Gelatin in ICU and Sepsis
- Conditions
- Hypovolemia
- Registration Number
- NCT02715466
- Lead Sponsor
- B. Braun Melsungen AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Male or female patients = 18 years of age<br><br> - Women of child bearing potential must test negative on standard pregnancy test<br> (urine or serum)<br><br> - Patients with body weight = 140 kg<br><br> - Patients diagnosed severe sepsis / septic shock at admission on Intensive Care Unit<br> who can be enrolled within 90 min after admission OR patients diagnosed severe<br> sepsis / septic shock during Intensive Care Unit stay who can be enrolled within 90<br> min after diagnosis<br><br> - Patients where antibiotic therapy has already been started (prior to randomization)<br><br> - Patient who are fluid responsive. Fluid responsiveness is defined as increase of ><br> 10% in mean arterial pressure (MAP) after passive leg raising (PLR)<br><br> - Signed informed consent by patient, legal representative or authorized person or<br> deferred consent<br><br>Exclusion Criteria:<br><br> - Administration of HES, dextrane solutions or > 500 ml of Gelatin solutions within<br> the 24 h prior to randomization<br><br> - Death expected within the next 48 h (moribund patients as defined by ASA = class V)<br><br> - Patients for whom the need of pressure infusions are expected<br><br> - Patients with confirmed acute SARS-CoV-2 (COVID-19) infection (as available from<br> routine medical records/ patient chart)<br><br> - Requirement for renal support (either continuous or discontinuous techniques,<br> including intermittent haemodialysis, haemofiltration and haemodiafiltration)<br><br> - Patients receiving therapeutic heparin medication due to chronic coagulation disease<br> / anticoagulation medication (i.e. partial thromboplastin time > 60 sec)<br><br> - Acutely burned patients<br><br> - Contraindications according to summary of product characteristics of investigational<br> test and reference product<br><br> - Simultaneous participation in another interventional clinical trial (drugs or<br> medical devices studies)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time until first/initial hemodynamic stabilization
- Secondary Outcome Measures
Name Time Method Length of stay (LOS) in the intensive care unit (ICU)