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Gelatin in ICU and Sepsis (GENIUS)

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ClinicalTrials.gov Identifier: NCT02715466
Recruitment Status : Recruiting
First Posted : March 22, 2016
Last Update Posted : December 16, 2020
Sponsor:
Information provided by (Responsible Party):
B. Braun Melsungen AG

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 608 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 : April 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

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




Primary Outcome Measures :
  1. Time until first/initial hemodynamic stabilization [ Time Frame: 48 hours after treatment start ]

Secondary Outcome Measures :
  1. Length of stay (LOS) in the intensive care unit (ICU) [ Time Frame: Intensive care unit (ICU) discharge or day 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715466


Contacts
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Contact: Study Manager +49-5661-71-0 studies@bbraun.com

Locations
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Austria
Medizinische Universität Innsbruck Recruiting
Innsbruck, Austria, 6020
Contact: Dietmar Fries, Prof. Dr. med.         
Czechia
Fakultní nemocnice Hradec Králové Withdrawn
Hradec Králové, Czechia, 50005
Masarykova nemocnice v Ústí nad Labem, o.z. Recruiting
Ústí nad Labem, Czechia, 401 13
Contact: Vladimír Černý, Prof. MUDr., PhD         
France
Université de Nantes Completed
Nantes, France, 44093
Hôpital Pasteur 2 - CHU de Nice Completed
Nice, France, 06000
Germany
Universitätsklinikum Aachen Recruiting
Aachen, Germany, 52074
Contact: Gernot Marx, Univ.-Prof. Dr. med.         
Klinikum Bremen-Mitte Recruiting
Bremen, Germany, 28177
Contact: Rolf Dembinski, Prof. Dr. med.         
Universitätsklinikum Frankfurt Recruiting
Frankfurt am Main, Germany, 60590
Contact: Kai Zacharowski, Univ.-Prof. Dr. Dr. med.         
Universitätsinstitut - Johannes Wesling Klinikum MInden Recruiting
Minden, Germany, 32427
Contact: Bernd Bachmann-Mennenga, Prof. Dr. med.         
Universitätsmedizin Rostock Recruiting
Rostock, Germany, 18057
Contact: Tobias Schuerholz, Prof. Dr. med.         
Universitätsklinikum Tübingen Completed
Tuebingen, Germany, 72076
Hungary
Szegedi Tudományegyetem - Általános Orvostudományi Kar Withdrawn
Szeged, Hungary, 6725
Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Ricard Ferrer, Dr. med.         
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Manuel Sanchez, Dr. med.         
Hospital Universitario Virgen Macarena Withdrawn
Sevilla, Spain, 41009
Sponsors and Collaborators
B. Braun Melsungen AG
Investigators
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Study Chair: Gernot Marx, Prof. Dr. med. Universitätsklinikum Aachen,Klinik für Operative Intensivmedizin
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Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT02715466    
Other Study ID Numbers: HC-G-H-1209
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020
Additional relevant MeSH terms:
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Hypovolemia
Pathologic Processes
Pharmaceutical Solutions