Acute Pancreatitis (AP)SUSTAINNCT07756476
Stroke Volume-based Fluid Resuscitation in AP
A study testing Lactated Ringer's and Lactated Ringers Stroke Volume Based Dosing in people with Acute Pancreatitis (AP), run by University of Southern California at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Pancreatitis (AP)
- What is being tested?
- Lactated Ringer's and Lactated Ringers Stroke Volume Based Dosing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Mar 2026to 19 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Ages <18 years old
- Pregnant
- Incarcerated
- Unable to provide informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Active, not recruiting
Ohio State University
Columbus, Ohio, 43210
- Recruiting
University of Southern California
Los Angeles, California, 90033
Jorge Zuniga, BS, 3234420876, jorge.zunigagomez@med.usc.edu
Jorge ZunigaGomez, BS, 3234420876, jorge.zunigagomez@med.usc.edu
About this study
Official title: Stroke volUme-baSed Fluid resusciTAtIoN in AP (SUSTAIN)
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.
- Conditions
- Acute Pancreatitis (AP)
- Being tested
- Lactated Ringer's, Lactated Ringers Stroke Volume Based Dosing
- Keywords
- Acute Pancreatitis, Fluid Resuscitation, Pancreatitis, Stroke Volume
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactated Ringer'sOther
lactated ringer's in intervention is dosed based on changes in stroke volume versus a weight based strategy
Lactated Ringers Stroke Volume Based DosingOther
Lactated Ringers Rate is based on changes in stroke volume
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Lactated Ringer's |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 48 hours
Secondary outcomes (12)
Secondary Clinical Endpoints
- Participants who have a >=2 SIRS score
Measured: Beginning of randomization to 48 hours and between endpoints.
Modified pancreatitis activity scoring system (mPASS) score.
Measured: From enrollment until 48 hours following enrollment.
Complications that arise during the inpatient setting
Local complications, incidence and interventions, Organ failure, incidence and interventions (RAC definitions)
Measured: From enrollment until 30 days after enrollment.
Dutch Composite Endpoint
Including death and major morbidity
Measured: Day 30
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)
Measured: From enrollment to 30 days after enrollment.
C Reactive protein
Will be collected at randomization with the respective units: mg/dL
Measured: Randomization to 48 hours and between timepoints
IL-6
Will be collected at randomization with the respective units: pg/dL
Measured: Randomization to 48 hours and between timepoints
MCP-1
Will be collected with the respective units: pg/dL
Measured: Randomization to 48 hours and between timepoints
Resistin
Inflammatory Response. Will be collected with the respective units: ng/dL
Measured: Randomization to 48 hours and between timepoints
Angiopoietin-2
Endothelial Function. Will be collected with the respective units: pg/dL
Measured: Randomization to 48 hours and between timepoints
IL-8
Will be collected with the respective units: pg/dL
Measured: Randomization to 48 hours and between timepoints
Lactate
Global tissue perfusion. Will be collected with the respective units: mg/dL
Measured: Randomization to 48 hours and between timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start19 Mar 2026
- Primary completion19 Mar 2028 (estimated)
- Study completion19 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pancreatitis (AP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * 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
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University
- Responsible party
- Principal investigator, James Buxbaum, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756476
- Sponsor's protocol ID
- HS-25-00516
- Acronym
- SUSTAIN
- Status last verified
- Aug 2026
- First submitted
- 19 Mar 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified data will be made publicly available at the conclusion of the study and following publication of the primary manuscript.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke volUme-baSed Fluid resusciTAtIoN in AP (SUSTAIN)
- ClinicalTrials.gov ID
- NCT07756476
- Acronym / sponsor ID
- SUSTAIN / HS-25-00516
- Conditions
- Acute Pancreatitis (AP)
- Keywords
- Acute Pancreatitis, Fluid Resuscitation, Pancreatitis, Stroke Volume
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Ohio State University
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 19 Mar 2028 (estimated)
- Study completion
- 19 Sep 2028 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * 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
| Arm | Type | Receives |
|---|---|---|
| Group 1: Fluid Resuscitation in Stroke Volume with Leg Raise | Experimental | Other: Lactated Ringers Stroke Volume Based DosingWe 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. |
| Group 2: Moderate fluid resuscitation per body weight | Other | Other: Lactated Ringer'sThis 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactated Ringer'slactated ringer's in intervention is dosed based on changes in stroke volume versus a weight based strategy | Other | Group 2: Moderate fluid resuscitation per body weight |
| Lactated Ringers Stroke Volume Based DosingLactated Ringers Rate is based on changes in stroke volume | Other | Group 1: Fluid Resuscitation in Stroke Volume with Leg Raise |
Primary outcome
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).
12 secondary outcomes
Secondary Clinical Endpoints
Time frame: Beginning of randomization to 48 hours and between endpoints.
Modified pancreatitis activity scoring system (mPASS) score.
Time frame: From enrollment until 48 hours following enrollment.
Complications that arise during the inpatient setting
Time frame: From enrollment until 30 days after enrollment.
Dutch Composite Endpoint
Time frame: Day 30
Participant's Condition during their length of stay (LOS)
Time frame: From enrollment to 30 days after enrollment.
C Reactive protein
Time frame: Randomization to 48 hours and between timepoints
IL-6
Time frame: Randomization to 48 hours and between timepoints
MCP-1
Time frame: Randomization to 48 hours and between timepoints
Resistin
Time frame: Randomization to 48 hours and between timepoints
Angiopoietin-2
Time frame: Randomization to 48 hours and between timepoints
IL-8
Time frame: Randomization to 48 hours and between timepoints
Lactate
Time frame: Randomization to 48 hours and between timepoints
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Undecided. De-identified data will be made publicly available at the conclusion of the study and following publication of the primary manuscript.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactated Ringer's and Lactated Ringers Stroke Volume Based Dosing in people with Acute Pancreatitis (AP), run by University of Southern California at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James L Buxbaum, MD (323 442 0876, jorge.zunigagomez@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SIRS Values at the 48 hours after enrollement (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.