Evaluation of short term protective effect of aggressive hydration therapy with lactated ringer’s solution on pancreatitis after endoscopic retrograde cholangiopancreatography
150 patient candidate for endoscopic retrograde cholangiopancreatography in 5 months period with inclusion criteria( Choledochobilliary Stone; Dilatation and Obstraction of Choledochobilliary) and without exclusion criteria( Acute Cholangitis; Pregnancy; End Organ Failure; Age above 70 years) divided to two groups, case and control randomizely.That's obvious for researcher exclusively. For case group aggressive hydration and for control group routine hydration therapy will be done. Both groups discontinue intravenous fluids when they are able to eat a normal diet.The aim of this study is evalution of aggressive hydration therapy in prevention of post endoscopic retrograde cholangiopancreatography pancreatitis as primary end point.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410161213N3
Registration date:2014-10-19, 1393/07/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-10-19, 1393/07/27
Registrant information
Name
Manouchehr Khoshbaten
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 7554
Email address
khoshbatenm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research -Tabriz University of Medical Science
Expected recruitment start date
2014-11-06, 1393/08/15
Expected recruitment end date
2015-04-20, 1394/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of short term protective effect of aggressive hydration therapy with lactated ringer’s solution on pancreatitis after endoscopic retrograde cholangiopancreatography
Public title
Effect of aggressive hydration therapy in prevention of complication of endoscopic theraputic intervention on billiary duct.
Purpose
Prevention
Inclusion/Exclusion criteria
(Inclusion criteria:Indication of endoscopic retrograde cholangiopancreaticography; consent of enrollment in study and Exclusion criteria:Acute cholangitis; sepsis; pregnancy; age above 70 years; chronic pancreatitis; acute pancreatitis due to billiary stone; risk of fluid overload; peripheral edema; pulmonary edema; electrolyte disturbance for example Na over 150 or below 130; history of endoscopic retrograde cholangiopancreaticography performation with sphinctrotomy.)
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:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences , affiliated to the Ministry of Health, Treatment and Medical
Street address
Central bulding of medical science university, St. Golgasht, St. Azadi ,Tabriz
City
Tabriz
Postal code
Approval date
2014-10-12, 1393/07/20
Ethics committee reference number
93104
Health conditions studied
1
Description of health condition studied
Pancreatitis
ICD-10 code
K85
ICD-10 code description
Acute pancreatitis
Primary outcomes
1
Description
Post endoscopicretrograde cholangiopancreaticography pancreatitis
Timepoint
2,8 and 24 hours after intervation
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Hyper amylasemia
Timepoint
2, 8 and 24 after intervation
Method of measurement
U/L
2
Description
Pain
Timepoint
2, 8 and 24 after intervation
Method of measurement
Visual analouge pain scale
Intervention groups
1
Description
In case group lactated ringer serum administer with dose of 20 cc per kilogram of body mass and continue with 3 cc per kilogram of body mass until 8 hours.
Category
Treatment - Drugs
2
Description
In control group lactated ringer serum administer with dose of 1.5 cc per kilogram of body mass until 8 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Ali reza shayegan nezhad
Street address
Endoscopy ward, first floor, Imam Reza Hospital, St. Golgasht, St.Azadi
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research -Tabriz University of Medical Science
Full name of responsible person
Dr.Mohammad Reza Rashidi
Street address
Third floor, Central building No.2, Tabriz University of Medical Sciences ,St.Golgasht
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research -Tabriz University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Reza Shaygan nezhad
Position
Gastroentrology and hepatology assistant
Other areas of specialty/work
Street address
Endoscopy ward, first floor, Imam Reza Hospital, St. Golgasht, St.Azadi, Tabriz
City
Endoscopy ward, first floor, Imam Reza Hospital, St. Golgasht, St.Azadi, Tabriz
Postal code
Phone
+98 41 3334 7554
Fax
+98 41 3334 7554
Email
ali.shayegan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Reza Shaygan Nezhad
Position
Gastroentrology and hepatology assistant
Other areas of specialty/work
Street address
Endoscopy ward, first floor, Imam Reza Hospital, St. Golgasht, St.Azadi, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3334 7554
Fax
+98 41 3334 7554
Email
Ali.shayegan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Reza Shaygan Nezhad
Position
Gastroentrology and hepatology assistant
Other areas of specialty/work
Street address
Endoscopy ward, first floor, Imam Reza Hospital, St. Golgasht, St.Azadi, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3334 7554
Fax
Email
ali.shayegan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)