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CompletedNCT01311310Updated May 1, 2012

Effect of Remote Ischemic Preconditioning on Children Undergoing Cardiac Surgery

An interventional study of RIPC (remote ischemic preconditioning) in Cyanosis, sponsored by Seoul National University Hospital. Completed at 2 sites in Korea, Republic of. Open to participants aged 1 Month to 10 Years. Per ClinicalTrials.gov, last updated 2012-05-01.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
1 Month to 10 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cyanosis

Keywords

  • troponin, open heart surgery, children
03

In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • chromosomal defect
  • airway and parenchymal lung disease blood disorder
  • isolated atrail septal defect
  • immunodeficiency
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    remote ischemic preconditioning

    Other: RIPC (remote ischemic preconditioning)

Interventions

  • OtherRIPC (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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: within the 1 day after operation

07

Study locations

2 sites
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
  • Seoul national university hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01311310
Lead sponsor
Seoul National University Hospital
Responsible party
Jin-Tae Kim (assistant professor, Seoul National University Hospital) — Principal investigator
First posted
Mar 9, 2011
Start date
Oct 2009
Primary completion
Jul 2011
Completion
Dec 2011
Last update
May 1, 2012

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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