NCT00881686

Brief Summary

Adenosine has been proved to be an important mediator of myocardial protection induced by ischemic preconditioning. The hypothesis of this study is that adenosine preconditioning can provide additional myocardial protection in the setting of pediatric open heart surgery with cardioplegia and cardiopulmonary bypass.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
238

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2009

Completed
Last Updated

April 15, 2009

Status Verified

March 1, 2009

Enrollment Period

6 months

First QC Date

April 14, 2009

Last Update Submit

April 14, 2009

Conditions

Heart Defects, CongenitalCardiac Surgical ProceduresMyocardial Reperfusion InjuryAdenosine

Keywords

Ischemic Preconditioning, MyocardialAdenosine

Outcome Measures

Primary Outcomes (1)

  • Outcome Measure: all cause mortality

    within the first 30 days (plus or minus 3 days) after surgery

Secondary Outcomes (1)

  • The time of ICU stay

    within the first 30 days (plus or minus 3 days) after surgery

Study Arms (1)

adenosine

EXPERIMENTAL

Adenosine will be administered intravenously before surgery

Drug: adenosine

Interventions

adenosineDRUG

1.5mg/Kg adenosine will be administered intravenously before surgery

adenosine

Eligibility Criteria

Age1 Day - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical diagnosis of congenital heart defects eligible for surgery treatment under cardiopulmonary bypass and cardioplegia
  • Body weight less than or equals to 10kg

You may not qualify if:

  • Cardiac surgery is performed without cardiopulmonary or cardioplegia
  • Body weight more than 10Kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Cardiovascular Surgery, Xijing Hospital

Xi'an, Shannxi, 710032, China

Location

MeSH Terms

Conditions

Heart Defects, CongenitalMyocardial Reperfusion Injury

Interventions

Adenosine

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCardiomyopathiesMyocardial IschemiaVascular DiseasesReperfusion InjuryPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Purine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Zhenxiao Jin, MD

    Xijing Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 14, 2009

First Posted

April 15, 2009

Study Start

June 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

April 15, 2009

Record last verified: 2009-03

Locations

CN(1)