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Effect of Remote Ischemic Preconditioning on Children Undergoing Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT01311310
Recruitment Status : Completed
First Posted : March 9, 2011
Last Update Posted : May 1, 2012
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Cyanosis Other: RIPC (remote ischemic preconditioning) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Remote Ischemic Preconditioning on Children Undergoing Cardiac Surgery: Implication of Preoperative Cyanosis
Study Start Date : October 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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.




Primary Outcome Measures :
  1. troponin level [ Time Frame: within the 1 day after operation ]
    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.



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Ages Eligible for Study:   1 Month to 10 Years   (Child)
Sexes Eligible for Study:   All
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

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): NCT01311310


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

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
First Posted: March 9, 2011    Key Record Dates
Last Update Posted: May 1, 2012
Last Verified: March 2011

Keywords provided by Jin-Tae Kim, Seoul National University Hospital:
troponin, open heart surgery, children

Additional relevant MeSH terms:
Cyanosis
Signs and Symptoms