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Lipid Infusion in Dialysis Patients With Endotoxemia (LIPIDOSE)

This study has been completed.
Sponsor:
Collaborator:
The Rogosin Institute
Information provided by (Responsible Party):
Sepsicure
ClinicalTrials.gov Identifier:
NCT00506454
First received: July 23, 2007
Last updated: September 16, 2011
Last verified: September 2011
History of Changes
Results First Received: June 10, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Fatigue
End Stage Renal Disease (ESRD)
Interventions: Drug: Lipidose
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Active Participants receiving the active drug.
Placebo Participants receiving the placebo.

Participant Flow:   Overall Study
    Active     Placebo  
STARTED     11     11  
COMPLETED     10     10  
NOT COMPLETED     1     1  
Withdrawal by Subject                 1                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Active Participants receiving the active drug.
Placebo Participants receiving the placebo.
Total Total of all reporting groups

Baseline Measures
    Active     Placebo     Total  
Number of Participants  
[units: participants]
 		  11     11     22  
Age  
[units: years]
Mean ± Standard Deviation 		  49.3  ± 11.57     55.5  ± 7.88     52.4  ± 12.83  
Gender  
[units: participants]
 		     
Female     6     10     16  
Male     5     1     6  



  Outcome Measures

1.  Primary:   Reduction in Endotoxin Levels.   [ Time Frame: Baseline and at 4 weeks ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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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.


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
There was no significant difference between endotoxin activity assay values in the active versus placebo recipients in this study.  


Results Point of Contact:  
Name/Title: Vice President
Organization: Sepsicure L.L.C.
phone: 212-606-4352
e-mail: bianuale@metromediacompany.com


No publications provided


Responsible Party: Sepsicure
ClinicalTrials.gov Identifier: NCT00506454     History of Changes
Other Study ID Numbers: S201
Study First Received: July 23, 2007
Results First Received: June 10, 2011
Last Updated: September 16, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board