Controlled, international study conducted in several centres on the therapeutic effect and safety of an early controlled plasma volume replacement treatment with a balanced gelatin solution tested against a balanced salt solution in patients with severe septis / septic shock

Phase 1

• Conditions: Hypovolaemia in Severe Sepsis / Septic Shock; MedDRA version: 18.0Level: PTClassification code 10040070Term: Septic shockSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 18.0Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2015-000057-20-HU
• Lead Sponsor: B. Braun Melsungen AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-27
• Last Update Posted: 19 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 608

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified