Date
December 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
B. Braun Melsungen AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gelatine
Arm Type
Experimental
Arm Description
Balanced gelatine solution
Arm Title
Electrolyte
Arm Type
Active Comparator
Arm Description
Balanced electrolyte solution
Intervention Type
Drug
Intervention Name(s)
Balanced gelatine solution
Intervention Description
Gelaspan combined with Sterofundin ISO
Intervention Type
Drug
Intervention Name(s)
Balanced electrolyte solution
Intervention Description
Sterofundin ISO
Primary Outcome Measure Information:
Title
Time until first/initial hemodynamic stabilization
Time Frame
48 hours after treatment start
Secondary Outcome Measure Information:
Title
Length of stay (LOS) in the intensive care unit (ICU)
Time Frame
Intensive care unit (ICU) discharge or day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gernot Marx, Prof. Dr. med.
Organizational Affiliation
Universitätsklinikum Aachen,Klinik für Operative Intensivmedizin
Official's Role
Study Chair
Facility Information:
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Masarykova nemocnice v Ústí nad Labem, o.z.
City
Ústí nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Université de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital Pasteur 2 - CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Universitätsklinikum Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Klinikum Bremen-Mitte
City
Bremen
ZIP/Postal Code
28177
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitätsinstitut - Johannes Wesling Klinikum MInden
City
Minden
ZIP/Postal Code
32427
Country
Germany
Facility Name
Universitätsmedizin Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
34078421
Citation
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.
Results Reference
derived

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Gelatin in ICU and Sepsis

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