Phase 2 N=90 Randomized Quadruple-blind Treatment

A Phase II Randomized Trial of Fish Oil in Patients With Acute Lung Injury (ALI)

Respiratory Distress Syndrome, Adult · Acute Lung Injury · Acute Respiratory Distress Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00351533 ↗

Enrolled (actual)

Serious AEs

24.4%

Results posted

Oct 2011

Primary outcome: Primary: Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8 — 43; -241 pg/mL — p=0.37

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Fish oil (eicosapentaenoic acid and docosahexanoic acid) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Washington
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8	-531; -298	0.55
SECONDARY Change in BALF Leukotriene B4	0; 16	0.38
SECONDARY Change in BALF Interleukin-6	-52; -198	0.84
SECONDARY Change in BALF Monocyte Chemotactic Protein-1	-402; -670	0.74
SECONDARY Change in BALF Neutrophil Count	-4; -10	0.84
SECONDARY Static Lung Compliance	31.8; 36.3	0.26
SECONDARY Oxygenation	215.4; 174.0	0.06
SECONDARY Change in Plasma Interleukin-8	-1; 0	0.71
SECONDARY Change in Plasma Leukotriene B4	10; 6	0.08
SECONDARY Change in Plasma Interleukin-6	-83; -78	0.86
SECONDARY Change in Plasma Surfactant Protein D	26; 17	0.89
SECONDARY Change in Plasma vonWillebrand Factor	116; 43	0.34
SECONDARY Worst Multiple Organ Dysfunction Score (MODS) During First 28 Days After Study Enrollment	8.5; 8.1	0.56
SECONDARY Ventilator-free Days During First 28 Days After Study Enrollment	14.5; 13.6	0.69
SECONDARY ICU-free Days During First 28 Days After Study Enrollment	12.2; 11.2	0.66
SECONDARY Hospital Length of Stay	23; 27.6	0.27
SECONDARY Hospital Mortality	9; 10	0.65
SECONDARY 60-day Mortality	9; 11	0.49
SECONDARY Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8	-531; -298	0.55
SECONDARY Change in BALF Leukotriene B4	0; 16	0.38
SECONDARY Change in BALF Interleukin-6	-52; -198	0.84
SECONDARY Change in BALF Monocyte Chemotactic Protein-1	-402; -670	0.74
SECONDARY Change in BALF Neutrophil Count	-4; -10	0.84
SECONDARY Change in Plasma Interleukin-8	-1; 0	0.71
SECONDARY Change in Plasma Leukotriene B4	10; 6	0.08
SECONDARY Change in Plasma Interleukin-6	-83; -78	0.86
SECONDARY Change in Plasma Surfactant Protein D	26; 17	0.89
SECONDARY Change in Plasma vonWillebrand Factor	116; 43	0.34

Summary

The purpose of this study is to determine whether fish oil (containing omega-3 fatty acids) given enterally is safe and effective in reducing lung and systemic inflammation seen in acute lung injury.

Eligibility Criteria

Inclusion Criteria

Requiring positive-pressure mechanical ventilation
ALI criteria: PaO2/FiO2 17 years

Exclusion Criteria

Expected ICU length of stay 3.0
History of ventricular tachycardia or fibrillation
Receiving recombinant human activated protein C (rh-APC) for sepsis
Acquired immune deficiency syndrome (AIDS) with CD4 count < 200
Metastatic cancer
History of bone marrow, lung, liver, cardiac, kidney, or pancreas transplant

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00351533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.