Humanalbumin, Hydroxyethylstarch and Ringer Lactate During Cardiac Surgery

Medical University of Vienna

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease; Valvular Heart Disease

Treatments: Drug: volume replacement; Drug: Humanalbumin 5%

Study type: Interventional

Funder types: Other

Identifiers

NCT01174719

HAHes

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Valve replacement
• Coronary bypass surgery

Exclusion criteria

• Severe left ventricular dysfunction
• Coagulation disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

240 participants in 3 patient groups

Hydroxyethylstarch

Active Comparator group

Treatment:

Drug: volume replacement

Drug: volume replacement

Humanalbumin

Active Comparator group

Treatment:

Drug: Humanalbumin 5%

Ringer lactate

Active Comparator group

Treatment:

Drug: volume replacement

Drug: volume replacement