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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00848393 |
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Date of registration:
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19/02/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Measures to Lower the Stress Response in Pediatric Cardiac Surgery
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Scientific title:
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Stress Response in Children Undergoing Cardiac Surgery: a Prospective Randomized Comparison Between Low Dose Fentanyl (LDF), Low Dose Fentanyl Plus Dexmedetomidine (LDF + Dex) and High Dose Fentanyl (HDF). |
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Date of first enrolment:
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November 2008 |
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Target sample size:
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52 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00848393 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Aymen N Naguib, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nationwide Children's Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Childrens with the diagnosis of tetralogy of fallot, ventricular septal defect and
atrioventricular septal defect who are under one year of age.
Exclusion Criteria:
- Patients who are having reoperation.
- Patients with comorbidities, such as heart failure.
- Patients receiving digoxin preoperatively.
Age minimum:
1 Month
Age maximum:
3 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Tetralogy of Fallot (TOF)
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Atrioventricular Septal Defects (AVSD)
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Ventricular Septal Defects (VSD)
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Intervention(s)
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Drug: Fentanyl (Low Dose)
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Drug: Fentanyl (High Dose)
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Drug: Fentanyl (Low Dose) + Dexmedetomidine
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Primary Outcome(s)
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Stress Hormone Levels
[Time Frame: Blood draws to measure stress hormone levels within one hour of draw: after induction; after sternotomy; after starting cardiopulmonary bypass; at the end of the procedure; and 24 hours after the procedure.]
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ACTH and Cytokine Levels
[Time Frame: Blood draws to measure cytokines levels within one hour of draw: after induction; after sternotomy; after starting cardiopulmonary bypass; at the end of the procedure; and 24 hours after the procedure.]
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Comparisons Between Groups for Narcotic and/or Dexmedetomidine Intervention Influence on Length of CTICU Stay.
[Time Frame: Hospital admission to discharge from CTICU (average of 2-4 days)]
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Stanford-Binet Intelligence Scales
[Time Frame: 1-4 yrs. post-surgery]
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Comparisons Between Groups for Narcotic and/or Dexmedetomidine Intervention Influence on Time on Ventilator.
[Time Frame: Time of intubation to extubation (variable)]
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Secondary Outcome(s)
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Stanford-Binet Cognitive Ability
[Time Frame: 1-4 yrs post-surgery]
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ABAS-II
[Time Frame: 1-4 yrs post-surgery]
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Secondary ID(s)
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IRB08-00029
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101911
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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