This trial is to evaluate aripiprazole effect on prevention of delirium. This is a randomized, double blind, 2-armed parallel group clinical trial. Subjects are patients in in neurosurgical Intensive care unit in Firoozgar hospital, Tehran, Iran. Patients with active delirium, history of anti-psychotic therapy and bradycardia will be excluded.40 patients will be enrolled. After randomization of the subject, 20 subjects in group A will receive aripiprazole 15mg daily by oral rout and 20 subjects in group B will receive placebo. The Confusion Assessment Method for the ICU will be used as validation tool for measurement of delirium daily. Finally the trend of The Confusion Assessment Method for the ICU will be compared between two groups. The primary objectives of this trial is to compare the incidence of delirium between control and intervention group using The Confusion Assessment Method for the ICU.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011810178N12
Registration date:2017-03-06, 1395/12/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-06, 1395/12/16
Registrant information
Name
Mohammad Sistanizad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0087
Email address
sistanizadm@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of aripiprazole as add on therapy for delirium prophylaxis in patients admitted to the intensive care unit
Public title
Effect of aripiprazole on prevention of delerium
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 18-80 yo patients admitted to intensive care unit
Exclusion criteria: pregnancy; breastfeeding; preexisting active delirium; bradycardia (heart rate <60); alcohol intoxication; liver failure (Child Pough Score: sever); kidney failure(GFR<15); history of anti-psychotic drug(s); ICU stay less than 3 days
Age
From 18 years old to 80 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 Shahid Beheshti University of Medical Sciences
Street address
Velenjak Street, Shahid Chamran High Way
City
Tehran
Postal code
Approval date
2016-07-20, 1395/04/30
Ethics committee reference number
IR.SBMU.PHNM.1395.408
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
Entrance to study, Daily for 7 days
Method of measurement
Evaluation of CAM-ICU score
Secondary outcomes
1
Description
Drug effect on Lipid profile
Timepoint
Day 0 and 7
Method of measurement
Blood sample
2
Description
Drug effect on blood sugar
Timepoint
Daily
Method of measurement
Blood sample
3
Description
Drug effect on liver function tests
Timepoint
Day 0 and 7
Method of measurement
Blood sample
4
Description
Drug effect on ICU stay
Timepoint
Daily
Method of measurement
Counting the Admission days
Intervention groups
1
Description
Intervention: Tablet aripiprazole 15 mg daily orally for seven days
Category
Treatment - Drugs
2
Description
Control: Tablet placebo once daily for 7 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar General Hospital
Full name of responsible person
Maryam Farasatinasab
Street address
Behafarin St., Karimkhan Zand St., Vali-e-asr Sq.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Tahereh Shams
Street address
Velenjak Street, Shahid Chamran Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Science
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
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Sistanizad
Position
Assistant Professor, Clinical Pharmacy Specialist
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
City
Tehran
Postal code
Phone
+98 218800087
Fax
Email
sistanizadm@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
ّDepartmant of critical care,Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid mokhtari
Position
Assistant Professor, Pulmonologist
Other areas of specialty/work
Street address
Shahid Madani street, Imam Hussein hospital
City
Tehran
Postal code
Phone
+98 21 73430
Fax
Email
majidmokh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti university of medical science
Full name of responsible person
Mina Jafarpoor
Position
Pharmacy student
Other areas of specialty/work
Street address
Vali-e-asr St,Niayesh
City
Tehran
Postal code
Phone
+98 21 8820 0118
Fax
Email
mina.jafarpour2020@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)