Acute Pancreatitis (AP)
Conditions
Keywords
Acute Pancreatitis, Fluid Resuscitation, Pancreatitis, Stroke Volume
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.
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.
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
Sponsors
University of Southern California
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SIRS Values at the 48 hours after enrollement | 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
| Measure | Time frame | Description |
|---|---|---|
| Secondary Clinical Endpoints | Beginning of randomization to 48 hours and between endpoints. | \- Participants who have a \>=2 SIRS score |
| 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. | Local complications, incidence and interventions, Organ failure, incidence and interventions (RAC definitions) |
| Dutch Composite Endpoint | Day 30 | Including death and major morbidity |
| Participant's Condition during their length of stay (LOS) | 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) |
| C Reactive protein | Randomization to 48 hours and between timepoints | Will be collected at randomization with the respective units: mg/dL |
| IL-6 | Randomization to 48 hours and between timepoints | Will be collected at randomization with the respective units: pg/dL |
| MCP-1 | Randomization to 48 hours and between timepoints | Will be collected with the respective units: pg/dL |
| Resistin | Randomization to 48 hours and between timepoints | Inflammatory Response. Will be collected with the respective units: ng/dL |
| Angiopoietin-2 | Randomization to 48 hours and between timepoints | Endothelial Function. Will be collected with the respective units: pg/dL |
| IL-8 | Randomization to 48 hours and between timepoints | Will be collected with the respective units: pg/dL |
| Lactate | Randomization to 48 hours and between timepoints | Global tissue perfusion. Will be collected with the respective units: mg/dL |
Countries
United States
Contacts
CONTACTJames L Buxbaum, MD
CONTACTJorge Zuniga-Gomez, BS
Outcome results
None listed