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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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16 December 2017 |
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Main ID: |
NCT02599155 |
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Date of registration:
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03/11/2015 |
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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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The Effect of the Hydroxyethyl Starch on Kidney Injury in Pediatric Cardiac Surgery
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Scientific title:
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The Effect of the Hydroxyethyl Starch on Kidney Injury in Pediatric Cardiac Surgery |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02599155 |
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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: Prevention. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Jin-Tae Kim, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Seoul National University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children aged less than 7 years old
- American Society of Anesthesiology (ASA) physical status 1-3
Exclusion Criteria:
- Preoperative creatinine > 1.5mg/dl
- History of dialysis
- Liver function abnormality
- Diabetes Mellitus
- History of allergic reaction
- Coagulation abnormality
Age minimum:
N/A
Age maximum:
7 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Acute Kidney Injury
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Intervention(s)
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Drug: Colloid
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Drug: Crystalloid
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Primary Outcome(s)
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Acute Kidney Injury
[Time Frame: From the day of surgery to postoperative 7 days]
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Secondary Outcome(s)
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Length of ICU stay
[Time Frame: From the day of surgery to postoperative 7 days]
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Transfusion amount
[Time Frame: From the day of surgery to postoperative 7 days]
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Blood loss
[Time Frame: From the day of surgery to postoperative 7 days]
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Mechanical ventilation time
[Time Frame: From the day of surgery to postoperative 7 days]
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Secondary ID(s)
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H1507-061-687
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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