Humanalbumin, Hydroxyethylstarch and Ringer Lactate During Cardiac Surgery
Phase 4
Completed
- Conditions
- Valvular Heart DiseaseCoronary Artery Disease
- Interventions
- Drug: Humanalbumin 5%Drug: volume replacement
- Registration Number
- NCT01174719
- Lead Sponsor
- Medical University of Vienna
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria
- Valve replacement
- Coronary bypass surgery
Exclusion Criteria
- Severe left ventricular dysfunction
- Coagulation disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Humanalbumin Humanalbumin 5% - Hydroxyethylstarch volume replacement - Ringer lactate volume replacement -
- Primary Outcome Measures
Name Time Method chest tube drainage 24 hours
- Secondary Outcome Measures
Name Time Method Hemoglobin concentration 24 hours after surgery platelet count 24 hrs after surgery Hematocrit value 24 hours after surgery activated clotting time 30 minutes after arrival ICU Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany) 24 hrs after surgery using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)
Trial Locations
- Locations (1)
Vienna General Hospital
🇦🇹Vienna, Austria