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OpenTrials
Completed

NCT Number: NCT01474863

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 will decreased the development or progression of acute lung injury in patients with severe sepsis compared to placebo.

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Key information

Conditions

Severe Sepsis Acute Lung Injury Infections Inflammation Lung Diseases Lung Injury Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Sepsis Systemic Inflammatory Response Syndrome

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Dose Citrulline

Drug

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

Drug

D5W IV fluids at isovolumetric rate (about 15ml/hr)

Low Dose Citrulline

Drug

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.

Primary outcomes

  1. Vasopressor Dependency Index

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 18, 2011
Registry last updated
Jun 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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