6-month Follow up After Sevoflurane Postconditioning

Overview

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)

Full Title of Study: “Late Postconditioning After Cardiac Surgery – Bridge From Surrogate Markers to Clinical Outcome”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: October 2014

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.

Interventions

  • Other: no intervention; retrospective study

Arms, Groups and Cohorts

  • cohort of RCT (StV 5-2007; NCT00924222)
    • Patient group with either sevoflurane or propofol sedation of the RCT (StV 5-2007; NCT00924222)

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Zurich
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Beatrice Beck Schimmer, Prof, Principal Investigator, University Hospital Zurich, Anesthesiology

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