6-month Follow up After Sevoflurane Postconditioning

Heart Surgical Procedures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02378168
• Other study ID #: KEK ZH 2014-0040
• Status: Completed
• Phase: N/A
• First received: February 27, 2015
• Last updated: November 2, 2016
• Start date: April 2014
• Est. completion date: November 2014

Study information

• Verified date: November 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Heart Surgical Procedures

Intervention

Other:
• no intervention; retrospective study

Locations

Country	Name	City	State
Switzerland	University Hospital of Zurich	Zurich
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the proportion of patients with cardiac events	dysrhythmias, congestive heart failure and cardiac ischemic event	6 months after cardiac surgery	No
Secondary	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	No