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Completed

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)

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich, Zurich, Switzerland

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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

no intervention; retrospective study

Other

Primary outcomes

  1. the proportion of patients with cardiac events

    Time frame: 6 months after cardiac surgery

    dysrhythmias, congestive heart failure and cardiac ischemic event

Secondary outcomes

  1. 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.

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