Study of Remote Ischemic Postconditioning

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
wangqiang, Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01450475
First received: October 9, 2011
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Ischemia
Bypass Complications
Procedure: Remote ischemic postconditioning
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Control Trial of Effect of Remote Ischemic Postconditioning on Children Undergoing Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • cTnI,CK-MB concentration [ Time Frame: 24h after Remote Ischemic Postconditioning ] [ Designated as safety issue: No ]
    The primary outcome is assessing whether cTnI or CK-MB concentration reduce at 24 hours after remote ischemic postconditioning.


Secondary Outcome Measures:
  • NSE,S100β concentration [ Time Frame: 24 hours after Remote Ischemic Postconditioning ] [ Designated as safety issue: No ]
    The secondary outcome is assessing whether NSE or S100-β concentration reduce at 24 hours after remote ischemic postcondioning.


Enrollment: 65
Study Start Date: August 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Limb ischemic postconditioning
No Intervention: control
A blood cuff was around leg without inflation or deflation.

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.

  Eligibility

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450475

Locations
China, Shaanxi
Xijing Hospital
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
Investigators
Study Director: Wang Qiang, doctor Xijing Hospital
  More Information

No publications provided

Responsible Party: wangqiang, department of anesthesijology, Xijing Hospital
ClinicalTrials.gov Identifier: NCT01450475     History of Changes
Other Study ID Numbers: mazuike-18
Study First Received: October 9, 2011
Last Updated: July 22, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014