This prospective, double-blind randomized controlled trial evaluates the differences in terms of efficacy and safety of gelatin based resuscitation as compared to crystalloid based resuscitation in two parallel groups of patients with severe sepsis / septic shock.
Who can participate
Age range18 Years – 85 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 at admission on Intensive Care Unit who can be enrolled within 90 min after admission OR patients diagnosed severe sepsis / septic shock during Intensive Care Unit stay who can be enrolled within 90 min after diagnosis
* Patients where antibiotic therapy has already been started (prior to randomization)
* Patient who are fluid responsive. Fluid responsiveness is defined as increase of \> 10% in mean arterial pressure (MAP) after passive leg raising (PLR)
* Signed informed consent by patient, legal representative or authorized person or deferred consent
Exclusion Criteria:
* Administration of HES, dextrane solutions or \> 500 ml of Gelatin solutions within the 24 h prior to randomization
* Death expected within the next 48 h (moribund patients as defined by ASA ≥ class V)
* Patients for whom the need of pressure infusions are expected
* Patients with confirmed acute SARS-CoV-2 (COVID-19) infection (as available from routine medical records/ patient chart)
* 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.…
What they're measuring
1
Time Until First/Initial Hemodynamic Stabilization