Comparison of Albumin 5%, Hydroxyethyl Starch 130/0.4 (6%) and Ringer Lactate for volume replacement during cardiac surgery - n/a
- Conditions
- Intensive care patients after cardiac surgery requiring volume therapy
- Registration Number
- EUCTR2005-005040-85-AT
- Lead Sponsor
- Department of Anesthesia, Div. of Cardiothoracic and Vascular Anesthesia, Medical University Vienna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
1) Patients undergoing elective cardiac surgery using cardiopulmonary bypass including coronary artery bypass grafting (CABG), valve repair or replacement, and Aorta ascendens surgery
2) Age > 18 years
3) Written informed consent obtained
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1) Known allergy to Hydroxyethyl starch or Albumin
2) Aspirin use less than 3 days before surgery
3) GPIIbIIIa antagonists use less than 7 days before surgery
4) Coagulation disorders (INR > 1.2, aPTT > 40sec, platelet count < 100.000)
5) BMI > 40
6) Left ventricular ejection fraction < 15%
7) Renal dysfunction defined as serum creatinine >1.5mg/dl
8) Proven heparin induced thrombocytopenia (Danaparoid, Lepirudin use less than 1 month)
9) Deny of consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method