Gelatin in ICU and Sepsis

Hypovolemia Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02715466
• Other study ID #: HC-G-H-1209
• Status: Terminated
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: December 8, 2021

Study information

• Verified date: May 2022
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 167
• Est. completion date: December 8, 2021
• Est. primary completion date: December 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypovolemia

Intervention

Drug:
• Balanced gelatine solution
Gelaspan combined with Sterofundin ISO
• Balanced electrolyte solution
Sterofundin ISO

Locations

Country	Name	City	State
Austria	Medizinische Universität Innsbruck	Innsbruck
Czechia	Masarykova nemocnice v Ústí nad Labem, o.z.	Ústí nad Labem
France	Université de Nantes	Nantes
France	Hôpital Pasteur 2 - CHU de Nice	Nice
Germany	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	Tuebingen
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Countries where clinical trial is conducted

Austria,  Czechia,  France,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time until first/initial hemodynamic stabilization		48 hours after treatment start
Secondary	Length of stay (LOS) in the intensive care unit (ICU)		Intensive care unit (ICU) discharge or day 28