Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-03 @ 10:19 PM
Study NCT ID:
NCT02378168
Status:
COMPLETED
Last Update Posted:
2016-11-03
First Post:
2015-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
6-month Follow up After Sevoflurane Postconditioning
Sponsor:
University of Zurich
Organization:
Study Overview
Official Title:
Late Postconditioning After Cardiac Surgery - Bridge From Surrogate Markers to Clinical Outcome
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: