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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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19 February 2015 |
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Main ID: |
NCT01227148 |
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Date of registration:
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15/10/2010 |
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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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Influence of Tightly Glucose Control on Hyperglycemic Toxicity and Protein Catabolism in Critically Ill Patients
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Scientific title:
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Influence of Tightly Glucose Control on Hyperglycemic Toxicity and Protein |
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Date of first enrolment:
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April 2006 |
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Target sample size:
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112 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01227148 |
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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: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Chien-Wei Hsu, 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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Kaohsiung Veterans General Hospital. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients admitted to the adult ICU who had baseline blood glucose > 180 mg/dl
- expected to require treatment in the ICU on 3 or more consecutive days.
Exclusion Criteria:
- pregnant patients
- patients with chronic renal loss (Chronic renal loss was defined as persistent
acute renal failure, complete loss of kidney function > 4 weeks)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Critically Ill Patients
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Intervention(s)
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Other: Conventional glucose control
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Other: Tightly glucose control
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Primary Outcome(s)
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24-hour urinary urea nitrogen(UUN)excretion, nitrogen balance and serum albumin and prealbumin.
[Time Frame: up to the 14th study day]
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Secondary Outcome(s)
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ICU day, ventilator day, hospital day, episodes of acute renal injury, bacteremia, blood transfusion, gastrointestinal (GI) bleeding, hypoglycemia, and hospital mortality rate.
[Time Frame: up to ICU discharge]
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Secondary ID(s)
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VGHKS95-070
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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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