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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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17 October 2012 |
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Main ID: |
NCT01398722 |
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Date of registration:
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11/07/2011 |
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Primary sponsor: |
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Public title:
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Effect of Intensive Insulin Therapy on Clinical Prognosis of Infants Undergoing Cardiac Surgery
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Scientific title:
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Study of the Relationship Between Intensive Insulin Therapy and Clinical Prognosis in Infants Undergoing Cardiac Surgery |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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800 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01398722 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Countries of recruitment
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China
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Contacts
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Name:
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Chunhu Gu, MD |
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Address:
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Telephone:
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Email:
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guchunhu@fmmu.edu.cn |
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Affiliation:
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Name:
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Chunhu Gu, MD |
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Address:
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Telephone:
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Email:
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guchunhu@fmmu.edu.cn |
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Affiliation:
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Name:
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Dinhhua Yi, 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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Xijing Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Infants underwent cardiac surgery with cardiopulmonary bypass
Exclusion Criteria:
- Therapy restricted upon admission
- Preoperative liver or kidney disease or dysfunction
- Preoperative coagulation disorder
- Palliative operation or a second operation
- Type 1 diabetes
- Type 2 diabetes
Age minimum:
N/A
Age maximum:
3 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cardiac Surgery
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Intervention(s)
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Other: Conventional insulin therapy
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Other: Intensive insulin therapy
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Primary Outcome(s)
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All cause mortality
[Time Frame: one year]
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Secondary Outcome(s)
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Acute renal failure
[Time Frame: average 1 month during the hospitalization]
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Biochemical markers of myocardial injury(troponin and creatine kinase MB)
[Time Frame: average 1 month during the hospitalization]
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Cardiac Index
[Time Frame: average 1 month during the hospitalization]
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ICU and hospital length of stay, and ICU readmissions
[Time Frame: average 1 month during the hospitalization]
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Inotropic Scores
[Time Frame: average 1 month during the hospitalization]
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Perioperative complications
[Time Frame: average 1 month during the hospitalization]
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Respiratory failure
[Time Frame: average 1 month during the hospitalization]
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Stroke and reversible ischemic neurologic deficit
[Time Frame: average 1 month during the hospitalization]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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