Study of Remote Ischemic Postconditioning

Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450475
• Other study ID #: mazuike-18
• Status: Completed
• Phase: Phase 1
• First received: October 9, 2011
• Last updated: July 22, 2013
• Start date: August 2011
• Est. completion date: October 2012

Study information

• Verified date: July 2013
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bypass Complications
• Ischemia

Intervention

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.

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cTnI,CK-MB concentration	The primary outcome is assessing whether cTnI or CK-MB concentration reduce at 24 hours after remote ischemic postconditioning.	24h after Remote Ischemic Postconditioning	No
Secondary	NSE,S100ß concentration	The secondary outcome is assessing whether NSE or S100-ß concentration reduce at 24 hours after remote ischemic postcondioning.	24 hours after Remote Ischemic Postconditioning	No