The effect of addition of omega-3 fatty acids on the standard treatment of critical ill patients with acute lung injury on mortality rate compared to standard treatment in intensive care unit
The objective of this study is to evaluate the effect of omega-3 fatty acids therapy on treatment of acute lung injury (ALI). After obtaining approval from the university ethics committee, 58 patients with ALI admitted in ICU will be enrolled in this study. Written consent will be obtained from all patients or their guardians. Patients with ALI will be defined as those with Pao2/Fio2<250, and lung injury whose diagnoses have been made within less than 48 hours. Patients will be randomly assigned to two groups (block randomization). In first group, patients will receive standard treatment with omega 3 capsules gavage, 6 capsules daily (2 capsules TDS) for 14 days. In second group patients will receive standard treatment. On admission and, seventh and fourteenth days, oxygenation, lung mechanics and inflammatory factors, ventilator free days, number of organ failure and neutrophil peroxidation activity will be measured and evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013020612387N1
Registration date:2013-08-28, 1392/06/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-28, 1392/06/06
Registrant information
Name
Farnaz Valiei
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1380 8451
Email address
valieif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2012-11-05, 1391/08/15
Expected recruitment end date
2013-11-06, 1392/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of addition of omega-3 fatty acids on the standard treatment of critical ill patients with acute lung injury on mortality rate compared to standard treatment in intensive care unit
Public title
The effect of omega-3 fatty acids on the treatment of acute lung injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with ALI criteria (Pao2/Fio2<250 and lung injury), less than 48 hours from their diagnosis. Exclusion criteria: Patients <18 years old, patients’ or their guardians’ unwillingness to participate, HIV, plasma TG >400, renal or liver failure, history of frequent transfusions, Thrombocytopenia (PLT<80000), Leukopenia (WBC<3000).
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This is a single-blind study. Patients are blinded to the intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz Medical University ethics committee
Street address
Golgasht St.
City
Tabriz
Postal code
5167717289
Approval date
2012-10-29, 1391/08/08
Ethics committee reference number
91150
Health conditions studied
1
Description of health condition studied
Acute lung injury
ICD-10 code
J96.0
ICD-10 code description
Acute respiratory failure
Primary outcomes
1
Description
Pao2/Fio2
Timepoint
On admission, seventh and fourteenth days
Method of measurement
Oxygenation, lung mechanic and inflammatory factors
Secondary outcomes
1
Description
Ventilator free days
Timepoint
On admission, seventh and fourteenth days
Method of measurement
Air way compliance and resistance is recorded.
2
Description
Neutrophil peroxidation activity
Timepoint
On admission, seventh and fourteenth days
Method of measurement
After performing Mini- BAL, the fluid will be centrifuged and the debris will be removed. To measure the activity of neutrophil peroxidation, a marker of lung injury, the fluid will be sent to the laboratory.
3
Description
Number of organ failure
Timepoint
On admission, seventh and fourteenth days
Method of measurement
Evaluation of various parameters such as clinical and blood serum factors.
Intervention groups
1
Description
Intervention group: Standard treatment with omega 3 capsules gavage, 6 capsules daily (2 capsules TDS) for 14 days.
Category
Treatment - Drugs
2
Description
Control group: ALI standard treatment
(low tidal volume strategy,VT:6 ml/kg)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
General ICU of Shohada Hospital
Full name of responsible person
Street address
El-goli St.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Street address
Golgasht St.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoud Parish
Position
Assistant professor of anesthesiology
Other areas of specialty/work
Street address
Shohada Hospital, El-goli St.
City
Tabriz
Postal code
Phone
+98 411385111417
Fax
Email
masoudparish@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmoodpoor
Position
Associate professor, Director of ICU
Other areas of specialty/work
Street address
General ICU, Shohada Hospital, El-goli St.
City
Tabriz
Postal code
Phone
+98 411385111417
Fax
Email
amahmoodpoor@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farnaz Valiei
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Operative room, Emam Reza Hospital, Golgasht St.
City
Tabriz
Postal code
5167717289
Phone
+98 41 1380 8451
Fax
Email
Valieif@tbzmed.ac.ir fvaliei_med@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)