Hypovolaemia in Severe Sepsis / Septic Shock MedDRA version: 18.0 Level: PT Classification code 10040070 Term: Septic shock System Organ Class: 10021881 - Infections and infestations MedDRA version: 18.0 Level: PT Classification code 10040047 Term: Sepsis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Gelafundin ISO 40 mg/ml Infusionslösung
Product Name: Gelaspan
Pharmaceutical Form: Solution for infusion
CAS Number: 8000049276
Other descriptive name: SUCCINYLATED GELATIN
Concentration
Sponsors
B. Braun Melsungen AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). ;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
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: See section E.5.2;Secondary end point(s): • Safety -Renal function Serum creatinine (SCr) Serum blood urea nitrogen (BUN) Urine creatinine Estimated glomerular filtration rate (eGFR) Creatinine clearance Need and indication of renal replacement therapy (RRT) Urine output Kidney Disease Improving Global Outcome (KDIGO) score -Coagulation Prothrombin time (PT) Activated partial thromboplastin time (aPTT) International norm ratio (INR) ROTEM (optional) -Hepatic function Bilirubin Adverse Events (Serious) adverse events ((S)AEs) / reactions ((S)ARs) -Other Number of red blood cell (RBC) units Number of fresh frozen plasma (FFP) units Number of other blood products Vasopressor therapy Inotropic therapy - Efficacy Fluid administration according to the volume algorithm Volume needed to achieve first / initial HDS Total volume until 48 h after randomization Administered bottles Additional administered crystalloid solutions for further volume treatment Drug and volume Fluid balance Fluid intake Fluid output Fluid balance Haemodynamics Volume responsiveness upon passive leg raising (PLR) or exogenous fluid challenge Haemodynamic readings as required by the volume algorithm and haemodynamics from 48 h after randomization until ICU discharge or day 28, whatever occurs first -Tissue oxygenation and acid base balance Arterial blood gas analyses (BGA) Serum electrolytes Base excess (BE) Lactate / lactate decrease Phosphate Magnesium Central venous BGA Arterial oxygen content Oxygen delivery Perfusion index (optional) pCO2 gap (optional) • Outcome Length of stay (LOS) in the intensive care unit (ICU) Hospital LOS Days on RRT Number of infection free days Number of antibiotic free days Number of ventilator free days Number of vasopressor free days -Follow-up Last available SCr (day 28) Colloid therapy (day 28) Mortality & cause of death (if applicable) (day 28 & day 90) Healt | — |
Countries
Austria, Czech Republic, Germany, Hungary, Spain
Contacts
Public ContactClinical Operations
Accovion GmbH
Outcome results
None listed