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: 20.0Level: PTClassification code 10040070Term: Septic shockSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-05
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

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

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)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Investigate the efficacy of early goal directed fluid management of a combination of a gelatin and crystalloid regime in comparison to a pure crystalloid regime in achieving haemodynamic stability (HDS) in patients with severe sepsis / septic shock.;Secondary Objective: Investigation of safety and efficacy parameters of the applied fluid regimes.;Primary end point(s): Time until first / initial HDS is achieved (in minutes).<br>;Timepoint(s) of evaluation of this end point: Time measurement will start with first administration of IPs and will be continued until first HDS is achieved.