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Citrulline in Severe Sepsis

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Todd Rice, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01474863
First received: November 11, 2011
Last updated: June 2, 2017
Last verified: June 2017
Results First Received: March 22, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions: Severe Sepsis
Acute Lung Injury
Interventions: Drug: High Dose Citrulline
Drug: Placebo
Drug: Low Dose Citrulline

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Low Dose Citrulline

Low Dose Citrulline

Low Dose Citrulline: 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.

Placebo

Placebo IV infusion

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

High Dose Citrulline

High Dose Citrulline

High Dose Citrulline: 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


Participant Flow:   Overall Study
    Low Dose Citrulline   Placebo   High Dose Citrulline
STARTED   26   22   24 
COMPLETED   26   22   24 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Low Dose Citrulline

Low Dose Citrulline

Low Dose Citrulline: 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.

Placebo

Placebo IV infusion

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

High Dose Citrulline

High Dose Citrulline

High Dose Citrulline: 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

Total Total of all reporting groups

Baseline Measures
   Low Dose Citrulline   Placebo   High Dose Citrulline   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   22   24   72 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.4  (17.1)   56.2  (16.8)   51.8  (16.6)   54.1  (16.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      10  38.5%      8  36.4%      12  50.0%      30  41.7% 
Male      16  61.5%      14  63.6%      12  50.0%      42  58.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3  11.5%      4  18.2%      2   8.3%      9  12.5% 
White      23  88.5%      18  81.8%      22  91.7%      63  87.5% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
       
United States   26   22   24   72 


  Outcome Measures

1.  Primary:   Vasopressor Dependency Index   [ Time Frame: day 4 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Todd Rice, MD
Organization: Vanderbilt University Medical Center
phone: 6153223412
e-mail: todd.rice@vanderbilt.edu



Responsible Party: Todd Rice, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01474863     History of Changes
Other Study ID Numbers: 111435
Study First Received: November 11, 2011
Results First Received: March 22, 2017
Last Updated: June 2, 2017