NCT01301469

Comparison of HES 130 in Balanced and in Unbalanced Solution

Prospective, Randomized, Double-blind, Controlled, Multicenter Study on the Efficacy and Safety of HES 130/0. 42 in a Balanced Electrolyte Solution vs a HES 130/0.4 in a Sodium Chloride Solution in Elective Surgery Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: B. Braun Melsungen AG · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of HES 130/0.42 in an electrolyte infusion in comparison to HES 130/0.4 in a sodium chloride infusion.

Conditions

• Decreased and Nonspecific Blood Pressure Disorders and Shock

Interventions

Type	Name	Description
DRUG	6% HES 130/0.42 in plasma adapted Ringer's solution	60 g/l hydroxyethyl starch 130 dissolved in plasma adapted Ringer's solution (balanced solution)
DRUG	6% HES 130/0.4 in a saline solution	60 g/l Hydroxyethyl starch (HES) with a mean molecular weight of 130 kDalton which is dissolved in a saline solution

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2011-02-23
• Last updated: 2012-01-05

Locations

4 sites across 1 country: China