The aim of this study is to evaluate the therapeutic effect of fluconazole on acute biliary pancreatitis. The desired number of samples, 76 patients with acute biliary pancreatitis admitted to Imam Reza Hospital are selected and they are divided into two groups through Table of random numbers. In one group the routine treatment is performed(included Restriction of oral intake, correction of water and electrolyte, pain management, intravenous fluids and monitoring of central venous pressure, urine output controls the prescription of prophylactic antibiotics) and in other group, Fluconazole is added to the treatment regimen. Agreement form is completed for all patients and Patients are not aware of being in the fluconazole group or standard treatment. Inclusion criteria: consists of those who have been diagnosed with acute biliary pancreatitis based on clinical; laboratory and ultrasound results.criteria excluded: Pregnant women; patients with a history of previous hypersensitivity to fluconazole to mention; person that any allergies or suffer from the study. The severity of disease in patients is determined based on Ransom criteria on admission or CT Scan. Mild cases are cared in general ward and severe cases are hospitalized or admitted in the intensive care unit. Ransom criteria and serum amylase levels will be recalculated at 48 h after admission.
Patients in both groups are evaluated in terms of complications, requiring to necrosectomy surgery, hospital stay duration, staying in the intensive care unit and cost of hospitalization.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013082714333N3
Registration date:2013-09-23, 1392/07/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-23, 1392/07/01
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-11-21, 1392/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
copmarsion of treatment effects with and without the use of Fluconazole on acute biliary pancreatitis
Public title
Evaluation of Fluconazole treatment effects on acute biliary pancreatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:patients consists of those who have been diagnosed with acute biliary pancreatitis based on clinical; laboratory and ultrasound results.criteria excluded: Pregnant women; patients with a history of previous hypersensitivity to fluconazole to mention; person that any allergies or suffer from the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
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
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2013-05-18, 1392/02/28
Ethics committee reference number
7206/پ/7/420
Health conditions studied
1
Description of health condition studied
biliary acute pancreatitis
ICD-10 code
k85.1
ICD-10 code description
biliary acute pancreatitis
Primary outcomes
1
Description
Severity of disease
Timepoint
at starting point and six months later
Method of measurement
Based on Ratson criteria and CT. Scan
2
Description
necessity to operation
Timepoint
at starting point and 6 months later
Method of measurement
based on patient records
3
Description
duration of staying in hospita
Timepoint
at starting point and 6 months later
Method of measurement
based on patient records
4
Description
duration of staying in hospital
Timepoint
at starting point and 6 months later
Method of measurement
based on patient records
5
Description
costs of disease
Timepoint
at starting point and 6 months later
Method of measurement
based on patient records
6
Description
treatments
Timepoint
at starting point and 6 months later
Method of measurement
based on patient records
7
Description
complications
Timepoint
at starting point and 6 months later
Method of measurement
based on patient records
8
Description
mortality rate
Timepoint
at starting point and 6 months later
Method of measurement
based on patient records
Secondary outcomes
empty
Intervention groups
1
Description
routine treatment (included Restriction of oral intake, correction of water and electrolyte, pain management intravenous fluids and, monitoring of central venous pressure, urine output controls the prescription of prophylactic antibiotics) to control group
Category
Treatment - Drugs
2
Description
Fluconazole is added to the treatment regimen for five days in the intervention group