The effect of routine rhabdomyolysis treatment with and without concomitant administration of Montelukast on the stop progression and recovery time of rhabdomyolysis
Determining the effect of routine rhabdomyolysis treatment with and without concomitant administration of Montelukast on rhabdomyolysis recovery or stop progression in patients of Poisoned ward of Tehran Loghman-Hakim Hospital.
Design
Clinical trial with control group with parallel groups of phase 1 randomized blind blind on 60 patients. Rand function of Excel software was used for randomization.
Settings and conduct
Patients with rhabdomyolysis (CPK> 1000) will be selected in the poison ward of Loghman-Hakim Hospital in Tehran and will be written in order, and odd numbers will be included in the control group and even numbers will be included in the target group.Control group Will receive routine treatment of rhabdomyolysis by hydration,bicarbinate and placebo but the target group will receive routine treatment and oral Montelukast or gavage at a dose of 10 mg twice daily.Daily check of CPK and Cr enzymes and comparison of increasing or decreasing changes and decreasing or ascending course of the above enzymes in the two groups and examining the results of these changes and the significance or not of these statistics in the effectiveness of concomitant administration of Montelukast in rhabdomyolysis will be evaluated and concluded. Was
Participants/Inclusion and exclusion criteria
Patients who admitted to the Poison ward of Loghman-Hakim Hospital who have suffered from rhabdomyolysis and do not have kidney disease or diabetes
Intervention groups
Poisoned patients with rhabdomyolysis(cpk> 1000) are divided into control and target groups and the control group is treated only with hydration, bicarbonate and placebo, but in addition to the above treatment, Montelukast is also prescribed to the target group.
Main outcome variables
The rate of decline of rhabdomyolysis. Reduce cpk
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210720051946N2
Registration date:2022-05-19, 1401/02/29
Registration timing:prospective
Last update:2022-05-19, 1401/02/29
Update count:0
Registration date
2022-05-19, 1401/02/29
Registrant information
Name
Peyman Erfan Talab Evini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5102 5000
Email address
peyman1346erfan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-06-10, 1401/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of routine rhabdomyolysis treatment with and without concomitant administration of Montelukast on the stop progression and recovery time of rhabdomyolysis
Public title
The effect of Montelukast administration on rhabdomyolysis state
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients that admit with drug or substance toxicity and progress to rhabdomyolysis
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Through the table of numbers: 60 patients who have enough criteria for participation in this plan are written from number one to 60 then even numbers enter the intervention group and odd numbers enter the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
For this study, patients with rhabdomyolysis (CPK> 1000) was selected from poisoning ward at Loghman Hakim Hospital in Tehran and divided into control and target groups:
1-Control group will receive routine rhabdomyolysis treatment by hydration therapy and bicarbonate therapy
2- Target group will receive hydration therapy with oral Montelukast or gavage at a dose of 10 mg twice daily.
In this study, patients or their companions who enter the study are given consent to prescribe a new drug, but the control and target groups remain unaware of the type of treatment received and are kept blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Aarabi Ave.,Velenjak.,Tehran City
City
Tehran
Province
Tehran
Postal code
1333635445
Approval date
2021-06-22, 1400/04/01
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.441
Health conditions studied
1
Description of health condition studied
Rhabdomyolysis
ICD-10 code
M62.82
ICD-10 code description
Rhabdomyolysis
Primary outcomes
1
Description
Cpk
Timepoint
Daily
Method of measurement
Labratory
Secondary outcomes
empty
Intervention groups
1
Description
Control group:Includes odd numbers in the numbered list of patients undergoing routine rhabdomyolysis (24-hour maintenance fluid therapy plus one liter of Normal saline per 1000 units of Cpk increase above 1000) while maximal normal saline is added intake is 4 liters in 24 hours. In cases of Cpk> 5000 , patients will receive only an infusion of 200 cc of 5% dextrose serum with 30 milliequivalents of Sodium bicarbonate per hour.Nephrology consultation will be performed for all patients and according to the Nephrologist, the patients who are candidates for dialysis for any reason will be removed from the plan and another patient will be replaced.
Category
N/A
2
Description
Intervention group: Includes even numbers in the numbered list of patients receiving treatment in the control group, but in addition, Montelukast tablets are taken as 10 mg every 12 hours orally or by gavage until the Cpk is reduced to less than 1000. This group patients, like the control group, if for any reason, according to the Nephrologist, are candidates for dialysis, they will be excluded from the plan and another patient will be replaced.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Poisoned ward of Loghman-Hakim hospital
Full name of responsible person
Peyman Erfantalab Avini
Street address
Special street., Loghman Hakim Hospital
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5102 5000
Email
peyman1346erfan@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarbi
Street address
No. 2, Shahid Aarabi St.,, Yemen St., Shahid Chamran Highway., Tehran city
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 2243 9780
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Peyman Erfantalab Avini
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Toxicology
Street address
Special Ave., Tehran city
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5102 5000
Email
peyman1346erfan@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Peyman Erfantalab Avini
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Toxicology
Street address
Special Ave., Tehran city
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5102 5000
Email
peyman1346erfan@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Peyman Erfantalab Avini
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Toxicology
Street address
Special Ave., Tehran city
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5102 5000
Email
peyman1346erfan@sbmu.ac.ir
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
Undecided - It is not yet known if there will be 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
Data are age, sex, and test results of the control and target groups, and only part of the data can be shared
When the data will become available and for how long
Access will start from the time the results are printed
To whom data/document is available
Everyone
Under which criteria data/document could be used
Allowed for scientific and medical uses
From where data/document is obtainable
Email:peyman1346erfan@sbmu.ac.ir
What processes are involved for a request to access data/document
Email:peyman1346erfan@sbmu.ac.ir
The applicant states the reason for her request by sending her request to the above email, and then within about two weeks, the general information of the patients without mentioning their names and details and the results of this research will be sent to him.