Trial Outcomes & Findings for The Effect of Intravenous Lipids on Lung Function in Acute Respiratory Distress Syndrome (ARDS) (NCT NCT01096771)

NCT ID: NCT01096771

Last Updated: 2014-05-26

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 14 participants
• Primary outcome timeframe: 96 hours
• Results posted on: 2014-05-26

Participant Flow

Participant milestones

Measure	Experimental ClinOleic 20% Patients received dietary supplement with ClinOleic 20%.	Control: Intralipid 20% Patients received dietary supplement with Intralipid 20%.
Overall Study STARTED	7	7
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Intravenous Lipids on Lung Function in Acute Respiratory Distress Syndrome (ARDS)

Baseline characteristics by cohort

Measure	Experimental ClinOleic 20% n=7 Participants Patients received dietary supplement with ClinOleic 20%.	Control: Intralipid 20% n=7 Participants Patients received dietary supplement with Intralipid 20%.	Total n=14 Participants Total of all reporting groups
Age, Continuous	64 years STANDARD_DEVIATION 11.24 • n=93 Participants	60 years STANDARD_DEVIATION 14.55 • n=4 Participants	62 years STANDARD_DEVIATION 12.66 • n=27 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	6 Participants n=4 Participants	10 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) White	7 Participants n=93 Participants	5 Participants n=4 Participants	12 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	7 participants n=93 Participants	7 participants n=4 Participants	14 participants n=27 Participants

PRIMARY outcome

Timeframe: 96 hours

Population: Each arm has one less subject than specified in the participate flow module. One is secondary to the fact that the subject refused the 2nd bronchoscopy and the other is because the primary physician felt the subject was too sick to undergo the 2nd bronchscopy.

Outcome measures

Measure	Experimental ClinOleic 20% n=6 Participants Patients received dietary supplement with ClinOleic 20%.	Control: Intralipid 20% n=6 Participants Patients received dietary supplement with Intralipid 20%.
Bronchoalveolar Lavage Fluid Interleukin-8 Concentrations	1092 pg/mL Standard Deviation 1017	544 pg/mL Standard Deviation 453.6

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	Experimental ClinOleic 20% n=7 Participants Patients received dietary supplement with ClinOleic 20%.	Control: Intralipid 20% n=7 Participants Patients received dietary supplement with Intralipid 20%.
Ventilator Days	18 days Standard Deviation 10.11	18 days Standard Deviation 11.34

SECONDARY outcome

Timeframe: 4 days

PaO2:FiO2 ratio at time of 2nd Bronchoalveolar Lavage (BAL) or end of study drug administration.

Outcome measures

Measure	Experimental ClinOleic 20% n=7 Participants Patients received dietary supplement with ClinOleic 20%.	Control: Intralipid 20% n=7 Participants Patients received dietary supplement with Intralipid 20%.
PaO2:FiO2 Ratio	159 mmHg Standard Deviation 60.8	149 mmHg Standard Deviation 78.44

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	Experimental ClinOleic 20% n=7 Participants Patients received dietary supplement with ClinOleic 20%.	Control: Intralipid 20% n=7 Participants Patients received dietary supplement with Intralipid 20%.
30 Day Mortality	1 participants	1 participants

SECONDARY outcome

Timeframe: 30 days

We will use standard clinical criteria including but not limited to: fever, pyuria, new inflitrate on chest x-ray, positive blood cultures, abscess detected on imaging, leukocytosis, and positive skin or soft-tissue cultures to identify presence of new bacterial infections occurring after enrollment.

Outcome measures

Measure	Experimental ClinOleic 20% n=7 Participants Patients received dietary supplement with ClinOleic 20%.	Control: Intralipid 20% n=7 Participants Patients received dietary supplement with Intralipid 20%.
New Infection	1 participants	0 participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	Experimental ClinOleic 20% n=7 Participants Patients received dietary supplement with ClinOleic 20%.	Control: Intralipid 20% n=7 Participants Patients received dietary supplement with Intralipid 20%.
Organ Failures	1 participants	1 participants

SECONDARY outcome

Timeframe: 96 hours

Outcome measures

Measure	Experimental ClinOleic 20% n=7 Participants Patients received dietary supplement with ClinOleic 20%.	Control: Intralipid 20% n=7 Participants Patients received dietary supplement with Intralipid 20%.
Biomarkers (C-reactive Protein)	10 mg/L Standard Deviation 9.06	13 mg/L Standard Deviation 13.81

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	Experimental ClinOleic 20% n=7 Participants Patients received dietary supplement with ClinOleic 20%.	Control: Intralipid 20% n=7 Participants Patients received dietary supplement with Intralipid 20%.
Hospital Length of Stay	22 days Standard Deviation 8.45	28 days Standard Deviation 19.78

SECONDARY outcome

Timeframe: 96 hours

Outcome measures

Measure	Experimental ClinOleic 20% n=7 Participants Patients received dietary supplement with ClinOleic 20%.	Control: Intralipid 20% n=7 Participants Patients received dietary supplement with Intralipid 20%.
Allergic Reactions	0 participants	0 participants

SECONDARY outcome

Timeframe: 96 hours

Defined as triglyceride level >400

Outcome measures

Measure	Experimental ClinOleic 20% n=7 Participants Patients received dietary supplement with ClinOleic 20%.	Control: Intralipid 20% n=7 Participants Patients received dietary supplement with Intralipid 20%.
Hypertriglyceridemia	0 participants	0 participants

Adverse Events

Experimental ClinOleic 20%

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Control: Intralipid 20%

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Experimental ClinOleic 20% n=7 participants at risk Patients received dietary supplement with ClinOleic 20%.	Control: Intralipid 20% n=7 participants at risk Patients received dietary supplement with Intralipid 20%.
Cardiac disorders Death	14.3% 1/7 • Number of events 1	14.3% 1/7 • Number of events 1

Other adverse events

Measure	Experimental ClinOleic 20% n=7 participants at risk Patients received dietary supplement with ClinOleic 20%.	Control: Intralipid 20% n=7 participants at risk Patients received dietary supplement with Intralipid 20%.
Renal and urinary disorders Acute Kidney Injury	14.3% 1/7 • Number of events 1	14.3% 1/7 • Number of events 1
Infections and infestations New Infection	14.3% 1/7 • Number of events 2	0.00% 0/7

Additional Information

Dr. William Carlos

Indiana University School of Medicine

Phone: 3178807819

Email: wcarlos@iu.edu

Results disclosure agreements

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