NCT00868101

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

January 9, 2012

Completed
Last Updated

January 9, 2012

Status Verified

December 1, 2011

Enrollment Period

1.8 years

First QC Date

March 23, 2009

Results QC Date

August 3, 2011

Last Update Submit

December 2, 2011

Conditions

Congenital Heart Disease

Keywords

ischemicpreconditioningcongenital heart disease

Outcome Measures

Primary Outcomes (2)

  • IkB-alpha Expression

    Expressure of gene of an inhibitory protein called kappa-B alpha (IkB-alpha). Inhibits the inflammatory response protein called kappa-B nuclear factor. To measure that expression we used a real time protein chain reaction (RT-PCR), always comparing with an endogenous protein expression (this way, the encountered value is apresented in "arbitraries units", that means how much times the expression of the protein IkB-alpha is bigger than the endogenous protein that present a invariable value.

    24 hours

  • Interleucine 8

    Quantification of interlecine 8 (a pro-inflammatory protein) using the ELISA method

    24 hours

Secondary Outcomes (2)

  • NT-proBNP

    24 hours

  • Troponin I

    24 hours

Study Arms (2)

Preconditioning

EXPERIMENTAL

Children who received the preconditioning stimulus

Procedure: Remote ischemic preconditioning

Control

NO INTERVENTION

Children who did not receive the preconditioning stimulus

Interventions

Remote ischemic preconditioningPROCEDURE

Remote ischemic preconditioning was induced by four 5-minutes cycles of lower limb ischemia and reperfusion using a blood pressure cuff

Also known as: Inicial letters of the full name, Register number provided by hospital
Preconditioning

Eligibility Criteria

Age1 Month - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Ribeirao Preto, Sao Paulo University

Ribeirão Preto, São Paulo, 55, Brazil

Location

MeSH Terms

Conditions

Heart Defects, CongenitalIschemia

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

Small number of subjects

Results Point of Contact

Title
Marcos Alves Pavione
Organization
Universidade de Sao Paulo
mapavione@hotmail.com
55 79 9199 9576

Study Officials

  • Ana Paula CP Carlotti, 1

    University of Sao Paulo

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
mester

Study Record Dates

First Submitted

March 23, 2009

First Posted

March 24, 2009

Study Start

January 1, 2008

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

January 9, 2012

Results First Posted

January 9, 2012

Record last verified: 2011-12

Locations

BR(1)