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
- Conditions
- Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]Hypovolaemia in Severe Sepsis / Septic ShockMedDRA version: 23.1Level: PTClassification code 10040070Term: Septic shockSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestations
- Registration Number
- EUCTR2015-000057-20-CZ
- Lead Sponsor
- B. Braun Melsungen AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 608
• Male or female patients = 18 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 started (prior to randomization).
• Patient 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
• Administration of HES, dextrane solutions or > 500ml of Gelatin solutions within 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:
Burns = 10 % of body surface area classified as third or second 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
• 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.
- Secondary Outcome Measures
Name Time Method