EUCTR2015-000057-20-ATActive, not recruitingPhase 1
PROSPECTIVE, RANDOMIZED, CONTROLLED, DOUBLE-BLIND, MULTI-CENTRIC, INTERNATIONAL, STUDY ON THE EFFICACY AND SAFETY OF AN EARLY TARGET CONTROLLED PLASMA VOLUME REPLACEMENT THERAPY WITH A BALANCED GELATIN SOLUTION VS A BALANCED ELECTROLYTE SOLUTION IN PATIENTS WITH SEVERE SEPSIS / SEPTIC SHOCK - GENIUS (GELATIN IN ICU AND SEPSIS)
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- B. Braun Melsungen AG
- Enrollment
- 608
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 (refer to section 7.2.1 for definitions) at admission on ICU who can be enrolled within 90 min after admission OR patients diagnosed severe sepsis / septic shock during ICU stay who can be enrolled within 90 min after diagnosis
- •Patients where antibiotic therapy has already been started (prior to randomization)
- •Patients who are fluid responsive. Fluid responsiveness is defined as increase of > 10% in mean arterial pressure (MAP) after PLR or fluid challenge (max. 250 ml crystalloid solution)
- •Signed informed consent by patient, legal representative or authorized person or deferred consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 304
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 304
Exclusion Criteria
- •Administration of HES, dextrane solutions or > 500 ml Gelatin solution within the 24 h prior to randomization
- •Death expected within the next 48 h (moribund patients as defined by ASA = class V)
- •Patients with confirmed acute SARS-CoV-2 (COVID-19) infection (as available from routine medical records/ patient chart)
- •Patients for whom the need of pressure infusions are expected
- •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:
- •Burns are defined as having any of the following before the administration of investigational products:
- •1. Burns > 10 % of body surface area classified as third or second-degree yet re-epithelialised
- •Renal failure with oliguria or anuria
- •Severe general oedema
- •Severe congestive cardiac failure
- •Hypersensitivity to the active substance or ingredients of the IPs
- •Hypersensitivity to galactose-a-1,3-galactose (alpha-Gal) or known allergy to red meat (mammal meat) and offal
- •Hypervolaemia / hyperhydration
- •Hyperkalaemia
- •Hypercalcaemia
- •Metabolic alkalosis
- •Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)
Investigators
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