GENIUS: Gelatin in ICU and Sepsis

Sponsor

B. Braun Melsungen AG (Industry)

Overall Status

Terminated

CT.gov ID

NCT02715466

Collaborator

(none)

167

Enrollment

Locations

Arms

68.2

Duration (Months)

13.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypovolemia	Drug: Balanced gelatine solution Drug: Balanced electrolyte solution	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

167 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Dec 8, 2021

Actual Study Completion Date :

Dec 8, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Time until first/initial hemodynamic stabilization [48 hours after treatment start]

Secondary Outcome Measures

Length of stay (LOS) in the intensive care unit (ICU) [Intensive care unit (ICU) discharge or day 28]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Medizinische Universität Innsbruck	Innsbruck	Austria	6020
2	Masarykova nemocnice v Ústí nad Labem, o.z.	Ústí nad Labem	Czechia	401 13
3	Université de Nantes	Nantes	France	44093
4	Hôpital Pasteur 2 - CHU de Nice	Nice	France	06000
5	Universitätsklinikum Aachen	Aachen	Germany	52074
6	Klinikum Bremen-Mitte	Bremen	Germany	28177
7	Universitätsklinikum Frankfurt	Frankfurt am Main	Germany	60590
8	Universitätsinstitut - Johannes Wesling Klinikum MInden	Minden	Germany	32427
9	Universitätsmedizin Rostock	Rostock	Germany	18057
10	Universitätsklinikum Tübingen	Tuebingen	Germany	72076
11	Hospital Universitari Vall d'Hebron	Barcelona	Spain	08035
12	Hospital Universitario La Paz	Madrid	Spain	28046

Sponsors and Collaborators

B. Braun Melsungen AG

Investigators

Study Chair: Gernot Marx, Prof. Dr. med., Universitätsklinikum Aachen,Klinik für Operative Intensivmedizin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

B. Braun Melsungen AG

ClinicalTrials.gov Identifier:

NCT02715466

Other Study ID Numbers:

HC-G-H-1209

First Posted:

Mar 22, 2016

Last Update Posted:

May 19, 2022

Last Verified:

May 1, 2022

Additional relevant MeSH terms:

Hypovolemia

Pharmaceutical Solutions

Study Results

No Results Posted as of May 19, 2022