6-month Follow up After Sevoflurane Postconditioning

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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Late Postconditioning After Cardiac Surgery - Bridge From Surrogate Markers to Clinical Outcome

Conditions
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Heart Surgical Procedures

Intervention / Treatment
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* Other: no intervention; retrospective study


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cohort of RCT (StV 5-2007; NCT00924222)<br>Patient group with either sevoflurane or propofol sedation of the RCT (StV 5-2007; NCT00924222) | Other: no intervention; retrospective study<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of patients with cardiac events | dysrhythmias, congestive heart failure and cardiac ischemic event | 6 months after cardiac surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months after cardiac surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postconditioning, six month follow up, cardiac event, non-cardiac event