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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
lactated ringer's in intervention is dosed based on changes in stroke volume versus a weight based strategy
Lactated Ringers Rate is based on changes in stroke volume
University of Southern California
Los Angeles, California, United States
RECRUITINGOhio State University
Columbus, Ohio, United States
ACTIVE_NOT_RECRUITINGSIRS 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 Clinical Endpoints
\- Participants who have a \>=2 SIRS score
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
Local complications, incidence and interventions, Organ failure, incidence and interventions (RAC definitions)
Time frame: From enrollment until 30 days after enrollment.
Dutch Composite Endpoint
Including death and major morbidity
Time frame: 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)
Time frame: From enrollment to 30 days after enrollment.
C Reactive protein
Will be collected at randomization with the respective units: mg/dL
Time frame: Randomization to 48 hours and between timepoints
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IL-6
Will be collected at randomization with the respective units: pg/dL
Time frame: Randomization to 48 hours and between timepoints
MCP-1
Will be collected with the respective units: pg/dL
Time frame: Randomization to 48 hours and between timepoints
Resistin
Inflammatory Response. Will be collected with the respective units: ng/dL
Time frame: Randomization to 48 hours and between timepoints
Angiopoietin-2
Endothelial Function. Will be collected with the respective units: pg/dL
Time frame: Randomization to 48 hours and between timepoints
IL-8
Will be collected with the respective units: pg/dL
Time frame: Randomization to 48 hours and between timepoints
Lactate
Global tissue perfusion. Will be collected with the respective units: mg/dL
Time frame: Randomization to 48 hours and between timepoints