Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-27 @ 10:23 PM
Study NCT ID:
NCT01338961
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2011-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normothermia Versus Hypothermia for Valvular Surgery Patients
Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Organization:
Study Overview
Official Title:
Normothermia Versus Hypothermia for Patients With Valvular Heart Disease Operated Under Cardiopulmonary Bypass.
Status:
COMPLETED
Status Verified Date:
2013-10
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:
Cardiopulmonary bypass (CPB) has been used successfully for cardiac surgery for over half a century. Hypothermia became a ubiquitous practice for adult patients undergoing CPB. To date, most studies have been conducted in coronary artery bypass graft (CABG) patients with conflicting results. Current evidence does not support one temperature management strategy for all patients. The purpose of this study is to compare the efficiency and safety of normothermic versus hypothermic CPB in valvular surgery patients.
Detailed Description:
None
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?: