To compare intense hydration and fluid standard therapy before and after of ERCP in the prevention of post ERCP pancreatitis
Design
In this study, 160 patients have been assigned to two groups of intervention and control by using random numbers table.
Settings and conduct
In this clinical trial, all patients who undergo ERCP in Ayatollah Rouhani Hospital with diagnosis of common bile duct stone (uncomplicated) diagnosis include the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria includes all patients over 18 years who were referred to hospital for ERCP. Patients disorders in liver function tests or had extrahepatic cholestasis. Exclusion criteria include history of PEP and Pancreatitis with Other Pancreatic Risk Factors and Diseases, Heart Failure, IBD, NSAID Allergy, Coagulation Disorders, Chronic renal failure
Current hypotension (eg septic shock), Severe liver failure, Respiratory failure, Pregnancy, Hyponatremia or Hypnothermia, Edema or ascites, Using high-risk outside the stone during the ERCP procedure.
Intervention groups
One group was treated with ringer lactat serum and another group with Standard fluid therapy.
Main outcome variables
Pancreatitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191226045897N1
Registration date:2020-02-22, 1398/12/03
Registration timing:retrospective
Last update:2020-02-22, 1398/12/03
Update count:0
Registration date
2020-02-22, 1398/12/03
Registrant information
Name
Seyed Hassan Abedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8269
Email address
h.abedi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-01, 1397/02/11
Expected recruitment end date
2019-05-01, 1398/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
TO compare intense hydration and fluid standard therapy before and after of ERCP in the prevention of post ERCP pancreatitis
Public title
Compare intense hydration and fluid standard therapy before and after of ERCP in the prevention of post ERCP pancreatitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients over 18 years who were referred to hospital for ERCP.
Patients disorders in liver function tests or had extrahepatic cholestasis.
Exclusion criteria:
History of PEP and Pancreatitis with Other Pancreatic Risk Factors and Diseases
Heart Failure
IBD
NSAID Allergy
Coagulation Disorders
Chronic renal failure
Current hypotension (eg septic shock)
Severe liver failure
Respiratory failure
Pregnancy
Hyponatremia or Hypnothermia
Edema or ascites
Using high-risk outside the stone during the ERCP procedure
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
These patients were randomly divided into two groups of 80 aggressive fluid therapy before and after ERCP and standard fluid therapy before and after ERCP.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Approval date
2018-05-01, 1397/02/11
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.179
Health conditions studied
1
Description of health condition studied
Acute Pancreatitis
ICD-10 code
k85.8
ICD-10 code description
Other Acute Pancreatitis
Primary outcomes
1
Description
Pancreatitis
Timepoint
24 hours after ERCP
Method of measurement
Amylase serum, Patient's symptoms(nausea, vomiting and abdominal pain)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ringer's lactate serum was infused at a rate 1.5 times the standard limit of 4.5 cc / h before ERCP (approximately 3200 cc over 12 h with a mean weight of 60 kg) and at and after this rate. will continue.
Category
Prevention
2
Description
Control group: During and after the liquid ERCP second group received standard treatment (/ 5CC / kg / hr1 to 12 hours later).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Ayatollah Rouhani Hospital
Full name of responsible person
Dr. sayed Hassan abedi
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
47156329865
Phone
+98 11 3223 8301
Email
h.abedi@mubabol.ac.ir
Web page address
http://www.mubabol.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Reza Ghadimi
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Web page address
http://www.mubabol.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr. Bahareh Enjilala
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3223 8301
Email
h.abedi@mubabol.ac.ir
Web page address
https://www.mubabol.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Sayed Hassan Abedi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Babol University of Medical Sciences; Ganjafrooz street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3223 8301
Email
h.abedi@mubabol.ac.ir
Web page address
https://www.mubabol.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Sayed Hassan Abedi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3223 8301
Email
h.abedi@mubabol.ac.ir
Web page address
https://www.mubabol.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD