Determination of the efficacy and safety of clonidine on delirium symptoms compared with placebo in patients with delirium-induced delirium-19
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized on 40 patients with Covid-19 delirium, which according to the random number table are divided into two experimental and control groups with 20 subjects, will receive drug and placebo respectively.
Settings and conduct
This study is performed on patients with delirium caused by Covid-19 admitted to the ICU of Sabzevar Vasei Hospital. The study will be a double-blind study comparing the effect of clonidine and placebo tablets on the symptoms of delirium in these patients. Patients will be divided into experimental and control groups using a table of random numbers.
Participants/Inclusion and exclusion criteria
Patients with Covid-19 delirium over 18 years of age
Intervention groups
The experimental group receives clonidine and the control group receives exactly the same clonidine tablets but no drug content.
Main outcome variables
The effect of clonidine on delirium symptoms and side effects of clonidine in lowering blood pressure and heart rate in these patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210425051075N2
Registration date:2022-08-24, 1401/06/02
Registration timing:retrospective
Last update:2022-08-24, 1401/06/02
Update count:0
Registration date
2022-08-24, 1401/06/02
Registrant information
Name
Houman Kamranian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4465 1037
Email address
kamranianh@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-07, 1400/07/15
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of clonidine effectiveness in decreasing signs of delirium in covid-19 patients admitted toICU
Public title
Evaluation of clonidine effectiveness in decreasing signs of delirium in covid-19 patients admitted toICU
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients admitted to the ICU due to Covid-19
Delirium based on CAM-ICU
Age older than 18 years
Exclusion criteria:
Systolic blood pressure below 90 mmHg at the beginning of the intervention or at any time during the intervention
Diastolic blood pressure less than 60 mmHg at the beginning of the intervention or at any time during the intervention
Heart rate less than 60 beats per minute at the beginning of the intervention or at any time during the intervention
Severely aggressive patients who need to be injected to control aggression.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization
Randomization unit: individual
Randomization tool: Random number table
Concealment method: A nurse uses a table of random numbers to place the patient in the experimental or control group. And provides the box of the drug or placebo to the nurse assistant researcher to prescribe the drug to the patient and fill out the questionnaires.
Blinding (investigator's opinion)
Double blinded
Blinding description
After receiving the doctor's order, a nurse uses a table of random numbers to place the patient in the experimental or control group. The medicine box or placebo is given to the assistant nurse researcher and prescribed to the patient. Evaluation by questionnaires is also done by the same researcher who does not know the content of the boxes. The doctor also does not know which patients are taking the main medicine and which are taking the placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Sabzevar University of Medical Sciencesکمیته اخلاق درپژوهش دانشگاه علوم
Street address
Tohid Shahr Boulevard, Vasei Hospital - Psychiatric Department
City
sabzevar
Province
Razavi Khorasan
Postal code
9617747431
Approval date
2021-08-22, 1400/05/31
Ethics committee reference number
IR.MEDSAB.REC.1400.072
Health conditions studied
1
Description of health condition studied
Covid-19 , Delirium
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition
Primary outcomes
1
Description
Delirium-based CAM-ICU
Timepoint
Throughout the patient's stay in the ICU, the assessment is performed twice a day, in the morning and in the evening
Method of measurement
CAM-ICU = Confusion Assessment Method-ICU and RASS=Richmond Agitation Sedation Questionnaires
2
Description
clonidine side effects
Timepoint
twice daily
Method of measurement
Based on a questionnaire adapted from pharmaceutical references
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Clonidine recipients in the form of 0.2 mg tablets, starting as 0.1 mg (half a tablet) every 12 hours and increasing to 1 mg per day in divided doses, depending on the patient's condition.
Category
Treatment - Drugs
2
Description
Control group: Pills without drug content that are similar in shape to clonidine tablets and in the same way, half a tablet is started every 12 hours and up to 5 tablets per day are given to the control group in divided doses.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Vasei Hospital
Full name of responsible person
Hooman Kamranian
Street address
Tohid Shahr Boulevard
City
sabzevar
Province
Razavi Khorasan
Postal code
9617747431
Phone
+98 51 4465 1300
Fax
+98 51 4465 3861
Email
waseehospital@medsab.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Hosein Saghi
Street address
Sabzevar University of Medical Sciences Campus - Tohid Town Boulevard
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8319
Fax
+98 51 4401 8484
Email
vc.Research@medsab.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
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
Sabzevar University of Medical Sciences
Full name of responsible person
Houman Kamranian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Vasei Hospital - Tohid Town Boulevard
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617747431
Phone
+98 51 4465 1300
Email
kamranianh@medsab.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Reza ShegarfNakhaie
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Vasei Hospital - Tohid Town Boulevard
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617747431
Phone
+98 51 4465 1300
Email
rezashegarf@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Reza Shegarf Nakhaie
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Vasei Hospital - Tohid Boulevard
City
sabzevar
Province
Razavi Khorasan
Postal code
9617747431
Phone
+98 51 4465 1300
Email
rezashegarf@yahoo.com
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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data related to the participants can be shared after deleting the name
When the data will become available and for how long
Access starts 6 months after the results are published
To whom data/document is available
Only researchers working in academic and scientific institutions will be able to receive data and other documents
Under which criteria data/document could be used
All people working in academic and scientific centers will be able to receive authorized documents by sending an email
From where data/document is obtainable
Internet address in order of priority:
kamranianh@medsab.ac.ir
rezashegarf@yahoo.com
What processes are involved for a request to access data/document
After sending the application by e-mail and specifying the academic position, the documents will be sent by e-mail within one month.