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Lipid Infusion in Dialysis Patients With Endotoxemia (LIPIDOSE)

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ClinicalTrials.gov Identifier: NCT00506454
Recruitment Status : Completed
First Posted : July 25, 2007
Results First Posted : August 15, 2011
Last Update Posted : September 20, 2011
Sponsor:
Collaborator:
The Rogosin Institute
Information provided by (Responsible Party):
Sepsicure

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
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Placebo
Hide Arm/Group Description Participants receiving the active drug. Participants receiving the placebo.
Period Title: Overall Study
Started 11 11
Completed 10 10
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
Arm/Group Title Active Placebo Total
Hide Arm/Group Description Participants receiving the active drug. Participants receiving the placebo. Total of all reporting groups
Overall Number of Baseline Participants 11 11 22
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 11 participants 22 participants
49.3  (11.57) 55.5  (7.88) 52.4  (12.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
Female
6
  54.5%
10
  90.9%
16
  72.7%
Male
5
  45.5%
1
   9.1%
6
  27.3%
1.Primary Outcome
Title Reduction in Endotoxin Levels.
Hide Description The number of participants whose post-hemodialysis endotoxin (as measured by Endotoxin Activity Assay (EAA)) was less than their pre-hemodialysis endotoxin.
Time Frame Baseline and at 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Placebo
Hide Arm/Group Description:
Participants receiving the active drug.
Participants receiving the placebo.
Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: Participants
5 5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Placebo
Hide Arm/Group Description Participants receiving the active drug. Participants receiving the placebo.
All-Cause Mortality
Active Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Active Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Active Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/11 (0.00%) 
There was no significant difference between endotoxin activity assay values in the active versus placebo recipients in this study.
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
ClinicalTrials.gov 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