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NCT01474863 · ClinicalTrials.gov registry record · Phase 2
Citrulline in Severe Sepsis
A Phase 2 study, sponsored by Vanderbilt University.
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
NCT01474863: Completed Phase 2 study, sponsored by Vanderbilt University.
NCT01474863 is a Phase 2 study that has completed, run by Vanderbilt University. The registered enrollment target is 72 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01474863, a Phase 2 study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled, phase 2 study to evaluate biochemical, clinical, and safety effects of 2 doses of intravenous L-citrulline compared to placebo in patients with severe sepsis at risk for or with acute lung injury. The hypothesis is that intravenous L-citrulline will decreased the development or progression of acute lung injury in patients with severe sepsis compared to placebo.
Primary Outcome
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)
Interventions
- DRUG Placebo
- DRUG High Dose Citrulline
- DRUG Low Dose Citrulline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2012-08 |
| Est. Completion | 2016-03 |
| Phase | Phase 2 |
What the finished NCT01474863 record still lists
NCT01474863 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01474863 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01474863 about?
NCT01474863 is a clinical study titled "Citrulline in Severe Sepsis". This is a randomized, double-blind, placebo-controlled, phase 2 study to evaluate biochemical, clinical, and safety effects of 2 doses of intravenous L-citrulline compared to placebo in patients with severe sepsis at risk for or with acute lung injury. The hypothesis is that intravenous L-citrulline...
What is the current status of trial NCT01474863?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2012-08. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01474863?
The interventions under investigation include: Placebo (DRUG), High Dose Citrulline (DRUG), Low Dose Citrulline (DRUG).
Who is sponsoring clinical trial NCT01474863?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01474863's enrollment target sits among peer trials
72 925th of 2000 higher than 1,065 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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