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The impact of adding clonidine in total sedative agents use in mechanically ventilated patients in the intensive care unit: A prospective, randomized, double blind study

Protocol summary

Summary
The purpose of this study is evaluation of sedative effects of clonidine and it’s role in decreasing total sedative agents use including opiods, midazolam, other benzodiazepines, and propofol in critically ill mechanically ventilated patients In this randomized, double blinded, 2-armed parallel group clinical trial, 40 patients will be recruited from intensive care unit, Imam Hussein hospital, SBMU, Tehran, Iran. After randomization the subjects in group A will receive clonidine 0.1mg TDS at day 1 and then 0.2mg TDS for 7 days. Subjects in group B will receive placebo. Primary outcome measure is change in total sedative agents use including opiods, midazolam, other benzodiazepines, and propofol in two groups Secondary outcome measures include: 1-duration of mechanical ventilation 2- length of stay in ICU 3- serum level of clonidine in critically ill patients 3 and 7 after oral days administration of clonidine

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012102910178N3
Registration date: 2012-11-14, 1391/08/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-11-14, 1391/08/24
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
2012-10-22, 1391/08/01
Expected recruitment end date
2013-05-21, 1392/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of adding clonidine in total sedative agents use in mechanically ventilated patients in the intensive care unit: A prospective, randomized, double blind study
Public title
Effect of clonidine in total sedative agents use in the intensive care unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients on mechanical ventilation Exclusion criteria:mechanical ventilation less than 3 days; sepsis; volume depletion; second or third degree atrioventricular node block; GFR < 15 ml/min; hepatic failure (Child Pough score: severe); GCS < 8; use of clonidine during past month
Age
From 18 years old to 149 years old
Gender
Both
Phase
N/A
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
Shahid Beheshti University of Medical Sciences
Street address
Velenjak Street, Shahid Chamran High Way
City
Tehran
Postal code
Approval date
2012-07-31, 1391/05/10
Ethics committee reference number
1391-1-94-10124

Health conditions studied

1

Description of health condition studied
Mechanically ventilated patients in the intensive care unit
ICD-10 code
J00-J99
ICD-10 code description
Diseases of the respiratory system

Primary outcomes

1

Description
Total sedative agents use including opiods, midazolam, other benzodiazepines and propofol
Timepoint
Daily
Method of measurement
Total daily dose

Secondary outcomes

1

Description
clonidine blood level
Timepoint
day 4 and 7
Method of measurement
ELisa kit

2

Description
Duration of mechanical ventilation
Timepoint
Daily
Method of measurement
Daily

3

Description
Duration of ICU LOS
Timepoint
Daily
Method of measurement
Daily

Intervention groups

1

Description
clonidine 0.1mg TDS orally day 1 then 0.2mg TDS orally for total of 7 days
Category
Treatment - Drugs

2

Description
Placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
ICU, Imam Hussein Hospital
Full name of responsible person
Mohammad Sistanizad
Street address
Shahid Madani Street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
shahid beheshti university of medical sciences
Full name of responsible person
Tahereh shams
Street address
Velenjak street, shahid chamran High Way
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 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
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 21 8820 0087
Fax
Email
sistanizadm@sbmu.ac,ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid Mokkhtari
Position
Assistant Professor / FCCP
Other areas of specialty/work
Street address
ICU, Imam Hussein Hospital, Shahid Madani Street
City
Tehran
Postal code
Phone
+98 21 7755 8081
Fax
Email
majidmokh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
Full name of responsible person
Maryam Farasatinasab
Position
Clinical Pharmacist
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niaesh Highway
City
Tehran
Postal code
Phone
00
Fax
Email
mary_farasati@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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