Clinical TrialID 6840

Citrulline in Severe Sepsis

NCT01474863

Severe Sepsis|Acute Lung Injury

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Record Fields

Scalar fields from the final clinical_trial record.

Clinical Trial Id
6840
Evidence Id
6840
Core Evidence Id
6840
Source Clinical Trial Id
6831
Herb2 Clinical Trial Id
HBCT006831
Nct Id
NCT01474863
Title
Citrulline in Severe Sepsis
Status
Completed
Phase
Phase 2
Study Result
Yes
Study Condition
Severe Sepsis|Acute Lung Injury
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
Intervention
DRUG: High Dose Citrulline|DRUG: Placebo|DRUG: Low Dose Citrulline
Intervention Allocation
Randomized
Intervention Model
Single_Group
Intervention Mask
Triple
Intervention Purpose
Prevention
Gender
All
Age
Child, Adult, Older_Adult
Enrollment
72
Outcome Measure
Vasopressor Dependency Index, Worst Value of Index measuring blood pressure hourly through study infusion (day 4). Vasopressor index is mean arterial blood pressure divided by catecholamine index (the catecholamine index is a dimensionless variable calculated as (dopamine dose × 1) + (dobutamine dose × 1) + (adrenaline dose × 10) + (noradrenaline × 100) + (phenylephrine dose × 100), where all doses are expressed in ug/kg/min). (Higher is better), day 4
Sponsor Collaborator
Vanderbilt University|National Institutes of Health (NIH)
Funded By
OTHER
Location
Vanderbilt University, Nashville, Tennessee, 37232, United States
Other Id
111435
Start Date
2012-08
Primary Completion Date
2016-03
Completion Date
2016-03
First Posted
2011-11-18
Results First Posted
2017-06-05
Last Update Posted
2017-06-05
Study Document
Study Url
https://clinicaltrials.gov/study/NCT01474863
Title Cn
Title En
Citrulline in Severe Sepsis
Bilingual Status
semi_complete