Ignite Creation Date:
2024-05-06 @ 8:11 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02681913
Status:
UNKNOWN
Last Update Posted:
2017-04-20
First Post:
2016-02-03
Brief Title:
Adenosine as an Adjunct to Blood Cardioplegia
Sponsor:
Amphia Hospital
Organization:
Amphia Hospital
Study Overview
Official Title:
The Effect of Adenosine on Myocardial Protection in Intermittent Warm Blood Cardioplegia A Randomized Placebo-controlled Trial
Status:
UNKNOWN
Status Verified Date:
2017-04
Last Known Status:
RECRUITING
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:
Myocardial protection is a major issue in cardiac surgery since inadequate protection increases the risk of postoperative cardiac dysfunction The main principle of myocardial protection in cardiac surgery is to preserve myocardial function by preventing ischemia with blood cardioplegia Previous studies have shown that adenosine as an adjunct to blood cardioplegia can be safely used in cardiac surgery In the Amphia Hospital adenosine is already used as standard care as an initial cardioplegic bolus in minimally invasive port access operations Whether adenosine as an adjunct to intermittent warm blood cardioplegia has an added value remains unclear Therefore the investigators would like to investigate the effect of the addition of adenosine to standard intermittent warm blood cardioplegia in patients scheduled for minimally invasive port access operations mitral valve surgery
Half of the participants will receive standard intermittent warm blood cardioplegia while the other half will receive intermittent warm blood cardioplegia enriched with adenosine
Half of the participants will receive standard intermittent warm blood cardioplegia while the other half will receive intermittent warm blood cardioplegia enriched with adenosine
Detailed Description:
Myocardial protection is a major issue in cardiac surgery since inadequate protection increases the risk of postoperative cardiac dysfunction The main principle of myocardial protection in cardiac surgery is to preserve myocardial function by preventing ischemia with blood cardioplegia Previous studies have shown that adenosine as an adjunct to blood cardioplegia can be safely used in cardiac surgery In the Amphia Hospital adenosine is already used as standard care as an initial cardioplegic bolus in minimally invasive port access operations Whether adenosine as an adjunct to intermittent warm blood cardioplegia has an added value remains unclear Therefore the investigators would like to investigate whether the addition of adenosine to standard intermittent warm blood cardioplegia reduces the 6-hours post-operative cardiac troponin T cTnT in patients scheduled for minimally invasive port access operations mitral valve surgery
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-001923-22 | EUDRACT_NUMBER | None | None |