Stroke Volume-based Fluid Resuscitation in AP

NCT07756476 | Recruiting DMC

• 1 other identifier: HS-25-00516
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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)

Keywords

Acute Pancreatitis; Fluid Resuscitation; Pancreatitis; Stroke Volume

Outcome Measures

Primary Outcomes (1)

• SIRS Values at the 48 hours after enrollement

  The primary endpoint for this study will be the presence of SIRS at 48 hours from enrollment defined as \>2 SIRS criteria (HR \>90, RR \>20, temperature \>38C or \<36C, and WBC \>12,000 or \<4,000 cells/mm3). SIRS is a marker of disease severity and also may be converted to a SIRS score (number of criterion).

  48 hours

Secondary Outcomes (12)

• Secondary Clinical Endpoints

  Beginning of randomization to 48 hours and between endpoints.

• Modified pancreatitis activity scoring system (mPASS) score.

  From enrollment until 48 hours following enrollment.

• Complications that arise during the inpatient setting

  From enrollment until 30 days after enrollment.

• Dutch Composite Endpoint

  Day 30

• Participant's Condition during their length of stay (LOS)

  From enrollment to 30 days after enrollment.

Study Arms (2)

Group 1: Fluid Resuscitation in Stroke Volume with Leg Raise

EXPERIMENTAL

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: Lactated Ringers Stroke Volume Based Dosing

Group 2: Moderate fluid resuscitation per body weight

OTHER

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.

Other: Lactated Ringer's

Interventions

Lactated Ringer's OTHER

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

Group 2: Moderate fluid resuscitation per body weight

Lactated Ringers Stroke Volume Based Dosing OTHER

Lactated Ringers Rate is based on changes in stroke volume

Group 1: Fluid Resuscitation in Stroke Volume with Leg Raise

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• Ohio State University: collaborator

Study Sites (2)

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Pancreatitis

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

James L Buxbaum, MD

CONTACT

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

Jorge Zuniga-Gomez, BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Scholar, MD

Model Details: * Group 1: Resuscitation based on the change in stroke volume in response to passive leg raising test * Group 2: Moderate resuscitation based on body weight, as per WATERFALL trial

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: August 10, 2026
• Study Start: March 19, 2026
• Primary Completion (Estimated): March 19, 2028
• Study Completion (Estimated): September 19, 2028
• Last Updated: August 10, 2026

Record last verified: 2026-08

Locations

US (2)