An observational study in Heart Surgical Procedures, sponsored by University of Zurich. Completed at 2 sites in Switzerland. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-11-03.
Sponsored by University of Zurich · Observational
Retrospective analysis of a 6-month follow up within a randomised controlled study in cardiac surgery with pharmacological postconditioning (sedation on intensive care unit with sevoflurane)
Introduction: In a recent randomized controlled (RCT; NCT00924222) trial the investigators demonstrated in 102 patients that late post-conditioning with sevoflurane performed in the intensive care unit (ICU) reduced myocardial injury. These patients presented with lower troponin T values on the first post-operative day compared with patients undergoing propofol sedation. In order to assess possible clinical relevant long-term implications in patients enrolled in this study, the current retrospective analysis is performed focusing on cardiac and non-cardiac events during the first six months after surgery.
Methods: All patients who had successfully completed the late post-conditioning trial were included in this follow-up. Primary and secondary endpoints were the proportion of patients experiencing cardiac and non-cardiac events, respectively. Additionally, therapeutic interventions such as initiation or change of drug therapy, interventional treatment or surgery were assessed.
University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.
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All patients who had successfully completed the late postconditioning trial (NCT00924222) were included in this retrospective follow-up analysis.
All patients who had successfully completed the late post-conditioning trial were included in this retrospective follow-up analysis. Written and informed consent of all patients included in the first study had to be available.
Patient group with either sevoflurane or propofol sedation of the RCT (StV 5-2007; NCT00924222)
Other: no intervention; retrospective study
the proportion of patients with cardiac events
dysrhythmias, congestive heart failure and cardiac ischemic event
Time frame: 6 months after cardiac surgery
proportion of patients experiencing non-cardiac events
acute or chronic pulmonary embolism, bleeding events, infections, cerebral events, acute and chronic kidney failure, defined as glomerular filtration rate below 60 ml/min
Time frame: 6 months after cardiac surgery
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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University of Zurich