Overview

Study to Obtain Volume Effect and Safety Data on 6 % Hydroxyethyl Starch 130/0.4 in Pediatric and Adult Patients Undergoing Major Elective Surgery

Status:
Completed

Trial end date:
2010-12-01

Target enrollment:

Participant gender:

Summary

The study shall evaluate the volume effect and safety of 6 % hydroxyethyl starch 130/0.4 for restoration and maintenance of hemodynamics during the investigational period in patients undergoing major elective surgery. Up to 50 mL 6% hydroxyethyl starch/kg body weight will be administered from start of surgery until two hours after end of surgery. The study hypothesis is that 6 % hydroxyethyl starch 130/0.4 will have a reliable volume effect and can be safely administered up to the dose limit.

Phase:

Phase 3

Details

Lead Sponsor:

Fresenius Kabi Japan

Treatments:

Hydroxyethyl Starch Derivatives