Background:
In this study the effect of omega-3 in the prevention of delirium will be studied.
Methods:
This study is a double blind randomized clinical trial that will be done on patients connected to the ventilator. Patients will be divided into two groups. Patients who are in the drug group will be gavage with 2 grams of omega-3 daily. In the second group will be gavage placebo. Patient medications are withheld when patients are discharged from ICU or pass 7 days of ICU admitted or Patients do not have delirium basis of Confusion assessment method for the ICU criteria two consecutive days. Primary outcomes included number of days without delirium during the first 7 days of hospitalization. Secondary outcomes included mortality during hospitalization in ICU, The number of days that patients are not connected to ventilator in the ICU stay, the number of ICU days stay. The variables collected will be compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201509055363N5
Registration date:2015-11-20, 1394/08/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-20, 1394/08/29
Registrant information
Name
Taraneh Naghibi
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3347 2865
Email address
tnaghibi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of omega-3 clinical trial in the prevention of delirium in hospitalized patients in intensive care unit
Public title
The effect of omega-3 in the prevention of delirium in intensive care unit
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: APACHEE score under 25; GCS=7-9; age over 18 years; Patients under mechanical ventilation; No history of dementia-Alzheimer and Parkinson; No use of anti-psychotic drugs; No history of allergy to omega-3 or fish; Patients who are not suffering from brain damage; Patients who were admitted due to surgical complications in the intensive care unit
Exclusion criteria: Separated from the ventilator in less than 72 hours; Death in less than 48 hours; Discharge from the ICU in under 72 hours
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
164
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Sciences
Street address
Vice- Chancellor for Research, Zanjan University of Medical Sciences, Azadi Blvd, Zanjan
City
Zanjan
Postal code
Approval date
2015-09-02, 1394/06/11
Ethics committee reference number
ZUMS.REC.1394.165
Health conditions studied
1
Description of health condition studied
delirium
ICD-10 code
F05.8
ICD-10 code description
Other delirium
Primary outcomes
1
Description
number of days without delirium during the first 7 days of hospitalization
Timepoint
Twice daily
Method of measurement
CAM-ICU: Confusion assestment method for the ICU
Secondary outcomes
1
Description
mortality during hospitalization in ICU
Timepoint
End of the study
Method of measurement
Records
2
Description
The number of days that patients are not connected to ventilator in the ICU stay
Timepoint
End of the study
Method of measurement
Records
3
Description
the number of ICU days stay
Timepoint
End of the study
Method of measurement
Records
Intervention groups
1
Description
Patients who are in the drug group will be gavage with 2 grams of omega-3 daily.
Category
Treatment - Drugs
2
Description
In the control group placebo (syrup, methyl cellulose) will be gavage.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mosavi Hospital
Full name of responsible person
Dr Taraneh Naghibi
Street address
Mosavi Hospital, Gavazang Blvd, Zanjan
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice- Chancellor for Research of Zanjan University
Full name of responsible person
Dr Faghihzadeh
Street address
Office of Vice- Chancellor for Research, Zanjan University of Medical Sciences
City
Zanjan
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 of Zanjan University
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
Zanjan University of Medical Sciences
Full name of responsible person
Navid Shafigh
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Mosavi Hospital, Gavazang Blvd, Zanjan
City
Zanjan
Postal code
Phone
+98 24 3347 2865
Fax
Email
Navid_shafigh2005@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Taraneh Naghibi
Position
ICU Fellowship- Assistant Professor
Other areas of specialty/work
Street address
Mosavi Hospital, Gavazang Blvd, Zanjan
City
Zanjan
Postal code
Phone
+98 24 3347 2865
Fax
Email
tnaghibi@zums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Faramarz Dobakhti
Position
Associated
Other areas of specialty/work
Street address
Faculty of pharmacy, Zanjan University of Medical Sciences
City
Zanjan
Postal code
Phone
+98 24 3347 2865
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)