Valvular Heart Disease, Coronary Artery Disease
Conditions
Keywords
Hydroxyethylstarch, Humanalbumin, Ringer Lactate, patients undergoing cardiac surgery
Brief 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.
Interventions
Hydroxyethylstarch up to 50mL/kg/24 hrs
DRUGHumanalbumin 5%
Humanalbumin 5% up to 50 mL/kg/24 hours
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Valve replacement * Coronary bypass surgery
Exclusion criteria
* Severe left ventricular dysfunction * Coagulation disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| chest tube drainage | 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin concentration | induction of anesthesia = baseline | — |
| Hematocrit value | induction of anesthesia = baseline | — |
| platelet count | induction of anesthesia = baseline | — |
| activated clotting time | induction of anesthesia = baseline | — |
| Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany) | induction of anethesia = baseline | using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM) |
Countries
Austria
Outcome results
None listed