Gelatin in ICU and Sepsis

• Register: ClinicalTrials.gov
• Last refreshed on: 23 May 2022
• Main ID: NCT02715466
• Date of registration: 17/03/2016
• Prospective Registration: Yes
• Primary sponsor: B. Braun Melsungen AG
• Public title: Gelatin in ICU and Sepsis GENIUS
• Scientific 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
• Date of first enrolment: April 2016
• Target sample size: 167
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02715466
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 4

Countries of recruitment

Austria, Czech Republic, Czechia, France, Germany, Hungary, Spain

Contacts

• Name: Gernot Marx, Prof. Dr. med.
• Affiliation: Universitätsklinikum Aachen,Klinik für Operative Intensivmedizin

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypovolemia

Intervention(s)

Drug: Balanced electrolyte solution

Drug: Balanced gelatine solution

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

HC-G-H-1209

Source(s) of Monetary Support

Please refer to primary and secondary sponsors