The effects of testosterone injection in maintaining the stability of blood pressure and hemodynamic parameters of brain dead patients who are candidates for organ donation
Improving the hemodynamic conditions and blood pressure of patients with minimal inotrope or vasopressor drugs with testosterone injection in brain dead patients who are candidates for organ donation
Design
A clinical trial with the control group, with parallel groups, double-blind, randomized, phase 2-3 on 80 patients. Computer-generated random table method was used for randomization
Settings and conduct
This double-blind clinical trial will be conducted on 80 male-female brain dead patients who are candidates for organ donation with flank incision at Sina Hospital in Tehran. The patients are divided into two groups by Computer-generated random table . This study is double blind clinical trial. Outcome analyser , the outcome evaluator and the participant are blinded (double blind).Control group patients receive 100 mg of testosterone intramuscularly. Blood pressure the dose of noradrenaline that is infused is checked duringhospitalization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: brain dead patients aged 18-60 who are candidates for organ donation.
Exclusion criteria: patients who have high blood pressure and do not need inotrope. Hemodynamically unstable patients whose organ donation surgery will be performed in less than 6 hours.
Intervention groups
Intervention group: the amount of 100 mg of testosterone is injected into the deltoid muscle at the beginning of the study. Control group: the same amount of placebo drug is injected into the deltoid muscle.
Main outcome variables
The amount of vasopressor drugs, systolic blood pressure, diastolic and mean arterial blood pressure, cardiac output, peripheral vascular resistance, cardiac index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130304012695N17
Registration date:2023-05-13, 1402/02/23
Registration timing:prospective
Last update:2023-05-13, 1402/02/23
Update count:0
Registration date
2023-05-13, 1402/02/23
Registrant information
Name
mohammadreza khajavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 1220
Email address
khajavim@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of testosterone injection in maintaining the stability of blood pressure and hemodynamic parameters of brain dead patients who are candidates for organ donation
Public title
The use of testosterone in brain dead patients who are candidates for organ donation in order to maintain and stabilize blood pressure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Brain dead patients aged 18-60 years are candidates for organ donation
Exclusion criteria:
Patients who have high blood pressure and do not need inotropes
Hemodynamically unstable patients who will undergo organ donation surgery in less than 6 hours
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
For the randomization of patients who meet the inclusion criteria, the method of four blocks including intervention and control groups will be used.The preparation of randomization sequences will be done using the Random Generator software and the created sequences will be given to a trained staff member of the intensive care of unit who is not a member of the research group.The researchers of this study will not be aware of the existing sequences and arrangement of the blocks.After the patient enters the operating room, the trained person removes the first sequence from the special box of this study and according to the predetermined protocol, if it is T, it will be transferred to the intervention group, and if it is C, it will be transferred to the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients do not know their group. Eligible participants to receive testosterone (group T) or placebo (group C) are determined according to a computerized randomization program.These drugs are prepared in syringes and the same volume and are identified with the patient's name and hospital registration number, and in the special care department, these drugs are given to the nurse caring for the patient who is blind to the assigned groups for injection.Another researcher, who is blinded to the assigned groups, will evaluate the hemodynamic status of the patient.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Sina Hospital
Street address
Sina Hospital, Imam Khomeini st.
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2023-05-09, 1402/02/19
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1402.021
Health conditions studied
1
Description of health condition studied
brain dead
ICD-10 code
G96.8
ICD-10 code description
Other specified disorders of central nervous system
Primary outcomes
1
Description
Dosage of noradrenaline
Timepoint
At the beginning of the patient's entry into the study and 8 hours after drug injection
Method of measurement
milliliters per hour
2
Description
Peripheral vascular resistance
Timepoint
At the beginning of the patient's entry into the study and 8 hours after drug injection
Method of measurement
By Ultrasonic Cardiac Output Monitor
Secondary outcomes
1
Description
Cardiac output
Timepoint
At the beginning of the patient's entry into the study and 8 hours after drug injection
Method of measurement
By Ultrasonic Cardiac Output Monitor
2
Description
Cardiac Index
Timepoint
At the beginning of the patient's entry into the study and 8 hours after drug injection
Method of measurement
By Ultrasonic Cardiac Output Monitor
Intervention groups
1
Description
Intervention group: 100 mg of testosterone enanthate drug (manufactured by Caspian Tamin Company) was prepared by nurse of the intensive care department according to the grouping of the patient, and after taking a blood sample from the patient, it was injected into the deltoid muscle, the primary variables of the study were recorded and the care routin continues to maintain the patient's hemodynamics, and 8 hours after injection, primary variables will be re-evaluated.
Category
Treatment - Drugs
2
Description
Control group:The placebo drug that is the same volume as the intervention drug (manufactured by Caspian Tamin Company) was prepared by nurse of the intensive care department according to the grouping of the patient, and after taking a blood sample from the patient, it was injected into the deltoid muscle, the primary variables of the study were recorded and the care routin continues to maintain the patient's hemodynamics, and 8 hours after injection, primary variables will be re-evaluated.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Mohammad Reza Khajavi
Street address
Sina Hospital Hassan Abad sq, em mam khomini st.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8555
Fax
+98 21 6634 8551
Email
khajavim@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Central building of Tehran University of Medical sciences, Ghods st., Keshavarz blv.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3686
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khajavi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina hospital Hassan Abad Sq, Imam khomeni St,
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
+98 21 6634 8553
Email
KHAGAVIM@TUMS.AC.IR
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khajavi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina hospital Hassan Abad Sq, Imam khomeni St,
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
+98 21 6634 8553
Email
khajavim@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
Mohammad Reza Khajavi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina hospital ,Hasan Abad Sq, Imam khomeni St,
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
+98 21 6634 8553
Email
KHAGAVIM@TUMS.AC.IR
Web page address
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Main study outcome data
When the data will become available and for how long
Six months after the end of the study
To whom data/document is available
University researchers
Under which criteria data/document could be used
Share experiences to increase the knowledge
From where data/document is obtainable
khajavim@tums.ac.ir -Dr.khajavi
What processes are involved for a request to access data/document
The request will be made by email and the answer will be given within two months