Citrulline in Severe Sepsis



Status:Recruiting
Conditions:Hospital, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:13 - Any
Updated:4/21/2016
Start Date:August 2012

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Prospective, Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Intravenous Citrulline to Prevent or Mitigate Acute Lung Injury in Patients With 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 will decreased the development or progression of acute lung
injury in patients with severe sepsis compared to placebo.


Inclusion Criteria:

- Severe Sepsis

Exclusion Criteria:

- No Consent

- 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
We found this trial at
1
site
2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: Todd Rice, MD
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
331
mi
from 43215
Nashville, TN
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