NCT Number: NCT02378168
6-month Follow up After Sevoflurane Postconditioning
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)
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Notify MeKey information
Conditions
Age range
18 year–90 year
Sex eligibility
All sexes
Study type
Observational
Primary location
University Hospital Zurich, Zurich, Switzerland
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
the proportion of patients with cardiac events
Time frame: 6 months after cardiac surgery
dysrhythmias, congestive heart failure and cardiac ischemic event
Secondary outcomes
-
proportion of patients experiencing non-cardiac events
Time frame: 6 months after cardiac surgery
acute or chronic pulmonary embolism, bleeding events, infections, cerebral events, acute and chronic kidney failure, defined as glomerular filtration rate below 60 ml/min
Sponsors and collaborators
Lead sponsor
University of Zurich
Other
Registry information
Official study title
Late Postconditioning After Cardiac Surgery - Bridge From Surrogate Markers to Clinical Outcome
Important dates
- Study start
- 2014
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Mar 4, 2015
- Registry last updated
- Nov 3, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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