NCT01127477

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

Examination of Volume Effect and Safety of 6 % Hydroxyethyl Starch 130/0.4 in Patients Undergoing Major Elective Surgery - an Uncontrolled, Open-labelled, Multi-centre Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Fresenius Kabi Japan · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage

Interventions

Type	Name	Description
DRUG	1: Hydroxyethyl starch 130/0.4, 6 %	1: Up to 50 ml 6 % hydroxyethyl starch 130/0.4/kg body weight administered intravenously from start of surgery (skin incision) until two hours after end of surgery.

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-05-21
• Last updated: 2012-06-26

Locations

4 sites across 1 country: Japan