NCT01553617

VolulyteTM in Cardiac Surgery

Efficacy and Safety of Perioperative Infusion of 6 % Hydroxyethyl Starch 130/0.4 in an Isotonic Electrolyte Solution (VolulyteTM) vs. 5% HSA as Volume Replacement Therapy During Cardiac Surgery for Adult Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Fresenius Kabi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will compare the efficacy and safety of VolulyteTM and human albumin in elective open-heart surgery in adult patients.

Conditions

• Heart; Dysfunction Postoperative, Cardiac Surgery

Interventions

Type	Name	Description
DRUG	6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM)	Study drug will be given as part of priming of the ECC and for volume therapy up to the maximum dosage of 50 mL/kg body weight/day
DRUG	Human serum albumin	Control drug will be given as part of priming of the ECC and for volume therapy up to the maximum dosage of 50 mL/kg body weight/day

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2012-03-14
• Last updated: 2014-06-26

Locations

5 sites across 1 country: Canada