Study of Remote Ischemic Postconditioning

Air Force Military Medical University of People's Liberation Army

Status and phase: Completed; Phase 1

Conditions: Bypass Complications; Ischemia

Treatments: Procedure: Remote ischemic postconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT01450475

mazuike-18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: Under 12 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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65 participants in 2 patient groups

Remote ischemic postconditioning

Experimental group

Description:

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.

Treatment:

Procedure: Remote ischemic postconditioning

control

No Intervention group

Description:

A blood cuff was around leg without inflation or deflation.