Study of Remote Ischemic Postconditioning

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01450475

Enrollment

Registered

2011-10-12

Start date

2011-08-31

Completion date

2012-10-31

Last updated

2013-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bypass Complications, Ischemia

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.

Interventions

PROCEDURERemote 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 12 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026