Effect of Remote Ischemic Preconditioning on Children Undergoing Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01311310
First received: September 20, 2009
Last updated: April 30, 2012
Last verified: March 2011
  Purpose

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.


Condition Intervention
Cyanosis
Other: RIPC (remote ischemic preconditioning)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Remote Ischemic Preconditioning on Children Undergoing Cardiac Surgery: Implication of Preoperative Cyanosis

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • troponin level [ Time Frame: within the 1 day after operation ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 60
Study Start Date: October 2009
Study Completion Date: December 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   1 Month to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01311310

Locations
Korea, Republic of
Seoul national university hospital
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Jin-Tae Kim, assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01311310     History of Changes
Other Study ID Numbers: H-0907-028-286
Study First Received: September 20, 2009
Last Updated: April 30, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
troponin, open heart surgery, children

Additional relevant MeSH terms:
Cyanosis
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014