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)
Looking for future studies?
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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
WS-SAVE Study (Williams Syndrome Skin and Vessel Elasticity Study)
NCT02692846
Aortic Stenosis, Supravalvular, Aortic Valve Disease
Bethesda, Maryland, United States
View Trial DetailsRisk Communication Within Mexican-American Families
NCT00469339
Breast Cancer, Breast Diseases
Houston, Texas, United States
View Trial DetailsBlood Markers of Inflammation, Blood Clotting and Blood Vessel Function in HIV-infected Adults
NCT00776412
Blood-Borne Infections, Cardiovascular Diseases
Bethesda, Maryland, United States
View Trial DetailsLinks Between Inflammation and Cardiometabolic Diseases
NCT01934660
Cardiovascular Disease, Cardiovascular Diseases
Bethesda, Maryland, United States
View Trial Details