Phase 2
N=22
The Effect of Remote Ischemic Preconditioning Applied in Children the Day Before Open Heart Surgery
Congenital Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT00868101 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcome: Primary: IkB-alpha Expression — 4.1; 3.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Remote ischemic preconditioning (Procedure)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Sao Paulo
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY IkB-alpha Expression |
4.1; 3.6 | — |
| PRIMARY Interleucine 8 |
20.8; 32.2 | — |
| SECONDARY NT-proBNP |
8.565; 12.681 | — |
| SECONDARY Troponin I |
33.7; 22.3 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00868101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.