NCT01174719

Humanalbumin, Hydroxyethylstarch and Ringer Lactate During Cardiac Surgery

Phase 4 Study Comparing Albumin 5%, Hydroxyethylstrach 130/0.4 (6%) and Ringer Lactate for Volume Replacement During Cardiac Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to compare three different regimens for volume replacement during cardiac surgery, e.g. Albumin 5%, Hydroxyethylstarch 130/0.4 (HES) and Ringer-Lactate (RL). Main Outcome parameters: chest tube drainage and coagulation parameters. The investigators hypothesis is that HES is as safe as Albumin, however less expensive. Whether RL is an even less expensive and as safe alternative has to be shown.

Conditions

• Valvular Heart Disease
• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	volume replacement	Hydroxyethylstarch up to 50mL/kg/24 hrs
DRUG	Humanalbumin 5%	Humanalbumin 5% up to 50 mL/kg/24 hours
DRUG	volume replacement	up 10 50mL/kg/24 hours

Timeline

• Start date: 2006-03-01
• Primary completion: 2010-02-01
• Completion: 2010-04-01
• First posted: 2010-08-04
• Last updated: 2015-04-08

Locations

1 site across 1 country: Austria