This randomized double blind placebo controlled clinical trial which will be conducted on 92 alert and non-delirious inpatients in the ICU ward imam reza hospital, in Kermanshah, to prevent delirium incidence.After inclusion and exclusion criteria implementation, patients will be selected, patients will be divided in 2 groups randomly. In the first group (case) 3 mg melatonin and in second group (control) placebo administration will be performed at 9 p.m. for a week or until discharge from ICU. Patients will be matched for underlying disease. The assessment of delirium will be done on a daily basis by a single educated nurse using Confusion Assessment Method for the ICU (CAM-ICU). All data will be recorded and then analyzed. After final analysis, the results will be announced.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061234482N1
Registration date:2017-09-01, 1396/06/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-01, 1396/06/10
Registrant information
Name
Maryam Shirzadi
Name of organization / entity
Kermanshah University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 83 3826 5255
Email address
m_shirzadi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Kermanshah University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study of the effect of melatonin on prevention of delirium in Intensive Care Unite (ICU) inpatients
Public title
effect of melatonin on prevention of delirium in admitted patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Ag 18 or above; admitted in ICU; Consciousness
Exclusion criteria: Dementia; Critically ill patients; having contraindication of melatonin use; being a current user of melatonin
Age
From 18 years old to 100 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomly by tossing coin
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Number 2 Building, Shahid Beheshti Boulevard
City
Kermanshah
Postal code
4733315444
Approval date
2017-02-05, 1395/11/17
Ethics committee reference number
KUMS.REC.1395.761
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
F05
ICD-10 code description
Delirium, not induced by alcohol and other psychoactive substances
Primary outcomes
1
Description
Delirium incidence
Timepoint
Daily
Method of measurement
CAM-ICU
Secondary outcomes
1
Description
number of admition days
Timepoint
after discharge from hospital
Method of measurement
patient records
Intervention groups
1
Description
Intervention group: 3 mg melatonin at 9 p.m for a week or till discharge from ICU
Category
Prevention
2
Description
control group: Placebo tab at 9 p.m for a week or till discharge from ICU
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah Imam Reza Hospital
Full name of responsible person
Dr Maryam Shirzadi
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Dr Behrouz Hamzeh
Street address
Number 2 Building, Shahid Beheshti Boulevard
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah 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
Kermanshah University Of Medical Science
Full name of responsible person
Dr Maryam Shirzadi
Position
Assisstant Professor Of Psychiatry
Other areas of specialty/work
Street address
Kermanshah Imam Reza Hospital
City
Kermanshah
Postal code
Phone
+98 83 3427 6310
Fax
Email
m_shirzadi@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University Of Medical Science
Full name of responsible person
Dr Maryam Shirzadi
Position
Psychiatrist
Other areas of specialty/work
Street address
Imam Reza Hospital
City
kermanshah
Postal code
Phone
+98 83 3427 6310
Fax
Email
m_shirzadi@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University Of Medica Science
Full name of responsible person
Dr Maryam Shirzadi
Position
Psychiatrist
Other areas of specialty/work
Street address
Imam Reza Hospital
City
Kermanshah
Postal code
Phone
+98 83 3427 6310
Fax
Email
m_shirzadi@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)