Clinical trial NCT02715466: Gelatin in ICU and Sepsis
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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hypovolemia
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2016-03-22
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Time until first/initial hemodynamic stabilization
timeFrame: 48 hours after treatment start
Secondary outcomes:
measure: Length of stay (LOS) in the intensive care unit (ICU)
timeFrame: Intensive care unit (ICU) discharge or day 28
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Ústí nad Labem
country: Czechia
facility: Masarykova nemocnice v Ústí nad Labem, o.z.
city: Nantes
country: France
facility: Université de Nantes
city: Nice
country: France
facility: Hôpital Pasteur 2 - CHU de Nice
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Bremen
country: Germany
facility: Klinikum Bremen-Mitte
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt
city: Minden
country: Germany
facility: Universitätsinstitut - Johannes Wesling Klinikum MInden
city: Rostock
country: Germany
facility: Universitätsmedizin Rostock
city: Tuebingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Universitätsklinikum Aachen,Klinik für Operative Intensivmedizin
name: Gernot Marx, Prof. Dr. med.
role: STUDY_CHAIR
References:
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.