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=5 Participants	36.7 weeks STANDARD_DEVIATION 1.5 • n=7 Participants	37.0 weeks STANDARD_DEVIATION 1.3 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 weeks

Population: 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 6

Amount 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

Sanjiv Amin

University of Rochester

Phone: 585-273-2696

Email: sanjiv_amin@urmc.rochester.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place