Gelatin in ICU and Sepsis (GENIUS)

  • STATUS
    Recruiting
  • End date
    Dec 4, 2022
  • participants needed
    608
  • sponsor
    B. Braun Melsungen AG
Updated on 26 January 2022

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.

Details
Condition Hypovolemia
Treatment Balanced gelatine solution, Balanced electrolyte solution
Clinical Study IdentifierNCT02715466
SponsorB. Braun Melsungen AG
Last Modified on26 January 2022

Eligibility

Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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