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Completed

NCT Number: NCT01450475

Study of Remote Ischemic Postconditioning

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.

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Key information

Conditions

Ischemia Bypass Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Xijing Hospital

Xi'an, Shaanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote ischemic postconditioning

Procedure

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

Primary outcomes

  1. cTnI,CK-MB concentration

    Time frame: 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 outcomes

  1. NSE，S100β concentration

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 12, 2011
Registry last updated
Jul 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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