Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2012-08-31
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
TRIPLE
Study Groups
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Low Dose Citrulline
Low Dose Citrulline
Low Dose Citrulline
Initial intravenous bolus of 10mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 4.5mg/kg (max 350mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days.
Placebo
Placebo IV infusion
Placebo
D5W IV fluids at isovolumetric rate (about 15ml/hr)
High Dose Citrulline
High Dose Citrulline
High Dose Citrulline
Initial intravenous bolus of 20mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 9mg/kg (max 700mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days
Interventions
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High Dose Citrulline
Initial intravenous bolus of 20mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 9mg/kg (max 700mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days
Placebo
D5W IV fluids at isovolumetric rate (about 15ml/hr)
Low Dose Citrulline
Initial intravenous bolus of 10mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 4.5mg/kg (max 350mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Malignant or other irreversible condition
* Moribund and not expected to survive 48 hours
* End Stage Liver Disease
* Enrolled in another IND study
* Pregnant or breast feeding female
* Age\<13 years old
* Allergy to citrulline or arginine
13 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
Vanderbilt University
OTHER
Responsible Party
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Todd Rice
Assistant Professor of Medicine
Principal Investigators
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Todd Rice, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Vanderbilt University
Nashville, Tennessee, United States
Countries
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Other Identifiers
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111435
Identifier Type: -
Identifier Source: org_study_id
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