The effect of aggressive hydration with Lactated Ringer’s solution during and post endoscopic retrograde cholangiopancreatography(ERCP) in prevention of post-ERCP pancreatitis (PEP)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20221228056959N1

Enrollment

150

Registered

2022-12-31

Start date

2022-12-31

Completion date

Unknown

Last updated

2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post ERCP pancreatitis. Other acute pancreatitis

Interventions

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 ho

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients who urdergo ERCP for the first time Age 18 to 75 years Patient consent to participate in the study

Exclusion criteria

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 150 mEq/L) or hyponatremia (serum sodium < 130 mEq/L)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamidreza Zarei

Ahvaz University of Medical Sciences

hamidreza.zarei@yahoo.com+98 61 3222 2922

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026