Clinical trial of the effect of melatonin administration on duration of mechanical ventilation in patients requiring hospitalization in the intensive care unit
The effect of melatonin administration on duration of mechanical ventilation in patients requiring hospitalization in the intensive care unit of Golestan hospital, Ahvaz
Design
This study will be a randomized double-blind controlled clinical trial in 60 patients who will be randomly divided into two groups: medication and control group, in order to examine the effect of prescribing melatonin on the duration of mechanical ventilation in comparison with placebo among ICU patients.The randomisation method will be the use of a random number table and the phase of clinical trial is phase 4.
Settings and conduct
This study will be carried out among 60 patients hospitalized in ICU of Golestan hospital in Ahvaz. After obtaining written consent form, the patients will be randomly divided into case group and placebo group by means of table of random numbers.
The patients in case group and palcebo group will receive 3mg melatonin or the placebo through nasogastric tube every night at 9 P.M. The prescription will be continued until weaning the mechanical ventilation.
Participants/Inclusion and exclusion criteria
The Inclusion criteria:
Patients older than 18-year-old who entered the ICU with the reduced GCS and need for mechanical ventilation in first 48-hour hospitalization
The exclusion criteria:
liver failure; Kidney failure; Pregnancy; Patients with brain tumor; Patients with GCS<4; The hypersensitivity history of melatonin
Intervention groups
Intervention group: the group that takes melatonin.
Control group : the group that takes placebo.
Main outcome variables
The duration of mechanical ventilation; Ventilator associated pneumonia occurrence; The duration of ICU stay; Mortality rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170729035360N1
Registration date:2018-01-11, 1396/10/21
Registration timing:registered_while_recruiting
Last update:2018-01-11, 1396/10/21
Update count:0
Registration date
2018-01-11, 1396/10/21
Registrant information
Name
Mandana Izadpanah
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8378
Email address
izadpanah-m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology Development of the َAhvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of melatonin administration on duration of mechanical ventilation in patients requiring hospitalization in the intensive care unit
Public title
Evaluation of effect of melatonin on the duration of mechanical ventilation in patients requiring hospitalization in the intensive care unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
admition in intensive care unit
age older than 18 year old
need for mechanical ventilation
Exclusion criteria:
Hepatic failure
kidney Failure
Pregnancy
Brain Tumor
The hypersensitivity history of melatonin
Patients with GCS<4
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, Table of random number will be used for random assignment to intervention and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be conducted as a double-blind study. The patient, the prescribing physician, as well as the nurse, will not be aware of the contents of the coded packaged medication or placebo.
Placebo
Used
Assignment
Parallel
Other design features
In randomization we use a random number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Jundishapur University of Medical Sciences, Golestan boulevard, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Approval date
2017-07-22, 1396/04/31
Ethics committee reference number
IR.AJUMS.REC.1396.395
Health conditions studied
1
Description of health condition studied
Dependence on respirator
ICD-10 code
Z99.1
ICD-10 code description
Dependence on respirator
Primary outcomes
1
Description
The duration of mechanical ventilation dependence
Timepoint
daily
Method of measurement
visual
Secondary outcomes
1
Description
mortality
Timepoint
daily
Method of measurement
visual
2
Description
The duration of hospitalization in the intensive care unit
Timepoint
daily
Method of measurement
visual
Intervention groups
1
Description
Prescription of melatonin, 3 mg daily, in intervention group
Category
Treatment - Drugs
2
Description
prescription of placebo, daily, in control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Dr Mandana Izadpanah
Street address
Golestan hospital, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
33118-61357
Phone
+98 61 3373 8378
Email
Izadpanah-m@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology Development of the َAhvaz Jundishapur University of Medical Scienc
Full name of responsible person
Dr Behzad Sharif Makhmalzadeh
Street address
Jundishapur University of medical sciences, Golestan boulevard, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3373 8378
Email
izadpanah-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology Development of the َAhvaz Jundishapur University of Medical Scienc
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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mandana Izadpanah
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ahvaz, Golestan, Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
33184-61357
Phone
+98 61 3373 8378
Fax
+98 61 3373 8381
Email
izadpanah-m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mandana Izadpanah
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ahvaz, Golestan, Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
33184-61357
Phone
+98 61 3373 8378
Fax
+98 61 3373 8381
Email
izadpanah-m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mandana Izadpanah
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ahvaz, Golestan, Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
33184-61357
Phone
+98 61 3373 8378
Fax
+98 61 3373 8381
Email
izadpanah-m@ajums.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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The results of the study will be published in an original article after the study is completed.
When the data will become available and for how long
Access to the article will begin after publishing the article.
To whom data/document is available
Only for researchers working in academic institutions and scientific data will be available.
Under which criteria data/document could be used
The data for this study are available for use in review articles, systematic analyzes.
From where data/document is obtainable
Dr. Mandana Izadpanah
Ahvaz Jundishapur University of Medical Sciences
00989163012599
Izadpanah-m@ajums.ac.irِ
What processes are involved for a request to access data/document
After sending the email to the responsible author, the request will be answered as soon as possible.