Determination of the effect of mega does l-carnitine supplementation on the level of inflammatory factors in patients with acute pulmonary respiratory distress syndrome in ICU
Design
This study was an interventional study and the number of 50 patients with acute pulmonary respiratory distress in the age range of 18-65 years old admitted to the intensive care unit of Imam Reza Hospitals of Mashhad introduced by a specialist after obtaining informed consent from patients or their companions will be included in the study.25 patients with ARDS are randomly assigned to case and control groups.
Settings and conduct
imam reza
Participants/Inclusion and exclusion criteria
inclusion criteria:• Age of 18 -65 years, Conscious informed consent
exteria criteria:Dissatisfaction with the patient or family of the patient to continue the intervention, Patients with liver and kidney failure, Patients who have cancer and are taking chemotherapy and cisplatin, Patients taking phenobarbital and phenytoin anti-inflammatory drugs,Patients taking pivolic acid, valproic acid, and fosfamide drugs,Patients undergoing dialysis.
Intervention groups
25 patients with ARDS are randomly assigned to case and control groups. The entry of each patient into the case or control group will be randomized with the help of numbers in sealed envelopes. After obtaining consent, 10 cc blood samples are taken from blood patients to evaluate the serum level of L-carnitine and blood samples are taken to evaluate the inflammatory and oxidative factors in a negative 80 ° C refrigerator. At the beginning of the study, APACHEII, The organ failure function questionnaire (SOFA) and patient nutrition status questionnaire (Nutric score) are obtained from patients.Then the patient's body mass index (BMI), demographic characteristics, laboratory data and drug and dietary information are recorded for each patient. كار
Main outcome variables
in
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151108024938N2
Registration date:2018-05-30, 1397/03/09
Registration timing:prospective
Last update:2018-05-30, 1397/03/09
Update count:1
Registration date
2018-05-30, 1397/03/09
Registrant information
Name
Alireza Sedaghat
Name of organization / entity
Mashhad university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 3701
Email address
sedaghatar@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-09, 1397/03/19
Expected recruitment end date
2018-08-25, 1397/06/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of high-dose anti-inflammatory effects of l-carnitine in patients with acute respiratory distress syndrome in the intensive care unit
Public title
Evaluation of high-dose anti-inflammatory effects of l-carnitine
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 -65 years
Conscious informed consent
Patients with acute respiratory distress syndrome
Patients with recently diagnosed acute respiratory distress syndrome
Exclusion criteria:
Dissatisfaction with the patient or family of the patient to continue the intervention
Patients with liver and kidney failure
Patients who have cancer and are taking chemotherapy and cisplatin
Patients taking phenobarbital and phenytoin anti-inflammatory drugs
Patients taking pivolic acid, valproic acid, and fosfamide drugs
Patients undergoing dialysis
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data and Safety Monitoring Board
Sample size
Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
2
at first and at the end of study has been take the blood (10 cc)
Randomization (investigator's opinion)
Randomized
Randomization description
25 patients with ARDS are simple randomly assigned to case and control groups. The entry of each patient into the case or control group will be randomized with the help of numbers in sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, commercially available l-carnitine supplements with a dose of 3000 Mg and pasteurized drinking water as a randomly packaged placebo (blinded) are given to the patients by nurses and supervised by the team during the specified period of time for 21 days in the treatment of gastritis.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of medical university of mashhad
Street address
imam reza hospital,daneshgah street,Mashhad,Iran
City
mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2018-04-09, 1397/01/20
Ethics committee reference number
IR.MUMS.fm.REC.1396.671
Health conditions studied
1
Description of health condition studied
Acute respiratory distress syndrome
ICD-10 code
J80
ICD-10 code description
Acute respiratory distress syndrome
Primary outcomes
1
Description
IL-6
Timepoint
The first of study,the end of study 21th day
Method of measurement
ELISA
Secondary outcomes
1
Description
Anthropometric indices
Timepoint
before and after study
Method of measurement
ELISA
2
Description
MAC
Timepoint
before and after study
Method of measurement
. The height of each patient is measured in the lying state or through the length of the ulna and the circumference of the middle of the non-dominant hand arm with a non-transient strip meter with an accuracy of 5.5 cm.
3
Description
APACHEⅡ questionair
Timepoint
before and after study
Method of measurement
in this study, APACHEII questionnaire will be complimented.
4
Description
SOFA
Timepoint
before and after study
Method of measurement
in this study, SOFA questionnaire will be complimented.
5
Description
NUTRIC score questionnaire
Timepoint
before and after study
Method of measurement
in this study, NUTRIC score questionnaire will be complimented.
intervention groups:25 patients with ARDS who receive commercially available l-carnitine supplements with a dose of 3000 Mg are given to the patients by nurses and supervised by the team during the specified period of time for 21 days in the treatment of Gavage.
Category
Treatment - Drugs
2
Description
Control group: 25 patients with ARDS who receive pasteurized drinking water as a randomly packaged placebo are given to the patients by nurses and supervised by the team during the specified period of time for 21 days in the treatment of Gavage,the placebo is made that medical University of mashhad.Intervention groups and control groups are randomly assigned to case and control groups.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emamreza hospitals
Full name of responsible person
Alireza sedaghat
Street address
Emam reza hospital,daneshgah AVE
City
Mashhhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3802 3701
Fax
+98 51 3871 3638
Email
SedaghatAr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen tafaghodii
Street address
Khorasan Razavi - Mashhad University Street- opposite Khayyayan University 18- Mashhad University of Medical Sciences-
City
Mashhad
Province
Razavi Khorasan
Postal code
91778 99191
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abdolreza Norozi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Nutrition
Street address
Khorasan Razavi - Mashhad University Street- Opposite of Daneshgah 18- Mashhad University of Medical Sciences-
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3882 7034
Email
Norouzya@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abdolreza Norozi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Nutrition
Street address
Khorasan Razavi - Mashhad University Street- opposite Khayyayan University 18- Mashhad University of Medical Sciences-
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3882 7034
Email
Norouzya@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Sedaghat
Position
Associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Knowledge and Health City – In the end of Shahid Fakouri Blvd (In front of Fakouri 94) – Mashhad - Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3802 3701
Fax
+98 51 3841 3006
Email
sedaghatar@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Evaluation of high-dose anti-inflammatory effects of lcarnitine in patients with acute respiratory distress syndrome in the intensive care unit
When the data will become available and for how long
This may be provided as an absolute date 1397,starting 6 months after publication
To whom data/document is available
Alireza sedaghat ,Abdolreza norozi
Under which criteria data/document could be used
Use of the data is only possible after publication of the article.
From where data/document is obtainable
Mashhad medical university,
yahyapourof951@mums.ac.ir ,farvehyahyapour,
What processes are involved for a request to access data/document