Evaluation of the efficacy of high dose corticosteroid regimen for treatment of postoperative high degree Atrioventricular block after valvular cardiac surgery ; A single blind randomized clinical trial
Evaluation of the efficacy of short-term high-dose steroid treatment regimen in recovery time-frame of advanced AV blocks following heart valve surgeries
Design
Each subject has a unique identification code .Demographic features and history of underlying diseases will be obtained from medical history and lab data.
This clinical trial is a phase 3 investigation.
Prior assessments indicate to the chance of spontaneous recovery of AV block after 5 and 7 days of surgery about 80 and 94 % ,respectively. The target or clinical outcomes defined as achieving the goal of 7 days recovery within a 5 day cut point. The sample size calculated based on an alpha error of 0.05 and power estimate of 80 % was 150 subjects with 75 patients in each group.
Settings and conduct
The present study will be conducted in surgery associated wards of Tehran heart center
Participants/Inclusion and exclusion criteria
Presence of advanced atrioventricular block following heart valve surgery including valve replacement or repair with or without CABG; Exclusion of patients having cardiac pacemakers ,ICD or CRT ; prior advanced AV block; recent myocardial infarction or CPR during last week ; diabetics with uncontrolled hyperglycemia ; patients with active infections;immune deficiency ; patients with history of hypersensitivity to steroids; persistent or permanent atrial fibrillation
Intervention groups
Therapeutic intervention is defined as administration of 0.4 mg per kg of intravenous dexamethasone (maximum dose of 35 mg per day) with divided regimen for 3 consecutive days. Standard treatment (for controls) is close observation accompanied with TPM support for all patients(if necessary).
Main outcome variables
1.Frequency of recovery of AV block 5 days after cardiac surgery in percents 2. Comparison of the time of AV block between 2 groups (hours)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180430039488N1
Registration date:2019-03-28, 1398/01/08
Registration timing:registered_while_recruiting
Last update:2019-03-28, 1398/01/08
Update count:0
Registration date
2019-03-28, 1398/01/08
Registrant information
Name
Farzad Masoudkabir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9600
Email address
fmasoudkabir@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-25, 1398/01/05
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of high dose corticosteroid regimen for treatment of postoperative high degree Atrioventricular block after valvular cardiac surgery ; A single blind randomized clinical trial
Public title
Efficacy of steroid treatment on heart blocks secondary to heart valve surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of advanced atrioventricular block following heart valve surgery including valve replacement or repair with or without CABG
Written documented informed consent
Exclusion criteria:
Exclusion of patients having cardiac pacemakers or intracardiac defibrilator-cardiovertor or CRT
Exclusion of subjects having prior advanced AV block with underlying congenital or acquired etiologies or known brady-arrhythmia
Exclusion of patients with acute or recent myocardial infarction or CPR during last week (or survivors of aborted sudden cardiac death)
Exclusion of diabetics with uncontrolled hyperglycemia ( BS>200 in 2 or more measurements out of 4 samples during last 24 hours or HbA1C>9, ketoacidosis or hyperglycemic hyperosmolar state)
Exclusion of patients with active infections
Exclusion of patients with immune deficiency disorders including malignancies and HIV-AIDS,....
Exclusion of patients with prior history of hypersensitivity reactions to steroids
Exclusion of patients with persistent or permanent atrial fibrillation (AF for more than 24 hours except transient or paroxysmal cases)
Age
From 15 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
permuted block randomization containing 4 subjects in each block eg : AABB. A refers to intervention group and B refers to controls.
Blinding (investigator's opinion)
Single blinded
Blinding description
Collected data of the study will be entered in the SPSS and then analysed by an independent expert from THC research institute.
Placebo
Not used
Assignment
Parallel
Other design features
patients in control group receive standard medical care including TPM and monitoring while the others in intervention group receive corticosteroid regimen in addition to standard treatment.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Ghods.street, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
3135674193
Approval date
2018-09-08, 1397/06/17
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.403
Health conditions studied
1
Description of health condition studied
Advanced atrioventricular block following heart valve surgery
ICD-10 code
144.1
ICD-10 code description
Atrioventricular and left bundle-branch block
Primary outcomes
1
Description
Frequency or recovery of AV block
Timepoint
5days
Method of measurement
Duration of AV block in hours and percentage of recovery after 5 days.
Secondary outcomes
1
Description
Incidence rate of of PPM implantation
Timepoint
One month
Method of measurement
Observation and follow-up.Percentage of patients in each group who ultimately undergone PPM implantation
Intervention groups
1
Description
Intervention group: Administration of intravenous dexamethasone with dose of 0.4 mg per kg (maximum dose of 35 mg per day) in divided schedule for 3 consecutive days. All patients including control group have the support of temporary pacemaker and standard conservative treatments.
Category
Treatment - Drugs
2
Description
Control group: This group will receive standard treatment protocol including close monitoring of rhythm with support of a Temporary pace maker
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran heart center
Full name of responsible person
Farzad Masoudkabir
Street address
Jala-al-ahmad highway- North Kargar street
City
Tehran
Province
Tehran
Postal code
3135674193
Phone
+98 21 8802 9600
Fax
Email
fmasoudkabir@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Saeed sadeghian MD
Street address
Jala-Al-ahmad highway .North Kargar street
City
Tehran
Province
Tehran
Postal code
3135674193
Phone
+98 21 8802 9600
Email
fmasoudkabir@sina.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 Heart Center
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
Farzad masoud kabir
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
North Kargar street,Jala-AL ahmad highway-
City
Tehran
Province
Tehran
Postal code
3135674193
Phone
+98 21 8802 9600
Email
Fmasoudkabir@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saeed Ghodsi
Position
Cardiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Jala-AL ahmad highway- North Kargar street
City
Tehran
Province
Tehran
Postal code
3135674193
Phone
+98 21 8802 9600
Email
Dsaeedgh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saeed ghodsi
Position
Cardiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
North Kargar street Jala-AL ahmad highway-
City
Tehran
Province
Tehran
Postal code
3135674193
Phone
+98 21 8802 9600
Email
Dsaeedgh@gmail.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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Particular parts of the data will be released
When the data will become available and for how long
After release of the results
To whom data/document is available
Scientific institutions
Under which criteria data/document could be used
Further analysis
From where data/document is obtainable
Dr Saeed Ghodsi
What processes are involved for a request to access data/document