Plasma Volume Replacement (PVR) Therapy With Colloid and Crystalloid Solutions
Phase 4
Completed
- Conditions
- Surgery of the Pancreatic HeadPlasma Volume Replacement
- Interventions
- Registration Number
- NCT01117649
- Lead Sponsor
- B. Braun Melsungen AG
- Brief Summary
The purpose of this study is to investigate the efficacy of target controlled fluid therapy with a hyper-oncotic balanced HES solution compared to an iso-oncotic HES solution in patients undergoing elective surgery of the pancreatic head. A third group receiving a balanced electrolyte solution (without colloidal volume replacement) will serve as a control for descriptive analysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 HES 10% hyper-oncotic colloid 2 HES 6% iso-oncotic colloid 3 balanced electrolyte solution crystalloid
- Primary Outcome Measures
Name Time Method First endpoint: Intraoperatively required amount of HES (10%, 6%) (ml) up to 8 hours Goal-directed (stroke volume) plasma volume therapy
Second endpoint: Time until fully on oral (solid) diet (days) up to 15 days
- Secondary Outcome Measures
Name Time Method haemodynamics, arterial blood gas analysis, laboratory data, postoperative nausea and vomiting, adverse events, nursing delirium screening scale, several injury scores up to 7 days
Trial Locations
- Locations (3)
Klinik für Anästhesie und operative Intensivmedizin, Charité-Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Klinik für Anästhesie, operative Intensivmedizin und Schmerztherapie, Humboldt Klinikum
🇩🇪Berlin, Germany
Universitätsklinikum Bonn
🇩🇪Bonn, Germany