The effect of aggressive hydration with Lactated Ringer’s solution during and post endoscopic retrograde cholangiopancreatography(ERCP) in prevention of post-ERCP pancreatitis (PEP)
Phase 2
Recruiting
- Conditions
- Post ERCP pancreatitis.Other acute pancreatitisK85.8
- Registration Number
- IRCT20221228056959N1
- Lead Sponsor
- Ahvaz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Patients who urdergo ERCP for the first time
Age 18 to 75 years
Patient consent to participate in the study
Exclusion Criteria
Age over 75 years
Concomitant acute pancreatitis
History of gastrectomy surgery (Billroth II surgery) or reconstruction with Roux-en-Y method
History of severe cardiovascular, liver, kidney and respiratory diseases or electrolyte disorders: class II heart failure based on NYHA criteria, recent myocardial ischemia (in the past three months); Cirrhosis of the liver; Renal failure with increased creatinine clearance < 40 mL/min; chronic obstructive pulmonary disease (COPD) requiring oxygen (oxygen saturation < 90%); Hypernatremia (serum sodium > 150 mEq/L) or hyponatremia (serum sodium < 130 mEq/L)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Amylase. Timepoint: Measurement of serum amylase at the beginning and at 2, 8 and 24 hours after ERCP. Method of measurement: Serum amylase measurement laboratory kit.;Epigastric pain. Timepoint: For 24 hours after ERCP. Method of measurement: Visual Analogue Scale.
- Secondary Outcome Measures
Name Time Method Severity of pancreatitis. Timepoint: Examination of the patient in terms of the severity of pancreatitis every eight hours up to 48 hours. Method of measurement: Atlanta classification.;Volume overload. Timepoint: Once every eight hours up to 48 hours. Method of measurement: Lung auscultation.;Bleedind. Timepoint: Once every eight hours up to 48 hours. Method of measurement: Hematemesis or melena in examination and hemoglobin drop in laboratory tests.;Pleural effusion. Timepoint: Up to 48 hours after ERCP. Method of measurement: Chest X-Ray.