Who is sponsoring NCT01474863?

NCT01474863 is sponsored by Vanderbilt University.

What condition does NCT01474863 study?

NCT01474863 studies Severe Sepsis, Acute Lung Injury.

What drugs are being tested in NCT01474863?

Interventions: High Dose Citrulline, Placebo, Low Dose Citrulline.

What is the status of NCT01474863?

NCT01474863 is currently COMPLETED.

Last reviewed 2017-06-02 · How we verify

Prospective, Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Intravenous Citrulline to Prevent or Mitigate Acute Lung Injury in Patients With Severe Sepsis

NCT01474863 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Vanderbilt University
Phase	Phase 2
Status	COMPLETED
Enrolment	72
Start date	2012-08
Completion	2016-03

Conditions

Severe Sepsis
Acute Lung Injury

Interventions

High Dose Citrulline
Placebo
Low Dose Citrulline

Primary outcomes

Vasopressor Dependency Index — day 4
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)

Countries

United States