ClinicalTrials.gg
RecruitingNCT07756476SUSTAINUpdated Aug 10, 2026

Stroke Volume-based Fluid Resuscitation in AP

An interventional study of Lactated Ringer's and Lactated Ringers Stroke Volume Based Dosing in Acute Pancreatitis (AP), sponsored by University of Southern California. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by University of Southern California · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Acute Pancreatitis (AP)

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Keywords

  • Acute Pancreatitis
  • Fluid Resuscitation
  • Pancreatitis
  • Stroke Volume
03

In context

Pancreatitis

557 studies on the registry are indexed under Pancreatitis; 164 are open to participants now.

This study's planned enrollment of 80 is below the median of 100 across 349 interventional studies indexed under Pancreatitis.

Browse Pancreatitis studies →

Lead sponsor

University of Southern California is the lead sponsor of 791 studies on the registry; 136 are open to participants now.

Of its 70 completed or terminated interventional studies of FDA-regulated products, 32 (46%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study 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: Lactated Ringers Stroke Volume Based Dosing

  • 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.

    Other: Lactated Ringer's

Interventions

  • OtherLactated Ringer's

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

  • OtherLactated Ringers Stroke Volume Based Dosing

    Lactated Ringers Rate is based on changes in stroke volume

06

What researchers measure

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).

    Time frame: 48 hours

Secondary outcomes

  1. Secondary Clinical Endpoints

    \- Participants who have a \>=2 SIRS score

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

  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

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

    Time frame: From enrollment until 30 days after enrollment.

  4. Dutch Composite Endpoint

    Including death and major morbidity

    Time frame: Day 30

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

    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)

    Time frame: From enrollment to 30 days after enrollment.

  6. C Reactive protein

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

    Time frame: Randomization to 48 hours and between timepoints

  7. IL-6

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

    Time frame: Randomization to 48 hours and between timepoints

  8. MCP-1

    Will be collected with the respective units: pg/dL

    Time frame: Randomization to 48 hours and between timepoints

  9. Resistin

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

    Time frame: Randomization to 48 hours and between timepoints

  10. Angiopoietin-2

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

    Time frame: Randomization to 48 hours and between timepoints

  11. IL-8

    Will be collected with the respective units: pg/dL

    Time frame: Randomization to 48 hours and between timepoints

  12. Lactate

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

    Time frame: Randomization to 48 hours and between timepoints

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — De-identified data will be made publicly available at the conclusion of the study and following publication of the primary manuscript.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Mar 2028, 24 months after the start.

Of 91 non-industry interventional studies with no phase under Pancreatitis, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 59. This study's planned 24 months is below that.

Counting every sponsor, half of 94 studies reached it within 32 months; a quarter within 23 and three quarters within 59.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2026
First posted
Aug 10, 2026
StartActual
Mar 19, 2026
Primary completionEst.
Mar 19, 2028
CompletionEst.
Sep 19, 2028
Last update
Aug 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07756476
Responsible party
James Buxbaum (Principal Investigator, Clinical Scholar, MD, University of Southern California) — Principal investigator
First posted
Aug 10, 2026
Start date
Mar 19, 2026
Primary completion
Mar 19, 2028 (estimated)
Completion
Sep 19, 2028 (estimated)
Last update
Aug 10, 2026

Study contacts

James L Buxbaum, MD
Contact
jorge.zunigagomez@med.usc.edu
323 442 0876
Jorge Zuniga-Gomez, BS
Contact
jorge.zunigagomez@med.usc.edu
323 442 0876

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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