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The effect of aortic root infusion of Dexmedetomidine before de-clamping of the aorta on myocardial protection in patients undergoing Mitral valve replacement/ repair

Protocol summary

Study aim
Evaluating the effect of dexmedetomidine infusion in the aortic root before aortic cross clamp removal on myocardial protection in patients undergoing mitral valve replacement / repair.
Design
A controlled clinical trial with superiority, with parallel groups, three-way blind, randomized block method, phase 3 on 58 patients, www.randomization.com is used for randomization.
Settings and conduct
Patients scheduled for mitral valve repair or replacement were randomly assigned to either dexmedetomedine or placebo group. Before entering the operating room, blood samples will be sent to all patients to test for troponin I and creatinine kinase-MB. Within 6 hours of entering the Intensive Care Unit, 12 hours later and 24 hours after entering the Intensive Care Unit, the sample will be repeated and the results will be recorded. Also, patients' urinary output is recorded in the first 6 hours, the first 12 hours and 24 hours after surgery.
Participants/Inclusion and exclusion criteria
The study population included patients seeking mitral valve repair or replacement with a ejection fraction above 40%, and no history of supraventricular dysrhythmias, no history of cardiac surgery, nephropathy following the use of contrast agents (CIN), respiratory failure, Stroke and TIA, And coagulopathy.
Intervention groups
At the end of the surgical procedure, before removing the aortic clamp, at the root of the aorta of patients, using a cardioplegia needle, a solution of dexmedetomidine with a concentration of 4 μg / ml, at a rate of 1 μg / kg / h, for 10 minutes, Is infused. At the end of the surgical procedure, before removing the aortic clamp, in the aortic root of patients, using a cardioplegia needle, 0.9% sodium chloride solution at a rate of 1 ml / kg / hour for 10 minutes infusion will be.
Main outcome variables
Troponin and CPK-MB changes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210710051837N1
Registration date: 2021-10-18, 1400/07/26
Registration timing: registered_while_recruiting

Last update: 2021-10-18, 1400/07/26
Update count: 0
Registration date
2021-10-18, 1400/07/26
Registrant information
Name
Fateme Hajipour aghmashhadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3328 0646
Email address
hajipouraf981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2021-11-16, 1400/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aortic root infusion of Dexmedetomidine before de-clamping of the aorta on myocardial protection in patients undergoing Mitral valve replacement/ repair
Public title
The effect of Dexmedetomidine on myocardial protection in patients undergoing Mitral valve replacement/ repair
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for mitral valve repair or replacement with ejection fraction above 40%
Exclusion criteria:
Supraventricularor ventricular dysrhythmias History of heart surgery Nephropathy following the use of contrast agent (CIN) Hypercapnic or hypoxic Respiratory failure Patients with a history of Stroke and TIA Patients with a history of Coagulopathy Use of an intra-aortic balloon pump (IABP) before and during surgery Use of vasopressor before surgery Patient dissatisfaction to participate in the study The presence of any pathological disorder leads to the release of inflammatory cytokines Cardiopulmonary arrest before, during and after surgery
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
The randomized block method and using the site www.randomization.com Block: This method is used to prevent significant imbalances in the number of participants assigned to each group. Block randomization ensures that no significant imbalance is established between groups at any time during randomization, and at certain points the number of participants in each group is equal. For this method, the volume of each block must first be determined ( Example of a quadruple block). Then write a list of blocks and assign numbers to them (AABB (1) - ABAB (2) -ABBA (3) -BBAA (4) - BABA (5) - BAAB (6)) Then select random numbers between one and 6 (Eg 1 4 5 and ...) and finally specify the treatment allocation list based on previous random numbers (AB AABB-BBAA-BABA-).} Allocation Concealment Allocation Method: The lottery is done using the envelope in the package.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Subjects, Evaluators and Analysts will be unaware of the solutions administered to the aortic roots of the intervention and control groups. As we will define the syringe containing the solutions with the labels A and B, and the Subjects, Evaluators and Analysts are not aware of the contents of the syringe.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
East door of the University Campus, Azadi Square, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۵۶۴
Approval date
2021-07-12, 1400/04/21
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.186

Health conditions studied

1

Description of health condition studied
The effect of aortic root infusion of Dexmedetomidine before de-clamping of the aorta on myocardial protection in patients undergoing Mitral valve replacement/ repair
ICD-10 code
105.9
ICD-10 code description
Mitral (valve) disorder (chronic) NOS

Primary outcomes

1

Description
Troponin I Assay
Timepoint
Before entering the operating room, In the first hour, 6 hours later, 12 hours later and 24 hours after entering the Intensive Care Unit
Method of measurement
Blood Sample

2

Description
Creatinine kinease _MB Assay
Timepoint
Before entering the operating room, In the first hour, 6 hours later, 12 hours later and 24 hours after entering the Intensive Care Unit
Method of measurement
Blood Sample

3

Description
The rate of urinary outputs
Timepoint
The first 6 hours, the first 12 hours and 24 hours after the operation
Method of measurement
By catheterization and viewing the urinary bag

Secondary outcomes

1

Description
CRP level
Timepoint
Before surgery, 6 hours after entering the Intensive Care Unit, 12 hours after and 24 hours after entering the Intensive Care Unit
Method of measurement
Blood Sample

2

Description
ESR level
Timepoint
Before surgery, 6 hours after entering the Intensive Care Unit, 12 hours after and 24 hours after entering the Intensive Care Unit
Method of measurement
Blood Sample

3

Description
Inotropic Score
Timepoint
In the Intensive Care Unit
Method of measurement
Inotropic score = ([dopamine + dobutamine]×1) + (milrinone×15) + ([epinephrine + norepinephrine + isoproterenol]×100)

Intervention groups

1

Description
Intervention group: At the end of the surgical procedure, before removing the aortic clamp, at the root of the aorta of patients, using a cardioplegia needle, a solution of dexmedetomidine with a concentration of 4 μg / ml, at a rate of 1 μg / kg / h, for 10 minutes, Is infused.
Category
Prevention

2

Description
Control group: At the end of the surgical procedure, before removing the aortic clamp, in the aortic root of patients, using a cardioplegia needle, 0.9% sodium chloride solution at a rate of 1 ml / kg / hour for 10 minutes infusion will be.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Heart Surgery Center, Mashhad, Iran
Full name of responsible person
Fateme Hajipour Aghmashhadi
Street address
Imam Research and Treatment Center, Imam Reza Hospital Square, Ibne Sina St, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
IRH@mums.ac.ir

2

Recruitment center
Name of recruitment center
Razavi Heart Surgery Center, Mashhad, Iran
Full name of responsible person
Fateme Hajipour Aghmashhadi
Street address
Razavi Hospital, after Ghaem Bridge, Azadi Highway, Mahhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۹۸۶۱۳۶۸۱
Phone
+98 51 3666 8888
Email
info@razavihospital.ir

3

Recruitment center
Name of recruitment center
Shahid Rajaei Heart Surgery Center, Tehran, Iran
Full name of responsible person
Fateme Hajipour Aghmashhadi
Street address
Shahid Rajaei Cardiovascular Training, Research and Treatment Center, next to Mellat Park- corner of Niayesh, Vali Asr St., Tehran Town
City
Tehran
Province
Tehran
Postal code
۱۹۹۵۶۱۴۳۳۱
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
NCRC@iums .ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fateme Hajipour Aghmashhadi
Street address
University St, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
۱۳۹۴۴۹۱۳۸۸
Phone
+98 51 3841 2081
Fax
+98 51 3841 3006
Email
presidentoffice@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Fateme Hajipour Aghmashhadi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
perfusion
Street address
Edalat Alley, Aghapour Alley, Shahid Ghasemi Ave, Emam Reza Blvd, Sari Town
City
Sari
Province
Mazandaran
Postal code
4817987548
Phone
+98 11 3328 0646
Email
Hajipour_atena@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fateme Hajipour aghmashhadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Perfusion
Street address
Edalat alley, Shahid Ghasemi Ave, Emam Reza blvd, Sari Town
City
Sari
Province
Mazandaran
Postal code
4817987548
Phone
+98 11 3328 0646
Fax
Email
Hajipour_atena@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fateme Hajipour aghmashhadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Perfusion
Street address
Edalat alley, Shahid Ghasemi Ave, Emam Reza blvd, Sari Town
City
Sari
Province
Mazandaran
Postal code
4817987548
Phone
+98 11 3328 0646
Fax
Email
Hajipour_atena@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Will be published as an article
When the data will become available and for how long
One year
To whom data/document is available
Researchers and Experts
Under which criteria data/document could be used
it would be possible after getting permission from undersecretary of research
From where data/document is obtainable
send email to Hajipouraf981@mums.ac.ir
What processes are involved for a request to access data/document
After requesting, the file will be sent in Excel or Spss.
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