Therapeutic Plasma Exchange in the Treatment of Sepsis Associated Multi-Organ Failure [SAMOF-TPE]

Forsyth Medical Center0 sites300 target enrollmentJune 2019

ConditionsSepsis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sepsis
Sponsor: Forsyth Medical Center
Enrollment: 300
Primary Endpoint: 28-Day Mortality
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The investigators prospective, randomized adult clinical trial investigates the therapeutic efficacy of early therapeutic plasma exchange as adjunct treatment to standard therapy in patients with refractory septic shock and multiple organ failure.

Registry

clinicaltrials.gov

Start Date

June 2019

End Date

June 2023

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Forsyth Medical Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult patients are eligible for inclusion if they have sepsis with refractory shock and evidence of organ failure.

Exclusion Criteria

•Persons who are pregnant
•Persons who are incarcerated
•Acute surgical catastrophe without potential for intervention or source control
•Cardiac arrest with unknown neurologic status, including patients being treated with therapeutic hypothermia
•Presence of severe acute brain injury or severe dementia
•Cardiogenic, neurogenic, obstructive, or post-cardiotomy shock
•Acute pancreatitis with no established source of infection
•Diabetic ketoacidosis as primary pathology
•Note: Septic patients who develop DKA are eligible for inclusion. However, patients in whom organ dysfunction and hemodynamic instability are due primarily to volume depletion and acidosis from DKA should not be included.
•Need for mechanical circulatory support