Comparison of the effect of 4% albumin and Ringer´s acetate in cardiopulmonary bypass (CPB) and intra- and postoperative volume replacement.
Phase 1
- Conditions
- Cardiac surgery with cardiopulmonary bypass operations. Elective and emergency patients.MedDRA version: 19.0Level: LLTClassification code 10017501Term: Functional disturbances following cardiac surgerySystem Organ Class: 100000004863Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2015-002556-27-FI
- Lead Sponsor
- Helsinki University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1250
Inclusion Criteria
age 18-90 years. following primary or repeat cardiac surgery procedures either independently or in combinations ( CABG, Valve-, MAZE, Surgery on the aortic root or ascending aorta not requiring hypothermic arrest). Elective or urgent surgery
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 625
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 625
Exclusion Criteria
Immediate emergency surgery (no time for recruitment), End-stage kidney disease,
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare 4% albumin / 20% albumin vs ringer´s acetate as a priming solution of cardiopulmonary bypass and intra- and postoperative volume replacement in composite endpoint´s.;Secondary Objective: Secondary on other adverse events and tertiary on biochemical and physiological values;Primary end point(s): Primary outcome: Composite endpoint´s: all cause death, acute myocardial infarction, repeated revascularisation, acute heart failure, resternotomy, stroke, arrhytmia, major bleeding, infections, acute kidney injury.;Timepoint(s) of evaluation of this end point: 90 days postop.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Total number of MAE´S, number of each type blood product transfused, fluid balance, blood loss, acute kidney injury, days alive without mecanical intubation in 90 days, days alive outside ICU 90 in days. Days alive at home in 90 d. 90 days mortality;Timepoint(s) of evaluation of this end point: 24 h postop, 90 days post op.