6-month Follow up After Sevoflurane Postconditioning

November 2, 2016 updated by: University of Zurich

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland
        • University Hospital Zurich
      • Zurich, Switzerland
        • University Hospital of Zürich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients who had successfully completed the late postconditioning trial (NCT00924222) were included in this retrospective follow-up analysis.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the proportion of patients with cardiac events
Time Frame: 6 months after cardiac surgery
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
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
6 months after cardiac surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Beatrice Beck Schimmer, Prof, University Hospital Zurich, Anesthesiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

February 27, 2015

First Submitted That Met QC Criteria

February 27, 2015

First Posted (ESTIMATE)

March 4, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

November 3, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KEK ZH 2014-0040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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