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Evaluation of the effect of hypertonic saline 3%in the treatment of ECG changes and other side effects of tramadol toxicity

Protocol summary

Study aim
Evaluation of the effect of hypertonic saline3% in the treatment of ECG changes and other side effects of tramadol toxicity
Design
Randomized trial with not blinded in 200 patients ,there is no cotrol group,phase 2-3 on all of the patients
Settings and conduct
Evaluation of the effect of hypertonic saline3% in tramadol side effects with ECG changes in emergency ward of Besat hospital in Tehran
Participants/Inclusion and exclusion criteria
Inclusion criteria: acute tramadol poisoning; aged over 18 years. Exclusion criteria: severe disorders such as liver cirrhosis, the existence of previous diseases such as dextrocardia or behevioral disorders.
Intervention groups
Effect of hypertonic saline 3%in tramadol side effects in all of the patients,there is no control group
Main outcome variables
Drug dose,QRS widening,long QT,tall R,RBBB,axis deviation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220213054017N1
Registration date: 2022-03-21, 1401/01/01
Registration timing: registered_while_recruiting

Last update: 2022-03-21, 1401/01/01
Update count: 0
Registration date
2022-03-21, 1401/01/01
Registrant information
Name
Ebrahim Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 3089
Email address
ebrahimkarimi86@ ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of hypertonic saline 3%in the treatment of ECG changes and other side effects of tramadol toxicity
Public title
Effect of hypertonic saline3% in tramadol toxicity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acute tramadol toxicity Aged over 18 years
Exclusion criteria:
Severe disorders such as liver cirrhosis Existence of previous diseases such as dextrocardia or behavioral disorders
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
IR.AJAUMS.REC
Street address
No. 26,Abgari Ave,Kaj Squ,Saadat abad Blvd,Tehran
City
Tehran
Province
Tehran
Postal code
1998656781
Approval date
2021-08-15, 1400/05/24
Ethics committee reference number
IR.AJAUMS.REC.1400.126

Health conditions studied

1

Description of health condition studied
Acute tramadol toxicity and side effects
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
QRS widening,QT prolongation,RBBB,Tall R,Axis deviation
Timepoint
Before and one hour after treatment with hypertonic saline3%
Method of measurement
ECG

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For patients with ECG changes 3cc/ kg saline 3% is given and one hour later the amount of ECG changes is checked
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat hospital and loghman hospital
Full name of responsible person
Ebrahim Karimi
Street address
No.26,Abgari Ave,Kaj Squ,Saadat abad Blvd,Tehran
City
Tehran
Province
Tehran
Postal code
1998656781
Phone
+98 21 2235 3089
Email
Ebrahimkarimi86@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr.Mojtaba Yusefi
Street address
No.1,West Fatemi Ave.,Etemadzade Ave.,AJA University,tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
Ebrahimkarimi86@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Ebrahim Karimi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Education
Street address
West Fatemi.,Etemadzade Ave.,AJA university
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
009886096350
Email
Ebrahimkarimi86@ gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Ebrahim Karimi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Education
Street address
No.1,West Fatemi Ave.,Etemadzade Ave.,Aja university.,Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 86430
Email
Ebrahimkarimi86@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Ebrahim Karimi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Education
Street address
No.1,West Fatemi Ave.,Etemadzade Ave.,Aja university.,Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 86430
Email
Ebrahimkarimi86@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
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 can be shared after people are not identified
When the data will become available and for how long
Access started in 1402
To whom data/document is available
Researchers working in universities and hospitals
Under which criteria data/document could be used
For further research and change the therapeutic dose of the drug for greater effectiveness of the drug
From where data/document is obtainable
Correspond with the e- mail of the responsible authur ,Ebrahimkarimi86@gmail.com,or call the mobile number,00989124544838
What processes are involved for a request to access data/document
If a research proposal is submitted ,the data will be provided to the applicant within one month
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