Comparison of Two Gelatine Solutions
- Registration Number
- NCT01515397
- Lead Sponsor
- B. Braun Melsungen AG
- Brief Summary
The aim of volume replacement is to compensate a reduction in the intravascular volume e.g. during surgery and to counteract hypovolemia in order to maintain hemodynamics and vital functions. To achieve this, different plasma substitutes are available: Albumin, dextran, hydroxyethylstarches and gelatine. The aim of this study is to demonstrate that acid-base alterations during elective abdominal surgery can be reduced by the use of a new gelatine solution.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description balanced gelatine solution Gelofusine balanced isotonic colloidal volume substitute non-balanced gelatine solution Gelofusine 4% colloidal volume substitute
- Primary Outcome Measures
Name Time Method base excess [mmol/l] Change from baseline at end of surgery, an expected average of 2 hours surgery chloride [mmol/l] Change from baseline at end of surgery, an expected average of 2 hours surgery
- Secondary Outcome Measures
Name Time Method time on ventilation until 12 hours after surgery arterial blood gase analyses until 12 hours after surgery coagulation status until 12 hours after surgery renal function until 12 hours after surgery adverse events until 12 hours after surgery hemodynamics (systolic and diastolic blood pressure) until 12 hours after surgery
Trial Locations
- Locations (2)
Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Frankfurt/Main
🇩🇪Frankfurt/Main, Germany
Universitätsklinikum Aachen, Klinik für Anästhesiologie
🇩🇪Aachen, Germany