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

NCT ID: NCT06260878

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

505 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-22

Study Completion Date

2028-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Post-ERCP Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ringer's lactate 2500 cc IV

Group Type EXPERIMENTAL

Intravenous Ringer's lactate

Intervention Type OTHER

Intravenous Ringer's lactate

Ringer's lactate 2000 cc IV

Group Type EXPERIMENTAL

Intravenous Ringer's lactate

Intervention Type OTHER

Intravenous Ringer's lactate

Ringer's lactate 1500 cc IV

Group Type EXPERIMENTAL

Intravenous Ringer's lactate

Intervention Type OTHER

Intravenous Ringer's lactate

Ringer's lactate 1000 cc IV

Group Type EXPERIMENTAL

Intravenous Ringer's lactate

Intervention Type OTHER

Intravenous Ringer's lactate

Ringer's lactate 500 cc IV

Group Type ACTIVE_COMPARATOR

Intravenous Ringer's lactate

Intervention Type OTHER

Intravenous Ringer's lactate

Interventions

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Intravenous Ringer's lactate

Intravenous Ringer's lactate

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peter Lougheed Centre

Calgary, Alberta, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Nauzer Forbes, MD, MSc

Role: CONTACT

Phone: 403-880-8508

Email: [email protected]

Facility Contacts

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Nauzer Forbes, MD

Role: primary

Other Identifiers

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REB23-0625

Identifier Type: -

Identifier Source: org_study_id