Recruiting

IV Fluids

Sponsor:

University of Calgary

Code:

NCT05211206

Conditions

ERCP

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IV fluids

Study Details

Brief summary:

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).

Conditions

ERCP

Study ID

NCT05211206

Start date

Jan 10, 2022

Status verified date

Apr, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subject referred for ERCP, regardless of indication;
  • Subject age 18 years or older;
  • Subject able to give informed consent to involvement be included.

Exclusion Criteria:

  • Subject has a standard contraindication to ERCP;
  • Subject or surrogate unable or unwilling to provide informed consent;
  • Subject age < 18 years.

Study Design

Enrollment

13000 participants

Anticipated

Interventions and Outcome Measures

Arms

Aggressive hydration

Patients with greater than or equal to 2 L of intravenous crystalloid fluids administered within the immediate pre-, peri- and post-procedural period

Conservative hydration

Patients with less than 1 L of intravenous crystalloid fluids administered within the immediate pre-, peri- and post-procedural period

Interventions

IV fluids

Amount of intravenous fluids delivered

Primary outcome measure

  • post-ERCP pancreatitis [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Nauzer Forbes, MD MSc

403-592-5089nauzer.forbes@ucalgary.ca

Locations

Peter Lougheed Hospital

Recruiting

Calgary, Alberta, Canada

Contacts

Nauzer Forbes, MD MSc

403-592-5089nauzer.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.