Trial Outcomes & Findings for L-Carnitine in Peritoneal Dialysis (NCT NCT00922701)
NCT ID: NCT00922701
Last Updated: 2010-02-23
Results Overview
The amount of fluid recovered from the peritoneum at the end of the nocturnal exchange (long dwell) with a peritoneal dialysis solution.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
day 5
Results posted on
2010-02-23
Participant Flow
From June, 2004, to November, 2004. Medical Clinic
One-week run-in
Participant milestones
| Measure |
Peritoneal Dialysis Solution
Patients were treated with a glucose-based (1.5% weight/volume) peritoneal dialysis solution containing L-carnitine (0.25% weight/volume) for the long dwell. Peritoneal dialysis solution was instilled for 5 days.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
L-Carnitine in Peritoneal Dialysis
Baseline characteristics by cohort
| Measure |
Peritoneal Dialysis Solution
n=4 Participants
The enrolled patients were using for the long dwell (nocturnal) exchange a glucose-based (2.5% w/v) peritoneal dialysis solution.
|
|---|---|
|
Age Continuous
|
61.6 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
4 participants
n=5 Participants
|
|
Ultrafiltration
|
1987 milliliters
STANDARD_DEVIATION 192 • n=5 Participants
|
PRIMARY outcome
Timeframe: day 5The amount of fluid recovered from the peritoneum at the end of the nocturnal exchange (long dwell) with a peritoneal dialysis solution.
Outcome measures
| Measure |
Peritoneal Dialysis Solution
n=4 Participants
Patients were treated with a glucose-based (1.5% weight/volume) peritoneal dialysis solution containing L-carnitine (0.25% weight/volume) for the long dwell. Peritoneal dialysis solution was instilled for 5 days.
|
|---|---|
|
Long Dwell Ultrafiltration
|
2167 milliliters
Standard Deviation 203
|
Adverse Events
Peritoneal Dialysis Solution
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place