The effect of magnesium sulfate on the prevention of pancreatitis after endoscopic rollback
Design
In this research, 270 patients with an indication of ERCP referring to Imam Khomeini Hospital will be selected randomly using random numbers table.
Settings and conduct
After performing ERCP, intervention group will receive IV magnesium sulfate and control group will receive IV placebo (normal saline). Patients will be examined after ERCP, and if they have pain according to pancreatitis, an amylase and lipase test will be performed for them.The study is double blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years
Exclusion criteria: Renal failure; Heart block; Myasthenia gravis; Bradycardia; Pregnancy and lactation; Cirrhosis; Kidney stones; Sensitivity to magnesium..
Intervention groups
Intervention group: 2 g IV magnesium sulfate one hour before ERCP and 2 grams six hours after ERCP.
Control group: 2 g of IV placebo (normal saline) one hour before ERCP and 2 g six hours
Main outcome variables
Incidence of pancreatitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180310039017N1
Registration date:2018-04-01, 1397/01/12
Registration timing:prospective
Last update:2018-04-01, 1397/01/12
Update count:0
Registration date
2018-04-01, 1397/01/12
Registrant information
Name
hoda hamid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3441 1585
Email address
h-hamid@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-20, 1397/01/31
Expected recruitment end date
2018-08-22, 1397/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of magnesium sulfate on prevention of pancreatitis after ERCP (Endoscopic retrograde cholangiopancreatography)
Public title
Effect of magnesium sulfate in prevention of pancreatitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Exclusion criteria:
Renal failure GFR <60
Heart block
Myasthenia gravis or other Neuromuscular diseases
Pregnancy and lactation
Bradycardia
Cirrhosis
kidney stones (calcium, magnesium, ammonium, phosphate)
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
270
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, using random numbers table that will be done individually.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding will be done by encoding the pharmaceutical packs.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Central building of Tehran University of Medical Sciences, Qods street, Keshavarz Boulevard.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-12-18, 1396/09/27
Ethics committee reference number
IR.TUMS.IKHC.REC.1396.4292
Health conditions studied
1
Description of health condition studied
Pancreatitis
ICD-10 code
K85
ICD-10 code description
Acute pancreatitis
Primary outcomes
1
Description
Incidence of pancreatitis
Timepoint
After ERCP
Method of measurement
Examination by a physician and performing tests.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 2 g IV magnesium sulfate one hour before ERCP and 2 grams six hours after ERCP.
Category
Prevention
2
Description
Control group: 2 g of IV placebo (normal saline) one hour before ERCP and 2 g six hours after ERCP.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Dr. Hoda Hamid
Street address
Imam Khomeini Hospital Complex, The end of Keshavarz boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6691 1293
Email
h-hamid@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Younesian
Street address
Central building of Tehran University of Medical Sciences, Qods Street, Keshavarz Boulevard.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6119 0000
Email
h-hamid@razi.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
Dr. Hoda Hamid
Position
Internist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital Complex, end of Keashavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6691 1293
Email
h-hamid@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hoda Hamid
Position
Internist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital Complex, end of Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6691 1293
Email
h-hamid@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hoda Hamid
Position
Internist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital Complex, end of Keshavarz Boulevard.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6691 1293
Email
h-hamid@razi.tums.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
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
The main outcomes' data, including testing, interventions and results of intervention will be shared.
When the data will become available and for how long
Access starts after the publication of the results.
To whom data/document is available
Researchers of academic institutions
Under which criteria data/document could be used
Presenting a Introduction letter from the University
From where data/document is obtainable
E-mail: h-hamid@razi.tums.ac.ir Dr. Hoda Hamid
What processes are involved for a request to access data/document
After receiving the request and the introduction letter, Tehran University of Medical Sciences will get permission and the file will be sent to them.