Trial Outcomes & Findings for Lipid Infusion in Dialysis Patients With Endotoxemia (NCT NCT00506454)

Results Overview

The number of participants whose post-hemodialysis endotoxin (as measured by Endotoxin Activity Assay (EAA)) was less than their pre-hemodialysis endotoxin.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

Baseline and at 4 weeks

Results posted on

2011-09-20

Participant Flow

Participant milestones

Participant milestones
Measure	Active Participants receiving the active drug.	Placebo Participants receiving the placebo.
Overall Study STARTED	11	11
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Participants receiving the active drug.	Placebo Participants receiving the placebo.
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Lipid Infusion in Dialysis Patients With Endotoxemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active n=11 Participants Participants receiving the active drug.	Placebo n=11 Participants Participants receiving the placebo.	Total n=22 Participants Total of all reporting groups
Age Continuous	49.3 years STANDARD_DEVIATION 11.57 • n=5 Participants	55.5 years STANDARD_DEVIATION 7.88 • n=7 Participants	52.4 years STANDARD_DEVIATION 12.83 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and at 4 weeks

The number of participants whose post-hemodialysis endotoxin (as measured by Endotoxin Activity Assay (EAA)) was less than their pre-hemodialysis endotoxin.

Outcome measures

Outcome measures
Measure	Treatment n=10 Participants Participants receiving the active drug.	Placebo n=10 Participants Participants receiving the placebo.
Reduction in Endotoxin Levels.	5 Participants	5 Participants

Adverse Events

Active

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vice President

Sepsicure L.L.C.

Phone: 212-606-4352

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place