Purpose of the study is comparing cyproheptadine and placebo efficacy in prevention of delirium incidence in critically ill patients. In a double blind randomized clinical trial 40 non-cardiac surgical patients who are admitted to general ICU of Imam Khomeini Hospital will be recruited. Patients with cyproheptadine contraindication will be excluded. Recruited patients simply randomized in the cyproheptadine or placebo group. Patients in cyproheptadine group will be received cyproheptadine tablet 4 mg orally three times daily for 7 days from the day of ICU admission. Patients in control group will receive placebo tablet orally three times daily for 7 days from the day of ICU admission. Cyproheptadine and placebo tablets are same in packaging and the responsible researchers and patients will be blinded. Incidence of delirium will be assessed as daily interval based on the Confusion Assessment Method- Intensive Care Unit (CAM-ICU) questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201312203449N13
Registration date:2014-01-10, 1392/10/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-10, 1392/10/20
Registrant information
Name
Hossein Khalili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4715
Email address
khalilih@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Grant of Tehran University of Medical Sciences
Expected recruitment start date
2013-10-01, 1392/07/09
Expected recruitment end date
2015-10-01, 1394/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing cyproheptadine and placebo efficacy in prevention of delirium incidence in patients hospitalized in intensive care unit
Public title
Cyproheptadine for prevention of delirium in critically ill patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Non-cardiac surgical patients who are admitted to ICU and are hospitalized in Intensive Care Unit (ICU) for at-least 7 days.
Exclusion Criteria: Patients with history of neurological diseases, psychiatric disorders, cyproheptadine hypersensitivity, active GI bleeding, glaucoma, urinary retention and arrhythmia will be excluded from the study.
Age
From 16 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Ghods Ave.
City
Tehran
Postal code
Approval date
2013-09-01, 1392/06/10
Ethics committee reference number
92-02-33-23168
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
F54
ICD-10 code description
Sudden changes in patients’ behavioral and psychological conditions
Primary outcomes
1
Description
Incidence of Delirium
Timepoint
At ICU admission and then daily for 7 days
Method of measurement
CAM-ICU Questionnaire
Secondary outcomes
1
Description
Severity of Delirium
Timepoint
At ICU admission and then daily for 7 days
Method of measurement
CAM-ICU Questionnaire
Intervention groups
1
Description
Cyproheptadine Tab (Amin Pharmaceutical Company, Isfahan, IRAN), 4mg TDS orally from admission time, as daily interval for 7 days. Incidence and severity of patients’ delirium will be assesses as daily interval based on the CAM-ICU questionnaire.
Category
Prevention
2
Description
Placebo Tab (Amin Pharmaceutical Company, Isfahan, IRAN), 4mg TDS orally from admission time, as daily interval for 7 days. Incidence and severity of patients’ delirium will be assesses as daily interval based on the CAM-ICU questionnaire.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Hossein Khalili
Street address
Keshavarz Blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Masoud Yunesian
Street address
Ghods Ave.
City
Tehran
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, Tehran 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Pharm. D
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6695 4715
Fax
Email
khalilih@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Pharm. D
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6695 4715
Fax
Email
khalilih@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)