Lipid Infusion in Dialysis Patients With Endotoxemia (LIPIDOSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00506454
Recruitment Status : Completed
First Posted : July 25, 2007
Results First Posted : August 15, 2011
Last Update Posted : September 20, 2011
The Rogosin Institute
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Fatigue
End Stage Renal Disease (ESRD)
Interventions: Drug: Lipidose
Drug: Placebo

  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
Active Participants receiving the active drug.
Placebo Participants receiving the placebo.

Participant Flow:   Overall Study
    Active   Placebo
STARTED   11   11 
COMPLETED   10   10 
Withdrawal by Subject                1                1 

  Baseline Characteristics

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
Active Participants receiving the active drug.
Placebo Participants receiving the placebo.
Total Total of all reporting groups

Baseline Measures
   Active   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   11   22 
[Units: Years]
Mean (Standard Deviation)
 49.3  (11.57)   55.5  (7.88)   52.4  (12.83) 
[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 ]

  Serious Adverse Events

  Other Adverse Events

  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.

  More Information

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: Vice President
Organization: Sepsicure L.L.C.
phone: 212-606-4352

Responsible Party: Sepsicure Identifier: NCT00506454     History of Changes
Other Study ID Numbers: S201
First Submitted: July 23, 2007
First Posted: July 25, 2007
Results First Submitted: June 10, 2011
Results First Posted: August 15, 2011
Last Update Posted: September 20, 2011