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IRCT20221228056959N1 IRCT 2022-12-31 Ahvaz University of Medical Sciences The effect of aggressive hydration with Lactated Ringer’s solution during and post endoscopic retrograde cholangiopancreatography(ERCP) in prevention of post-ERCP pancreatitis (PEP) The effect of aggressive hydration with Lactated Ringer’s solution during and post endoscopic retrograde cholangiopancreatography(ERCP) in prevention of post-ERCP pancreatitis (PEP) 2022-12-31 anticipated 150 Complete https://irct.ir/trial/67667 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The way of randomization is that people are divided into two groups with equal numbers using random blocks created by the Random allocation software, by a person who is not involved in the study process, Blinding description: Blinding is done in such a way that the person who will perform the randomization and allocation of people to groups, the endoscopist, the patients, the person who evaluates the results, and the person who analyzes the results have no information about the grouping and randomization of patients in the study groups. the study is done in a double-blind manner. An independent specialist doctor who is not involved in this research administers the fluids. 2-3 Post ERCP pancreatitis. Intervention 1: Intervention group: The intervention group recieve aggressive hydration with Ringer's lactate solution 10ml/kg initial bolus before surgery, 3ml/kg/h during ERCP procedure and for 8 hours after procedure, and a post procedure bolus of 10ml/kg. Intervention 2: Control group: The control group received standard hydration with Ringer's lactate solution 1.5 mL/kg/h for 8 hours during and after ERCP. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Hamidreza Zarei
Imam Khomini hospital, Azadegan st.
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61 3222 2922 hamidreza.zarei@yahoo.com Ahvaz University of Medical Sciences scientific Jalal Sayyah
Imam Khomeyni, Azadegan st, Ahvaz
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61 3222 2922 sayah-j@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients who urdergo ERCP for the first time Age 18 to 75 years Patient consent to participate in the study 18 years 75 years Both 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) K85.8 Other acute pancreatitis Prevention Prevention Intervention group: The intervention group recieve aggressive hydration with Ringer's lactate solution 10ml/kg initial bolus before surgery, 3ml/kg/h during ERCP procedure and for 8 hours after procedure, and a post procedure bolus of 10ml/kg. Control group: The control group received standard hydration with Ringer's lactate solution 1.5 mL/kg/h for 8 hours during and after ERCP. 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. 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. Ahvaz University of Medical Sciences Approved 2022-12-13 Research Ethics Committees of Golestan Hospital Golestan Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)