Protocol summary

Summary
This study aims at evaluating the effect of short-aggressive fluid therapy with Ringer solution before ERCP (Endoscopic Retrograde cholangiopancreatography) on the prevention of pancreatitis related to ERCP. 240 samples were evaluates. An inclusion criterion of the study was the indication for endoscopy, etc. Exclusion criteria: Active cholangitis; Age over 70 years; Chronic pancreatitis, etc. A total of 240 samples were estimated that 120 people will be randomly assigned to two groups. For the intervention group, aggressive fluid therapy, a dose of 20 ml / kg of Ringer lactate within 90 minutes before endoscopy And 3 ml/ kg /h is given during ERCP with 3 to 8 mL / kg /h will continue. If there is no pain, it will become 1.5 ml / kg /h. For the control group, 1.5 mL / kg /h during ERCP are Ringer lactate which will continue up to 8 hours after ERCP. For Both groups who received intravenous fluid when they are able to eat a normal diet, it will be cut. Then all patients by way of ERCP (guide wire), will be treated. Upon completion of ERCP, all patients 2, 8 and 24 hours later will be visited by the digestive flow. Review of fluids through clinical examinations will be at or ankle edema, pulmonary crackles, or decreased O2 Saturation. In addition to pancreatitis, two criteria are forming pancreatitis (Hyperamylasemia and Pain) as studied variables.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201608101213N4
Registration date: 2016-09-18, 1395/06/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-09-18, 1395/06/28
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
2016-07-22, 1395/05/01
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing Short-term effects of aggressive hydration therapy with lactated Ringer’s solution before cholangiopancreatography for prevention of complications compared with not using of serum before the Endoscopic retrograde cholangiopancreatography
Public title
The impact of aggressive hydration therapy with lactated Ringer’s solution before procedure on outcomes after Endoscopic Retrograde CholangioPancreatography
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Indication of endoscopic retrograde cholangiopancreatography; Consent of enrollment in study and Exclusion criteria:Acute cholangitis; Sepsis; Pregnancy; Age above 70 years; Chronic pancreatitis; Acute pancreatitis due to biliary stone; Risk of fluid overload; Peripheral edema; Pulmonary edema; Electrolyte disturbance for example Na over 150 or below 130; History of endoscopic retrograde cholangiopancreatography per formation with sphincterotomy.
Age
To 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 240
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Central bulding of medical science university, St. Golgasht, St. Azadi ,Tabriz Tabriz
City
Tabriz
Postal code
Approval date
2016-07-12, 1395/04/22
Ethics committee reference number
IR.TBZMED.REC.1395.289

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 cholangiopancreatography pancreatitis
Timepoint
2,8 and 24 hours after intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Hyper amylasemia
Timepoint
2,8 and 24 hours after intervention
Method of measurement
U/L

2

Description
Pain
Timepoint
2,8 and 24 hours after intervention
Method of measurement
Visual analouge pain scale

Intervention groups

1

Description
For the intervention group, aggressive fluid therapy, a dose of 20 ml / kgof Ringer lactate within 90 minutes before endoscopy And 3 mL / kg /h is given during ERCP with 3 to 8 mL / kg /h will continue.If there is no pain, it will become 5.1 ml / kg /h.
Category
Treatment - Drugs

2

Description
For the control group, 1.5 mL / kg /h during ERCP is Ringer lactate which will continue up to 8 hours after ERCP.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz, Tabriz University of Medical Sciences, Imam Reza Hospital
Full name of responsible person
Dr.Ramin Ghaderi
Street address
Endoscopy ward, first floor, Imam Reza Hospital, St. Golgasht, St.Azadi, Tabriz, East Azarbaijan
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Vice chancellor for Research of Tabriz University of Medical Sciences,Tabriz University of Medical Sciences, Golgasht Street, Tabriz
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 of Tabriz University of Medical Sciences
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
Dr. Manouchehr Khoshbaten
Position
Gastroentrology and hepatology/ Professor
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
Khoshbatenm@tbmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Manouchehr Khoshbaten
Position
Gastroentrology and hepatology/ Professor
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
Khoshbatenm@tbmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Ramin Ghaderi
Position
Gastroentrology and hepatology assistant
Other areas of specialty/work
Street address
Endoscopy ward, first floor, Imam Reza Hospital, St. Golgasht, St.Azadi, Tabriz, East Azarbaijan
City
Tabriz
Postal code
Phone
+98 41 3334 7554
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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