Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

• age 18-75 years (due to higher likelihood of undiagnosed cardiac disease or renal insufficiency in patients \>75 years of age)

• ability to give informed consent

• native major papillary anatomy

• ability and willingness to obtain bloodwork the day after ERCP

Locations
Other Locations
Canada
Peter Lougheed Centre
RECRUITING
Calgary
Contact Information
Primary
Nauzer Forbes, MD, MSc
nauzer.forbes@ucalgary.ca
403-880-8508
Time Frame
Start Date: 2024-11-22
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 505
Treatments
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
Sponsors
Leads: University of Calgary

This content was sourced from clinicaltrials.gov