The aim of current study is to investigate the role of hypothyroidism in difficult weaning from mechanical ventilation.
Design
Clinical trial study, with parallel groups, double blinded, randomized
Settings and conduct
80 patients under mechanical ventilation for more than a week were enrolled the study and were divided in two equal group, randomly. The first group received routine treatment and the second group received the first 0.1 milligram levothyroxine daily in addition to the routine treatments. The outcome of treatment and the possibility of weaning were evaluated between the two groups. The findings were compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients without previously known thyroid disease
Mechanical ventilation more than one week
Exclusion criteria:
Brain and lung diseases
History of interfering drugs with thyroid consumption such as Lithium
Patient dissatisfaction
History of heart diseases
Arrhythmia without cause
Patients with history of Hypothyroidism
Intervention groups
Intervention group: Levothyroxine prescription
Control group: Non-prescribed levothyroxine
Main outcome variables
Weaning time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120605009948N7
Registration date:2019-09-10, 1398/06/19
Registration timing:retrospective
Last update:2019-09-10, 1398/06/19
Update count:1
Registration date
2019-09-10, 1398/06/19
Registrant information
Name
Majid Montazer
Name of organization / entity
Tabriz University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 8435
Email address
montazerma@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
2018-03-06, 1396/12/15
Actual recruitment end date
2019-01-27, 1397/11/07
Trial completion date
2019-03-01, 1397/12/10
Scientific title
Difficult weaning of mechanical ventilation due to hypothyroidism
Public title
Hypothyroidism in mechanical ventilation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients without previously known thyroid disease
Mechanical ventilation more than one week
Exclusion criteria:
Brain and lung diseases
History of interfering drugs with thyroid consumption such as Lithium
Patient dissatisfaction
History of heart diseases
Arrhythmia without cause
Patients with history of Hypothyroidism
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals with inclusion criteria were recruited by a non-random sample method. Then, random allocation was done to form study groups. In this study, a block randomization method (including quadruple blocks) was used. One of non-blinded colleagues of this study, named the catheter implantation method with the letters A and B. Then, the researcher distributed A and B envelopes among patients in a randomized block method for participating in the study. Then, selecting the blocks was continued until achieving the sample size. The method of making random sequence was done using a simple randomization. To make a random sequence for the possible blocks, (6 blocks) we gave numbers to them from 1 to 6. Regarding the sample size, the required quadruple number of blocks was used. The number of blocks was chosen from the random numbers table and based on these numbers the sequence of blocks in each group was identified.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, blinding was carried out as follows:
The data collector : because of the lack of information about the prescription or not of levothyroxine was blinded.
Patients were blinded: because they were not supposed to be aware of the levothyroxine prescription
Blinding/Blindfolding Method: Based on the sequence of random numbers, the groups A or B were placed inside sealed envelopes. A researcher who was not aware of the contents and sequence of the envelopes respectively opened the envelopes, and depending on whether they were A or B, levothyroxine was prescribed for them or not. Only one member of team knew A or B was according to which catheter implantation method.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences., Golgasht St., Azadi St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2017-02-16, 1395/11/28
Ethics committee reference number
IR.TBZMED.REC.1395.1226
Health conditions studied
1
Description of health condition studied
Hypothyroidism
ICD-10 code
E03
ICD-10 code description
Other hypothyroidism
Primary outcomes
1
Description
Weaning time
Timepoint
Daily
Method of measurement
Using the questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Levothyroxine prescription at a daily dose of 0.1 mg through the nasogastric tube until extubation (Sodium levothyroxine tablet, Iran hormone product)
Category
Treatment - Drugs
2
Description
Control group: Non-prescribed levothyroxine
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Majid Montazer Bavil
Street address
Imam Reza Hospital, Golgasht St., Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166615556
Phone
+98 41 3334 7056
Email
info@imamreza.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Vice-Chancellor of research, Tabriz University of Medical Sciences
Street address
Golgasht Ave.,
City
Tabriz
Province
East Azarbaijan
Postal code
5166615556
Phone
+98 41 3333 5333
Email
skshakouri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mahid Montazer Bavil
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Daneshghah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166615556
Phone
+98 41 3335 7852
Email
montazerma@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Majid Montazer Bavil
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Daneshghah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166615556
Phone
+98 41 3335 7852
Email
montazerma@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Majid Montazer Bavil
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Daneshghah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166615556
Phone
+98 41 3335 7852
Email
montazerma@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
We have not yet set a conclusion
When the data will become available and for how long
We have not yet set a conclusion
To whom data/document is available
We have not yet set a conclusion
Under which criteria data/document could be used
We have not yet set a conclusion
From where data/document is obtainable
We have not yet set a conclusion
What processes are involved for a request to access data/document