Evaluation of efficacy & safety of aggressive hydration therapy with ringer’s lactated solution on pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in patient candidate for ERCP
The purpose of this study is investigating the effect of aggressive hydration with lactate ringer in preventing acute pancreatitis after Endoscopic retrograde cholangiopancreatography
Design
Study is carried out in a single blind randomized, clinical trial on 164 patients up to 70 year’s old, and candidate Endoscopic retrograde cholangiopancreatography. Patients will be divided into two control and intervention groups by simple random method (closed packet method)
Settings and conduct
Study is carried out in a single blind, one centric clinical trial at Velayat hospital in Qazvin. Patients do not know about the assignment of study groups.
Participants/Inclusion and exclusion criteria
Major Inclusion criteria: Indication of endoscopic retrograde cholangiopancreaticography; consent of enrollment in study. Exclusion criteria: Acute cholangitis; sepsis; pregnancy; chronic pancreatitis; acute pancreatitis due to billiary stone; risk of fluid overload; peripheral edema
Intervention groups
Interventions: Intervention Group: In the case group, Ringer's lactate solution with 20 cc/Kg was administered bolus and then with a dose of 3 cc/Kg during 8 hours after ERCP and in the control group Ringer's lactate solution is given at a dose of 1.5 cc / kg during 8 hours after ERCP. Receiving intravenous fluid in both groups will be interrupted when they are able to eat a normal diet.
Main outcome variables
Main outcome variable: Acute pancreatitis (abdominal pain, serum amylase and lipase) will be assessed at 6, 12 and 24 hours after Intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171009036664N1
Registration date:2018-01-11, 1396/10/21
Registration timing:registered_while_recruiting
Last update:2018-01-11, 1396/10/21
Update count:0
Registration date
2018-01-11, 1396/10/21
Registrant information
Name
Ali Bastani
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3376 0620
Email address
a.bastani@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-31, 1396/10/10
Expected recruitment end date
2018-07-01, 1397/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy & safety of aggressive hydration therapy with ringer’s lactated solution on pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in patient candidate for ERCP
Public title
Evaluation & safety of lactated ringer’s solution on prevention of acute pancreatitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Indication for endoscopic retrograde cholangiopancreaticography (ERCP);
Consent of enrollment in the study
Exclusion criteria:
Acute cholangitis;
Sepsis;
Pregnancy;
Age above 70 years;
Chronic pancreatitis;
Acute pancreatitis due to billiary stone;
evidence of fluid overload;
Peripheral edema;
Pulmonary edema;
Electrolyte disturbance for example Na over 150 or below 130;
Cirrhosis
Renal failure
History of endoscopic retrograde cholangiopancreaticography performation with sphinctrotomy
Age
To 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
164
Randomization (investigator's opinion)
Randomized
Randomization description
simple random method (sealed packet method)
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will be blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2017-02-11, 1395/11/23
Ethics committee reference number
IR.QUMS.REC.1395.268
Health conditions studied
1
Description of health condition studied
Acute pancreatitis
ICD-10 code
K85
ICD-10 code description
Acute pancreatitis
Primary outcomes
1
Description
Post endoscopicretrograde cholangiopancreatography pancreatitis
Timepoint
6, 12 and 24 hours after endoscopicretrograde cholangiopancreatography procedure
Method of measurement
Clinical examination (abdominal pain) & laboratory testing(amylase, and/or lipase levels to ≥3 times the upper limit of normal)
Secondary outcomes
1
Description
Complications of ERCP
Timepoint
6, 12 and 24 hours after endoscopicretrograde cholangiopancreatography procedure
Method of measurement
Clinical examination
Intervention groups
1
Description
Intervention group: serum lactate ringer with 20 cc/Kg was administered bolus and then with a dose of 3 cc/Kg to 8 hours after ERCP
Category
Prevention
2
Description
Control group: Serum lactate ringer is given at a dose of 1.5 cc / kg up to 8 hours after ERCP.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat educational and treatment center
Full name of responsible person
Mahnaz Abbasi
Street address
22 Bahaman Blvd, Minoodar area, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3379 0620
Email
dr_a_b76@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Amir Peymani
Street address
Shahid bahonar blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Email
research@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?