IV Fluids and Post-ERCP Pancreatitis
ConditionERCP
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Calgary
About this trial
Aggressive intravenous hydration has been shown in randomized trials to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP), though studied regimens are often impractical. To date, no studies have prospectively assessed short-term (60-90 minute) aggressive hydration regimens that are feasible for outpatients undergoing ERCP and subsequent discharge. Furthermore, little is known with regard to fluid type, volume, and timing with respect to ERCP. In this study, we will aim to assess whether the amount of peri-procedural intravenous fluid administered around the time of ERCP is associated with the risk of PEP (the primary outcome).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject referred for ERCP, regardless of indication;
Subject age 18 years or older;
Subject able to give informed consent to involvement be included.
Disqualifiers
Subject has a standard contraindication to ERCP;
Subject or surrogate unable or unwilling to provide informed consent;
Subject age < 18 years.
Trial population
Patients referred to a hospital-based endoscopy unit for consideration of ERCP.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
IV fluids
Other interventionAmount of intravenous fluids delivered
Treatment groups
13,000 Participants
are divided into 2 treatment groupsGroup A: Aggressive hydration1 intervention
Group B: Conservative hydration1 intervention
Trial outcomes
Primary outcomes
1
post-ERCP pancreatitis
Number of participants with any 2 of: (1) epigastric abdominal pain, (2) serum amylase/lipase \>3x the upper limit of normal, (3) imaging findings consistent with acute pancreatitis
Time frame
30 daysSponsors and contacts
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University of Calgary
Lead sponsor
McGill University
Collaborator
University of Ottawa
Collaborator
Queen's University
Collaborator
Halton Health (Oakville)
Collaborator
Island Health, Victoria, BC
Collaborator
Source ClinicalTrials.gov