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Main
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Note: This record shows only the 20 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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21 January 2013 |
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Main ID: |
NCT01382758 |
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Date of registration:
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15/06/2011 |
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Primary sponsor: |
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Public title:
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Near Infrared Spectroscopy for the Detection of Acute Kidney Injury in Children Following Cardiac Surgery
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Scientific title:
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Use of Near Infrared Spectroscopy (NIRS) for the Early Detection of Acute Kidney Injury in Children Post Cardiopulmonary Bypass |
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Date of first enrolment:
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July 2011 |
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Target sample size:
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107 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01382758 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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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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Katja Gist, DO |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital Colorado |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All children less than or equal to age 4 undergoing cardiac surgery with the use of
cardiopulmonary bypass at Colorado Children's Hospital
Exclusion Criteria:
- Prior enrollment in the study
- Agre greater than 4 years
- Use of nephrotoxic drugs within 48 hours of surgery
- Underlying renal dysfunction (preoperative estimated Schwartz clearance less than
80ml/min/1.73m2)
- Gestational age less than 34 weeks at the time of surgery
- Withdrawal of care planned
Age minimum:
N/A
Age maximum:
4 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Kidney Injury
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Children
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Heart; Dysfunction Postoperative, Cardiac Surgery
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Primary Outcome(s)
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Acute kidney injury
[Time Frame: 48-72 hours]
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Secondary Outcome(s)
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30-day mortality and AKI
[Time Frame: 30 days]
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Acute kidney injury by renal biomarkers
[Time Frame: 12 hours]
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Hospital length of stay and AKI
[Time Frame: An average of 1 week for simple defects and 4 weeks for complex congenital heart defects (Hypoplastic left heart syndrome)]
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Mechanical ventilation and acute kidney injury
[Time Frame: Hospital admission (day 1)]
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Secondary ID(s)
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11-0527
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AAP11-0527
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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