NCT01117649

Plasma Volume Replacement (PVR) Therapy With Colloid and Crystalloid Solutions

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: B. Braun Melsungen AG · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Plasma Volume Replacement
• Surgery of the Pancreatic Head

Interventions

Type	Name	Description
DRUG	HES 10%	HES 10% dissolved in plasma adapted Ringer's solution (balanced solution).
DRUG	HES 6%	HES 6% dissolved in plasma adapted Ringer's solution (balanced solution)
DRUG	balanced electrolyte solution	plasma adapted Ringer's solution

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-07-01
• Completion: 2013-07-01
• First posted: 2010-05-05
• Last updated: 2016-12-23

Locations

3 sites across 1 country: Germany