NCT01311310

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2009

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

March 9, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 1, 2012

Status Verified

March 1, 2011

Enrollment Period

1.7 years

First QC Date

September 20, 2009

Last Update Submit

April 30, 2012

Conditions

Cyanosis

Keywords

troponin, open heart surgery, children

Outcome Measures

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.

    within the 1 day after operation

Study Arms (1)

remote ischemic preconditioning

EXPERIMENTAL
Other: RIPC (remote ischemic preconditioning)

Interventions

RIPC (remote ischemic preconditioning)OTHER

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.

remote ischemic preconditioning

Eligibility Criteria

Age1 Month - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

Seoul national university hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Cyanosis

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

September 20, 2009

First Posted

March 9, 2011

Study Start

October 1, 2009

Primary Completion

July 1, 2011

Study Completion

December 1, 2011

Last Updated

May 1, 2012

Record last verified: 2011-03

Locations

KR(2)