Increasing Reactive oxygen and nitrogen production occurred simultaneously with decreasing serum and intracellular level of antioxidants and enzymes in critical ill patients, which result in increasing ventilator dependency and length of stay in intensive care unit and it also accelerate organ failures in patients. In this double blind clinical trial, we examine effect of alfa-lipoic acid on those patients who admitted to intensive care unit that we expect to stay for more than 7 days in this ward and who have tube feeding and don’t have severe liver and kidney failure, AIDS and hepatitis. After randomization of included patients by block randomization we will give 900mg/day alfa-lipoic acid for ten days to treatment group and identical placebo to control group by naso-gastric tube. The purposes of this study are decreasing ventilator dependency period, length of stay in ICU, mortality and decelerate of organ failures.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201302083236N4
Registration date:2013-06-06, 1392/03/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-06, 1392/03/16
Registrant information
Name
Zohreh Mazloom
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1008
Email address
zmazloom@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences (SUMS)
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of alfa lipoic acid on biochemical and nutritional status and important outcomes in patients admitted to intensive care unit.
Public title
Effect of alfa-lipoic acid on important outcomes in patients admitted to intensive care units
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age≥18; expected length of stay more than 7 days; using enteral feeding method during admitted to ICU. Exclusion criteria: having the history of autoimmune disease, severe renal or liver failure, AIDS, hepatitis; having severe malnutrition at the admission time; having TPN at the admission time in ICU; extreme intolerance to enteral feeding.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
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
shiraz university of medical sciences
Street address
iran, fars, shiraz,shiraz university of medical sciences
City
shiraz
Postal code
Approval date
2013-01-26, 1391/11/07
Ethics committee reference number
91-6423
Health conditions studied
1
Description of health condition studied
patients admitted in Intensive Care Unit
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
length of stay in ICU
Timepoint
at the end
Method of measurement
days
2
Description
mortality
Timepoint
at the end
Method of measurement
number and percent
3
Description
ventilator free days
Timepoint
during ICU stay
Method of measurement
daily assessment
Secondary outcomes
1
Description
sequential organ failure assessment score
Timepoint
first and last days of intervention
Method of measurement
sequential organ failure assessment score questioniar
2
Description
insulin resistance
Timepoint
first and last days of intervention
Method of measurement
HOMA calculation equation
3
Description
malondialdehyde
Timepoint
first and last days of intervention
Method of measurement
spectrophotometery
4
Description
total antioxidant capacity
Timepoint
first and last days of intervention
Method of measurement
ELIZA
5
Description
C reactive protein
Timepoint
first and last days of intervention
Method of measurement
nephelometry
6
Description
interleukin-6
Timepoint
first and last days of intervention
Method of measurement
ELIZA
7
Description
Albumin
Timepoint
first and last days of intervention
Method of measurement
ELIZA
8
Description
preAlbumin
Timepoint
first and last days of intervention
Method of measurement
Turbidimetry
9
Description
Total lymphocyte count
Timepoint
first and last days of intervention
Method of measurement
microscopic count
10
Description
Mid arm circumference
Timepoint
first and last days of intervention
Method of measurement
centimeter
11
Description
total protein
Timepoint
first and last days of intervention
Method of measurement
based on labratory measurement
Intervention groups
1
Description
alfa-lipoic acid 900mg/day for 10 days
Category
Treatment - Drugs
2
Description
placebo for 10 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital- emergency ICU
Full name of responsible person
Street address
City
Shiraz
2
Recruitment center
Name of recruitment center
Namazi hospital- general ICU
Full name of responsible person
Street address
Namazi hospital
City
Shiraz
3
Recruitment center
Name of recruitment center
Namazi hospital- central ICU
Full name of responsible person
Street address
Namazi hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
shiraz university of medical sciences-vice chancellor for research affairs
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
shiraz university of medical sciences- nutrition department
Full name of responsible person
najmeh hejazi
Position
PhD candidate of Nutrition
Other areas of specialty/work
Street address
shiraz university of medical sciences-school of health and nutrition- nutrition department
City
shiraz
Postal code
Phone
+98 71 1725 1001
Fax
Email
n20hejazi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
shiraz university of medical sciences, department of nutrition
Full name of responsible person
dr.Zohreh Mazloom
Position
Associate Professor of nutrition
Other areas of specialty/work
Street address
shiraz university of medical sciences, school of health and nutrition, department of nutrition
City
shiraz
Postal code
Phone
+98 71 1725 1009
Fax
Email
zohreh_mazloom@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
shiraz university of medical sciences- nutrition department
Full name of responsible person
najmeh hejazi
Position
PhD candidate of Nutrition
Other areas of specialty/work
Street address
shiraz university of medical sciences-school of health and nutrition- nutrition department
City
Postal code
Phone
00
Fax
Email
n20hejazi@yahoo.com
nhejazi@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)