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Trial record 82 of 179 for:    Phospholipids

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

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ClinicalTrials.gov Identifier: NCT01096771
Recruitment Status : Terminated (Unable to secure product from international source, low recruitment rate.)
First Posted : March 31, 2010
Results First Posted : May 26, 2014
Last Update Posted : May 26, 2014
Sponsor:
Information provided by (Responsible Party):
W. Graham Carlos, Methodist Research Institute, Indianapolis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Acute Respiratory Distress Syndrome
Interventions Drug: ClinOleic 20%
Drug: Intralipid 20%
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Experimental ClinOleic 20% Control: Intralipid 20%
Hide Arm/Group Description Patients received dietary supplement with ClinOleic 20%. Patients received dietary supplement with Intralipid 20%.
Period Title: Overall Study
Started 7 7
Completed 7 7
Not Completed 0 0
Arm/Group Title Experimental ClinOleic 20% Control: Intralipid 20% Total
Hide Arm/Group Description Patients received dietary supplement with ClinOleic 20%. Patients received dietary supplement with Intralipid 20%. Total of all reporting groups
Overall Number of Baseline Participants 7 7 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 7 participants 14 participants
64  (11.24) 60  (14.55) 62  (12.66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
Female
3
  42.9%
1
  14.3%
4
  28.6%
Male
4
  57.1%
6
  85.7%
10
  71.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
2
  28.6%
2
  14.3%
White
7
 100.0%
5
  71.4%
12
  85.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 7 participants 14 participants
7 7 14
1.Primary Outcome
Title Bronchoalveolar Lavage Fluid Interleukin-8 Concentrations
Hide Description [Not Specified]
Time Frame 96 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Experimental ClinOleic 20% Control: Intralipid 20%
Hide Arm/Group Description:
Patients received dietary supplement with ClinOleic 20%.
Patients received dietary supplement with Intralipid 20%.
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: pg/mL
1092  (1017) 544  (453.6)
2.Secondary Outcome
Title Ventilator Days
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental ClinOleic 20% Control: Intralipid 20%
Hide Arm/Group Description:
Patients received dietary supplement with ClinOleic 20%.
Patients received dietary supplement with Intralipid 20%.
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: days
18  (10.11) 18  (11.34)
3.Secondary Outcome
Title PaO2:FiO2 Ratio
Hide Description PaO2:FiO2 ratio at time of 2nd Bronchoalveolar Lavage (BAL) or end of study drug administration.
Time Frame 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental ClinOleic 20% Control: Intralipid 20%
Hide Arm/Group Description:
Patients received dietary supplement with ClinOleic 20%.
Patients received dietary supplement with Intralipid 20%.
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: mmHg
159  (60.8) 149  (78.44)
4.Secondary Outcome
Title 30 Day Mortality
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental ClinOleic 20% Control: Intralipid 20%
Hide Arm/Group Description:
Patients received dietary supplement with ClinOleic 20%.
Patients received dietary supplement with Intralipid 20%.
Overall Number of Participants Analyzed 7 7
Measure Type: Number
Unit of Measure: participants
1 1
5.Secondary Outcome
Title New Infection
Hide Description 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.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental ClinOleic 20% Control: Intralipid 20%
Hide Arm/Group Description:
Patients received dietary supplement with ClinOleic 20%.
Patients received dietary supplement with Intralipid 20%.
Overall Number of Participants Analyzed 7 7
Measure Type: Number
Unit of Measure: participants
1 0
6.Secondary Outcome
Title Organ Failures
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental ClinOleic 20% Control: Intralipid 20%
Hide Arm/Group Description:
Patients received dietary supplement with ClinOleic 20%.
Patients received dietary supplement with Intralipid 20%.
Overall Number of Participants Analyzed 7 7
Measure Type: Number
Unit of Measure: participants
1 1
7.Secondary Outcome
Title Biomarkers (C-reactive Protein)
Hide Description [Not Specified]
Time Frame 96 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental ClinOleic 20% Control: Intralipid 20%
Hide Arm/Group Description:
Patients received dietary supplement with ClinOleic 20%.
Patients received dietary supplement with Intralipid 20%.
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: mg/L
10  (9.06) 13  (13.81)
8.Secondary Outcome
Title Hospital Length of Stay
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental ClinOleic 20% Control: Intralipid 20%
Hide Arm/Group Description:
Patients received dietary supplement with ClinOleic 20%.
Patients received dietary supplement with Intralipid 20%.
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: days
22  (8.45) 28  (19.78)
9.Secondary Outcome
Title Allergic Reactions
Hide Description [Not Specified]
Time Frame 96 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental ClinOleic 20% Control: Intralipid 20%
Hide Arm/Group Description:
Patients received dietary supplement with ClinOleic 20%.
Patients received dietary supplement with Intralipid 20%.
Overall Number of Participants Analyzed 7 7
Measure Type: Number
Unit of Measure: participants
0 0
10.Secondary Outcome
Title Hypertriglyceridemia
Hide Description Defined as triglyceride level >400
Time Frame 96 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental ClinOleic 20% Control: Intralipid 20%
Hide Arm/Group Description:
Patients received dietary supplement with ClinOleic 20%.
Patients received dietary supplement with Intralipid 20%.
Overall Number of Participants Analyzed 7 7
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental ClinOleic 20% Control: Intralipid 20%
Hide Arm/Group Description Patients received dietary supplement with ClinOleic 20%. Patients received dietary supplement with Intralipid 20%.
All-Cause Mortality
Experimental ClinOleic 20% Control: Intralipid 20%
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Experimental ClinOleic 20% Control: Intralipid 20%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/7 (14.29%)      1/7 (14.29%)    
Cardiac disorders     
Death [1]  1/7 (14.29%)  1 1/7 (14.29%)  1
[1]
Patient died after study infusion drug completed. Mortality rate for ARDS is >25%. While this is a SAE it is not unexpected and could not be directly connected to study experimental or control drug.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Experimental ClinOleic 20% Control: Intralipid 20%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/7 (14.29%)      1/7 (14.29%)    
Infections and infestations     
New Infection  1/7 (14.29%)  2 0/7 (0.00%)  0
Renal and urinary disorders     
Acute Kidney Injury [1]  1/7 (14.29%)  1 1/7 (14.29%)  1
[1]
An adverse event was considered a rise in the serum creatinine level while on the study experimental or control drug.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. William Carlos
Organization: Indiana University School of Medicine
Phone: 3178807819
Responsible Party: W. Graham Carlos, Methodist Research Institute, Indianapolis
ClinicalTrials.gov Identifier: NCT01096771     History of Changes
Other Study ID Numbers: Lipids for ARDS
First Submitted: March 24, 2010
First Posted: March 31, 2010
Results First Submitted: March 26, 2014
Results First Posted: May 26, 2014
Last Update Posted: May 26, 2014