The Effect of Remote Ischemic Preconditioning Applied in Children the Day Before Open Heart Surgery

U

University of Sao Paulo

Status and phase

Completed
Phase 2
Phase 1

Conditions

Congenital Heart Disease

Treatments

Procedure: Remote ischemic preconditioning

Study type

Interventional

Funder types

Other

Identifiers

NCT00868101
MAP01

Details and patient eligibility

About

The study research is to analyse brief episodes of limb ischemia applied to children the day before open heart surgery as protection from myocardial injury induced by extracorporeal circulation.

Full description

Children undergoing repair of congenital heart defects were randomized to RIPC (remote ischemic preconditioning) or control treatment. RIPC was induced by four 5-minutes cycles of lower limb ischemia and reperfusion using a blood pressure cuff. Measurements of troponin I, brain natriuretic peptide, interleukines 8 and 10, real time PCR to NFKB and clinical parameters were obtained and compared postoperatively (4, 12, 24 and 48 hous after).

Enrollment

22 patients

Sex

All

Ages

1 month to 2 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 1 month to 2 years age
  • waiting for open heart surgery in hospital
  • 2008, january to march
  • Rachs-1, except the 1 category

Exclusion criteria

  • genetic syndromes
  • infected children
  • immunodeficiency
  • immunosuppressor use
  • no parents permission

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

22 participants in 2 patient groups

Preconditioning
Experimental group
Description:
Children who received the preconditioning stimulus
Treatment:
Procedure: Remote ischemic preconditioning
Control
No Intervention group
Description:
Children who did not receive the preconditioning stimulus

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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