Prospective, Controlled, Double-blind, Randomized Multi-centric Study on the Efficacy and Safety of a Target Controlled PVR Therapy With a Hyperoncotic Balanced Hydroxyethyl Starch (HES) Solution Versus an Isooncotic Balanced HES Solution Compared to a Balanced Electrolyte Solution in Elective Surgery
Overview
- Phase
- Phase 4
- Intervention
- HES 6%
- Conditions
- Plasma Volume Replacement
- Sponsor
- B. Braun Melsungen AG
- Enrollment
- 63
- Locations
- 3
- Primary Endpoint
- First endpoint: Intraoperatively required amount of HES (10%, 6%) (ml)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
2
iso-oncotic colloid
Intervention: HES 6%
1
hyper-oncotic colloid
Intervention: HES 10%
3
crystalloid
Intervention: balanced electrolyte solution
Outcomes
Primary Outcomes
First endpoint: Intraoperatively required amount of HES (10%, 6%) (ml)
Time Frame: up to 8 hours
Goal-directed (stroke volume) plasma volume therapy
Second endpoint: Time until fully on oral (solid) diet (days)
Time Frame: up to 15 days
Secondary Outcomes
- haemodynamics, arterial blood gas analysis, laboratory data, postoperative nausea and vomiting, adverse events, nursing delirium screening scale, several injury scores(up to 7 days)