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Protocol summary
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Study aim
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The aim of current study is to investigate the role of hypothyroidism in difficult weaning from mechanical ventilation.
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Design
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Clinical trial study, with parallel groups, double blinded, randomized
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Intervention group: Levothyroxine prescription
Control group: Non-prescribed levothyroxine
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Main outcome variables
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Weaning time
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120605009948N7
Registration date:
2019-09-10, 1398/06/19
Registration timing:
retrospective
Last update:
2020-11-12, 1399/08/22
Update count:
1
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Registration date
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2019-09-10, 1398/06/19
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2017-02-19, 1395/12/01
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Expected recruitment end date
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2018-02-20, 1396/12/01
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Actual recruitment start date
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2018-03-06, 1396/12/15
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Actual recruitment end date
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2019-01-27, 1397/11/07
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Trial completion date
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2019-03-01, 1397/12/10
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Scientific title
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Difficult weaning of mechanical ventilation due to hypothyroidism
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Public title
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Hypothyroidism in mechanical ventilation
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
80
Actual sample size reached:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-02-16, 1395/11/28
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Ethics committee reference number
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IR.TBZMED.REC.1395.1226
Health conditions studied
1
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Description of health condition studied
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Hypothyroidism
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ICD-10 code
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E03
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ICD-10 code description
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Other hypothyroidism
Primary outcomes
1
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Description
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Weaning time
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Timepoint
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Daily
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Method of measurement
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Using the questionnaire
Intervention groups
1
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Description
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Intervention group: Levothyroxine prescription at a daily dose of 0.1 mg through the nasogastric tube until extubation (Sodium levothyroxine tablet, Iran hormone product)
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Category
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Treatment - Drugs
2
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Description
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Control group: Non-prescribed levothyroxine
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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We have not yet set a conclusion
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When the data will become available and for how long
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We have not yet set a conclusion
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To whom data/document is available
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We have not yet set a conclusion
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Under which criteria data/document could be used
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We have not yet set a conclusion
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From where data/document is obtainable
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We have not yet set a conclusion
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What processes are involved for a request to access data/document
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We have not yet set a conclusion
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Comments
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