Recruiting

Hydration Control

Sponsor:

University of Southern California

Code:

NCT07756476

Conditions

Acute Pancreatitis (AP)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Lactated Ringer's

Lactated Ringers Stroke Volume Based Dosing

Study Details

Brief summary:

The SUSTAIN Trial is a randomized control trial that allows for the control of aggressive hydration that is currently used in an inpatient setting, which can result is fluid overload in certain patients. With the impression that changes in stroke volume in individual patient will further improve the outcome.

Conditions

Acute Pancreatitis (AP)

Study ID

NCT07756476

Start date

Mar 19, 2026

Status verified date

Aug, 2026

Completion date

Sep 19, 2028

Anticipated

Primary completion date

Mar 19, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients between the age of 18-75
  • Predicted moderate and severe acute pancreatitis, which will be defined by the presence of SIRs, within 24 hours of enrollment

Exclusion Criteria:

  • Patients with the inability to preform a straight leg raise (i.e amputation)
  • Patients with high risk of adverse event related to fluid resuscitation
  • NYHA Class >= II Heart Failure
  • Child's B and C Cirrhosis
  • Dialysis Requirement
  • Clinical signs of hypervolemia, including pulmonary congestion (i.e dyspnea, pulmonary crackles on exam, interstitual edema on imaging) and ascites
  • Ages <18 years old
  • Pregnant
  • Incarcerated
  • Unable to provide informed consent

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1: Fluid Resuscitation in Stroke Volume with Leg Raise

We suggest that changes in stroke volume on individual patients can further improve outcomes with fluid resuscitation and prevent fluid overload in the individuals with acute pancreatitis.

other: Group 2: Moderate fluid resuscitation per body weight

This arm is based on a past fluid resuscitation study, WATERFALL Study, where there was moderate fluid resuscitation in the setting of treatment for acute pancreatitis.

Interventions

Lactated Ringer's

lactated ringer's in intervention is dosed based on changes in stroke volume versus a weight based strategy

Lactated Ringers Stroke Volume Based Dosing

Lactated Ringers Rate is based on changes in stroke volume

Primary outcome measure

  • SIRS Values at the 48 hours after enrollement [ Time Frame: 48 hours ]

Central Contacts and Locations

Central contacts

James L Buxbaum, MD

323 442 0876jorge.zunigagomez@med.usc.edu

Jorge Zuniga-Gomez, BS

323 442 0876jorge.zunigagomez@med.usc.edu

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Jorge Zuniga, BS

3234420876jorge.zunigagomez@med.usc.edu

Jorge ZunigaGomez, BS

3234420876jorge.zunigagomez@med.usc.edu

More Information

Sponsor

University of Southern California

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • Acute Pancreatitis
  • Fluid Resuscitation
  • Pancreatitis
  • Stroke Volume

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-08-10.