Study of Remote Ischemic Postconditioning

A Randomized Control Trial of Effect of Remote Ischemic Postconditioning on Children Undergoing Cardiac Surgery

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.

Study Overview

• Status: Completed
• Conditions: Ischemia; Bypass Complications
• Intervention / Treatment: Procedure: Remote ischemic postconditioning

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Procedure: 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.; Other Names: Limb ischemic postconditioning
NO_INTERVENTION: control; A blood cuff was around leg without inflation or deflation.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Study Director: Wang Qiang, doctor, Xijing Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: October 9, 2011
• First Submitted That Met QC Criteria: October 11, 2011
• First Posted (ESTIMATE): October 12, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 24, 2013
• Last Update Submitted That Met QC Criteria: July 22, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: mazuike-18