Cardiac On-pump Surgery Clinical Trial
| Verified date | October 2011 |
| Source | University of Zurich |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Swissmedic |
| Study type | Interventional |
Organ protection, volatile anesthetics, postconditioning.
Sedation of patients on ICU after cardiac surgery with cardiopulmonary bypass with either
propofol or sevoflurane. Evaluation of organ function and inflammatory mediators in the
blood.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | December 2009 |
| Est. primary completion date | November 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
Inclusion criteria: - CABG and/or heart valve surgery with CPB - Ejection fraction (EF) = 30% - Canadian Cardiovascular Society (CCS) classification = 3 - Ages 18 to 90 years old Exclusion criteria: - Pulmonary disease: forced expiratory volume in one second (FEV1) < 80%; FEV1/forced vital capacity (FVC) < 70% - Renal disease and/ or creatinine-clearance < 60 ml/min - Previous cardiac surgery - Emergency procedures - Postoperative intra aortic balloon pump (IABP) requirement - Myocardial infarction < 7d - Steroid treatment - Insulin-dependent diabetes - Pregnancy |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University of Zurich |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Myocardial injury markers (myoglobin, creatine kinase, myocard specific creatine kinase, and troponin T) | Start and end of ICU stay | No | |
| Secondary | Oxygenation index, postoperative pulmonary complications, ICU stay (days), length of hospitalisation | Start with surgery until end of hospitalisation | No |