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Stroke Volume-based Fluid Resuscitation in AP

ConditionAcute Pancreatitis (AP)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Southern California

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lactated Ringer's

    Other intervention

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

  • Lactated Ringers Stroke Volume Based Dosing

    Other intervention

    Lactated Ringers Rate is based on changes in stroke volume

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Group 1: Fluid Resuscitation in Stroke Volume with Leg RaiseExperimental treatment 1 intervention
Group B: Group 2: Moderate fluid resuscitation per body weightOther 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southern California

Lead sponsor

Ohio State University

Collaborator

Source ClinicalTrials.gov
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