Effect of Remote Ischemic Preconditioning on Children Undergoing Cardiac Surgery

Cyanosis Clinical Trial

Official title:

Effect of Remote Ischemic Preconditioning on Children Undergoing Cardiac Surgery: Implication of Preoperative Cyanosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01311310
• Other study ID #: H-0907-028-286
• Status: Completed
• Phase: N/A
• First received: September 20, 2009
• Last updated: April 30, 2012
• Start date: October 2009
• Est. completion date: December 2011

Study information

• Verified date: March 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is conducted in order to evaluate the effect of remote ischemic preconditioning on children undergoing cardiac surgery, especially focusing on possible differences according to preoperative cyanosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 10 Years

Eligibility

Inclusion Criteria:

• open heart surgery under cardiopulmonary bypass: ventricular septal defect, tetralogy of Fallot

Exclusion Criteria:

• chromosomal defect

• airway and parenchymal lung disease blood disorder

• isolated atrail septal defect

• immunodeficiency

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cyanosis

Intervention

Other:
• RIPC (remote ischemic preconditioning)
RIPC will be performed by four 5-min cycles of lower limb ischemia and 5 in reperfusion using blood-pressure cuff inflated to a pressure 15 mmHg greater than the systolic arterial pressure measured via arterial line.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul national university hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	troponin level	troponin level will be checked 1, 6, 12 and 24 hours after operation. Ater making a graph (troponin-time), area under the curve will bw calculated.	within the 1 day after operation	Yes