EUCTR2015-000057-20-HUActive, 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)
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 and = 85 years of age
- •Women of child bearing potential must test negative on standard pregnancy test (urine or serum)
- •Patients with body weight = 55 kg and = 140 kg and body mass index (BMI) = 18 kg/m2 and = 35 kg/m2
- •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 already treated with antibiotic therapy (prior to randomization)
- •Patient who are fluid responsive. Fluid responsiveness is defined as increase of at least 10% in mean arterial pressure (MAP) after PLR
- •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 artificial colloids within the 24 h prior to randomization
- •Death expected within the next 48 h
- •Patients whose medical condition does preclude the PLR manoeuvre
- •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 heparin / anticoagulation therapy
- •Burned patients
- •Chronic renal failure with oliguria or anuria
- •Severe general oedema
- •Severe cardiac insufficiency (defined as NYHA = III)
- •Hypersensitivity to the active substance or ingredients of the IPs
- •Hypervolaemia / hyperhydration
- •Hyperkalaemia (requiring medical treatment)
- •Hypercalcaemia (requiring medical treatment)
- •Metabolic alkalosis
- •Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)
Investigators
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