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Study of Remote Ischemic Postconditioning

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01450475
First Posted: October 12, 2011
Last Update Posted: July 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
wangqiang, Xijing Hospital
  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
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Control Trial of Effect of Remote Ischemic Postconditioning on Children Undergoing Cardiac Surgery

Further study details as provided by wangqiang, Xijing Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: wangqiang, department of anesthesijology, Xijing Hospital
ClinicalTrials.gov Identifier: NCT01450475     History of Changes
Other Study ID Numbers: mazuike-18
First Submitted: October 9, 2011
First Posted: October 12, 2011
Last Update Posted: July 24, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Ischemia
Pathologic Processes