Trial Outcomes & Findings for Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis (NCT NCT01555957)
NCT ID: NCT01555957
Last Updated: 2020-12-03
Results Overview
Defined as direct bilirubin ≥ 2mg/dl developing within one week of the completion of 6 week randomization period
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
40 participants
Primary outcome timeframe
7 weeks
Results posted on
2020-12-03
Participant Flow
Participant milestones
| Measure |
Low Dose Intravenous Lipids
intravenous lipid: intravenous given daily for 6 weeks
|
High Dose of Intravenous Lipids
intravenous lipid: intravenous given daily for 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis
Baseline characteristics by cohort
| Measure |
Low Dose Intravenous Lipids
n=20 Participants
intravenous lipid: intravenous given daily for 6 weeks
|
High Dose of Intravenous Lipids
n=20 Participants
intravenous lipid: intravenous given daily for 6 weeks
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.9 weeks
STANDARD_DEVIATION 1.1 • n=99 Participants
|
36.7 weeks
STANDARD_DEVIATION 1.5 • n=107 Participants
|
37.0 weeks
STANDARD_DEVIATION 1.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
20 participants
n=107 Participants
|
40 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 7 weeksPopulation: Intent to treat analysis
Defined as direct bilirubin ≥ 2mg/dl developing within one week of the completion of 6 week randomization period
Outcome measures
| Measure |
Low Dose Intravenous Lipids
n=20 Participants
intravenous lipid: intravenous given daily for 6 weeks
|
High Dose of Intravenous Lipids
n=20 Participants
intravenous lipid: intravenous given daily for 6 weeks
|
|---|---|---|
|
Number of Participants With Parenteral Nutrition Associated Cholestasis
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: baseline, weeks 1, 2, 3, 4, 5 and 6Amount of direct (conjugated) bilirubin was measured from sera samples.
Outcome measures
| Measure |
Low Dose Intravenous Lipids
n=20 Participants
intravenous lipid: intravenous given daily for 6 weeks
|
High Dose of Intravenous Lipids
n=20 Participants
intravenous lipid: intravenous given daily for 6 weeks
|
|---|---|---|
|
Mean Rate of Change in Direct Bilirubin
|
0.16 mg/dL/week
Interval 0.03 to 0.28
|
0.19 mg/dL/week
Interval 0.06 to 0.32
|
Adverse Events
Low Dose Intravenous Lipids
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Dose of Intravenous Lipids
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose Intravenous Lipids
n=20 participants at risk
intravenous lipid: intravenous given daily for 6 weeks
|
High Dose of Intravenous Lipids
n=20 participants at risk
intravenous lipid: intravenous given daily for 6 weeks
|
|---|---|---|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/20 • 42 days
|
0.00%
0/20 • 42 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place