Stroke Volume-based Fluid Resuscitation in AP
Purpose
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.
Condition
- Acute Pancreatitis (AP)
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- 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
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 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. |
|
Recruiting Locations
Los Angeles, California 90033
More Details
- Status
- Recruiting
- Sponsor
- University of Southern California
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.