6-month Follow up After Sevoflurane Postconditioning

Completed

• Conditions: Heart Surgical Procedures
• Interventions: Other: no intervention; retrospective study

• Registration Number: NCT02378168
• Lead Sponsor: University of Zurich

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2014-10
• Study Completion: 2014-11
• Study First Submitted: 2015-02-27
• Study First Submitted QC: 2015-02-27
• Study First Posted: 2015-03-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-02
• Last Update Posted: 2016-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cohort of RCT (StV 5-2007; NCT00924222)	no intervention; retrospective study	Patient group with either sevoflurane or propofol sedation of the RCT (StV 5-2007; NCT00924222)

Primary Outcome Measures

Name	Time	Method
the proportion of patients with cardiac events	6 months after cardiac surgery	dysrhythmias, congestive heart failure and cardiac ischemic event

Secondary Outcome Measures

Name	Time	Method
proportion of patients experiencing non-cardiac events	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

Trial Locations

Locations (2)

University Hospital of Zurich; 🇨🇭 Zurich, Switzerland

University Hospital Zurich; 🇨🇭 Zurich, Switzerland