Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-25 @ 11:01 PM
Study NCT ID:
NCT01260259
Status:
COMPLETED
Last Update Posted:
2013-09-18
First Post:
2010-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Seattle Cardiorenal Remote Ischemic Preconditioning Trial
Sponsor:
Seattle Children's Hospital
Organization:
Study Overview
Official Title:
Effect of Remote Ischemic Preconditioning in Children Undergoing Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2013-09
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:
SCRIPT
Brief Summary:
Remote Ischemic Preconditioning (RIPC) is a treatment that may be associated with improved outcomes after cardiac surgery. It can be elicited noninvasively by using a tourniquet to elicit transient ischemia over a lower extremity. It is thought to promote anti-inflammatory and cell survival pathways, and thus protect remote organs against future ischemic injury. We hypothesize that compared to sham treatment, RIPC will be associated with decreased post-operative acute kidney, myocardial, and lung injury.
Detailed Description:
In children undergoing cardiac surgery and cardiopulmonary bypass (CPB), our primary aims are to determine whether RPC is associated with: 1) decreased AKI and 2) decreased acute myocardial injury. Secondary aims include investigating the effects of RPC on post-procedure: 1)acute lung injury and 2) morbidity/mortality.
Study Oversight
Has Oversight DMC:
True
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?: