Effect of Remote Ischemic Preconditioning on Children Undergoing Cardiac Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Cyanosis
• Intervention / Treatment: Other: RIPC (remote ischemic preconditioning)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: remote ischemic preconditioning	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: September 20, 2009
• First Submitted That Met QC Criteria: March 6, 2011
• First Posted (Estimate): March 9, 2011

Study Record Updates

• Last Update Posted (Estimate): May 1, 2012
• Last Update Submitted That Met QC Criteria: April 30, 2012
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: troponin, open heart surgery, children
• Additional Relevant MeSH Terms: Cyanosis
• Other Study ID Numbers: H-0907-028-286