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NCT Number: NCT07756476

Stroke Volume-based Fluid Resuscitation in AP

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.

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Key information

Conditions

Acute Pancreatitis (AP) Digestive System Diseases Pancreatic Diseases Pancreatitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California, Los Angeles, California, United States

Loading trial locations.

About this study

The proposed SUSTAIN Trial Study (Stroke volUme-baSed fluid resuscitation), a multi-center randomized controlled trial which will address these knowledge gaps in acute pancreatitis. Recently demonstration from the WATERFALL (Early Weight-Based Aggressive vs. ModeraTE Goal-DiRected Fluid ResuscitAtion) randomized controlled trial that aggressive hydration increased the risk of fluid overload without improving the clinical course of AP compared with a moderate hydration strategy. With further suggestions, rather than a generic body weight-based approach, tailoring fluid requirements to changes in stoke volume in individual patients will further improve outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactated Ringer's

Other

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

Lactated Ringers Stroke Volume Based Dosing

Other

Lactated Ringers Rate is based on changes in stroke volume

Primary outcomes

  1. SIRS Values at the 48 hours after enrollement

    Time frame: 48 hours

    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).

Secondary outcomes

  1. Secondary Clinical Endpoints

    Time frame: Beginning of randomization to 48 hours and between endpoints.

    • Participants who have a >=2 SIRS score

  2. Modified pancreatitis activity scoring system (mPASS) score.

    Time frame: From enrollment until 48 hours following enrollment.

  3. Complications that arise during the inpatient setting

    Time frame: From enrollment until 30 days after enrollment.

    Local complications, incidence and interventions, Organ failure, incidence and interventions (RAC definitions)

  4. Dutch Composite Endpoint

    Time frame: Day 30

    Including death and major morbidity

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

    Time frame: From enrollment to 30 days after enrollment.

    The amount of days alive and wellbeing of the participant, including length of stay (LOS) and days in/out of the Intensive Care Unit (ICU)

  6. C Reactive protein

    Time frame: Randomization to 48 hours and between timepoints

    Will be collected at randomization with the respective units: mg/dL

  7. IL-6

    Time frame: Randomization to 48 hours and between timepoints

    Will be collected at randomization with the respective units: pg/dL

  8. MCP-1

    Time frame: Randomization to 48 hours and between timepoints

    Will be collected with the respective units: pg/dL

  9. Resistin

    Time frame: Randomization to 48 hours and between timepoints

    Inflammatory Response. Will be collected with the respective units: ng/dL

  10. Angiopoietin-2

    Time frame: Randomization to 48 hours and between timepoints

    Endothelial Function. Will be collected with the respective units: pg/dL

  11. IL-8

    Time frame: Randomization to 48 hours and between timepoints

    Will be collected with the respective units: pg/dL

  12. Lactate

    Time frame: Randomization to 48 hours and between timepoints

    Global tissue perfusion. Will be collected with the respective units: mg/dL

Study contacts

Contact information is provided by the study sponsor or research team.

James L Buxbaum, MD

CONTACT

[email protected]

323 442 0876

Jorge Zuniga-Gomez, BS

CONTACT

[email protected]

323 442 0876

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Ohio State University

Registry information

Official study title

Stroke volUme-baSed Fluid resusciTAtIoN in AP (SUSTAIN)

Acronym: SUSTAIN

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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