Recruiting

Intravenous Fluids

Sponsor:

University of Calgary

Code:

NCT06260878

Conditions

Post-ERCP Acute Pancreatitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Intravenous Ringer's lactate

Study Details

Brief summary:

This study will explore the efficacies of several practical short-term (peri-procedural) intravenous fluid regimens in the prevention of post- endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). PEP is the most common serious ERCP-related adverse event (AE), occurring in 5-15% of patients, and associated with significant morbidity, mortality, and healthcare utilization. Given the current lack of data on effectiveness of short-term fluid regimens in PEP prevention to inform practice, the results of the proposed study have the strong potential to impact ERCP practices worldwide, whether positive or negative.

Conditions

Post-ERCP Acute Pancreatitis

Study ID

NCT06260878

Start date

Nov 22, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. age 18-75 years (due to higher likelihood of undiagnosed cardiac disease or renal insufficiency in patients >75 years of age)
2. ability to give informed consent
3. native major papillary anatomy
4. ability and willingness to obtain bloodwork the day after ERCP

Exclusion Criteria:

1. prior ERCP with sphincterotomy and/or sphincteroplasty
2. confirmed or suspected cholangitis or sepsis
3. confirmed pancreatitis, hyperlipasemia, or hyperamylasemia within the preceding 7 days
4. NYHA Class II or greater heart failure
5. active pulmonary edema
6. myocardial infarction or ischemia within the preceding 3 months
7. renal insufficiency with CrCl < 40 mL/minute
8. CPT Class B or C cirrhosis and/or end-stage liver disease
9. room air oxygen saturation <90% or requirement of home O2
10. hypernatremia with Na+ ≥ 150 mEq/L or Na+ <130 mEq/L
11. uncontrolled hypertension or hypotension
12. pregnant status

Study Design

Enrollment

505 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Ringer's lactate 2500 cc IV

experimental: Ringer's lactate 2000 cc IV

experimental: Ringer's lactate 1500 cc IV

experimental: Ringer's lactate 1000 cc IV

active comparator: Ringer's lactate 500 cc IV

Interventions

Intravenous Ringer's lactate

Intravenous Ringer's lactate

Primary outcome measure

  • Serum amylase [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Nauzer Forbes, MD, MSc

403-880-8508nauzer.forbes@ucalgary.ca

Locations

Peter Lougheed Centre

Recruiting

Calgary, Alberta, Canada, T1Y 6J4

Contacts

Nauzer Forbes, MD

403-880-8508nauzer.forbes@ucalgary.ca

More Information

Sponsor

University of Calgary

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2026-04-29.