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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fresenius Kabi Japan
• Treatments: Hydroxyethyl Starch Derivatives

Criteria

Inclusion Criteria:

• Patients undergoing major elective surgery

• Adults patients (≥20 years of age): expected blood loss of ≥ 1000mL Pediatric patients (<20 years of age): expected blood loss ≥ 15 mL/kg

• Adult patients: Routine measurement of Central Venous Pressure (CVP)

Exclusion Criteria:

• Known or suspected allergy to hydroxyethyl starch, including its ingredients (inclusive corn) and related drugs

• ASA classification ≥ IV

• Adult patients: renal failure with oliguria (<400 mL urin /24hours) and anuria Pediatric patients: renal failure with oliguria and anuria not related to hypovolemia

• Known bleeding disorders

• Other contra-indications according to the current SmPC of Voluven 6% solution for infusion.