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

Last updated: December 17, 2024
Sponsor: University of Calgary
Overall Status: Active - Recruiting

Phase

4

Condition

Pancreatitis

Treatment

Intravenous Ringer's lactate

Clinical Study ID

NCT06260878
REB23-0625
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. age 18-75 years (due to higher likelihood of undiagnosed cardiac disease or renalinsufficiency 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

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 7days

  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

Total Participants: 505
Treatment Group(s): 1
Primary Treatment: Intravenous Ringer's lactate
Phase: 4
Study Start date:
November 22, 2024
Estimated Completion Date:
June 30, 2028

Connect with a study center

  • Peter Lougheed Centre

    Calgary, Alberta T1Y 6J4
    Canada

    Active - Recruiting

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