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

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