Study of Remote Ischemic Postconditioning

Phase 1

Completed

• Conditions: Ischemia; Bypass Complications
• Interventions: Procedure: Remote ischemic postconditioning

• Registration Number: NCT01450475
• Lead Sponsor: Xijing Hospital

Brief Summary

Cardiac surgery is associated with cardiac and cerebral injury because of ischemia/reperfusion in approximately one third of cases. Ischemic preconditioning (IPC), have been shown to reduce the extent of myocardial infarction (MI). As another ischemic conditioning, remote ischemic postconditioning, limits MI size in animal models. The purpose of this study is to evaluate the cardiac and cerebral protective effect of remote ischemic postconditioning in children undergoing cardiac surgery, as a single-center, randomized controlled trial.

Detailed Description

Cardiac surgery is associated with Troponin release because of ischemia/reperfusion injury in approximately one third of cases. And I/R injury may also induce cerebral insult, even Postoperative Cognitive Dysfunction (POCD).Transient sublethal episodes of ischemia before a prolonged ischemia/reperfusion injury, known as ischemic preconditioning (IPC), have been shown to reduce the extent of myocardial infarction (MI).And remote ischemic postconditioning(RIPoC), as another ischemic condition, limits MI size in animal models.

However, there are limited outcome to demonstrate protection from RIPoC during cardiac surgery. The purpose of this study is to investigate the cardiac and cerebral protective effect of remote ischemic postconditioning , as a single-center, randomized controlled trial.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-10-09
• Study First Submitted QC: 2011-10-11
• Study First Posted: 2011-10-12
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-22
• Last Update Posted: 2013-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• All Children aged from 0 to 12 who are undergoing open congenital cardiac surgery.

Exclusion Criteria

• Simple atrial septal defect
• Bidirectional cavopulmonary shunt undergoing Fontan completion
• Chromosomal defects
• Airway or parenchymal lung disease
• Immunodeficiency
• Blood disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote ischemic postconditioning	Remote ischemic postconditioning	At the time of reperfusion, remote ischaemic postconditioning will be induced by inflating a cuff around leg to 100 mmHg for 5 mins followed by 5 mins of reperfusion. This cycle will be repeated 3 times.

Primary Outcome Measures

Name	Time	Method
cTnI,CK-MB concentration	24h after Remote Ischemic Postconditioning	The primary outcome is assessing whether cTnI or CK-MB concentration reduce at 24 hours after remote ischemic postconditioning.

Secondary Outcome Measures

Name	Time	Method
NSE，S100β concentration	24 hours after Remote Ischemic Postconditioning	The secondary outcome is assessing whether NSE or S100-β concentration reduce at 24 hours after remote ischemic postcondioning.

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China