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

February 15, 2019 updated by: Forsyth Medical Center
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

  • Prolonged acute illness with > 24 hours of pressor needs at enrollment and/or end organ damage with further care deemed to be "futile."

    • NOTE: The time resets if a new inciting event leads to SAMOF.
    • For example, if a patient has sepsis stabilized but requires operative intervention for source control within the initial 24 hours of admission and returns to the ICU with SAMOF, the patient is again eligible for randomization for the next 24 hours.
  • Bedbound state or poor baseline functional status with ECOG performance status score ≥ 3
  • Underlying terminal illness/malignancy with < 6 months life expectancy
  • Advanced chronic liver disease/cirrhosis with evidence of portal hypertension
  • Asplenia
  • HIV with HARRT non-compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Therapeutic plasma exchange
Perform therapeutic plasma exchange in addition to standard care for patients with sepsis induced multi-organ failure
Device: Therapeutic plasma exchange
Perform therapeutic plasma exchange in patients with sepsis induced multi-organ failure
NO_INTERVENTION: Standard care alone for sepsis
Standard care for patients with sepsis induced multi-organ failure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28-Day Mortality
Time Frame: 28 days
28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forsyth Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2019

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

June 1, 2023

Study Registration Dates

First Submitted

February 15, 2019

First Submitted That Met QC Criteria

February 15, 2019

First Posted (ACTUAL)

February 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 18, 2019

Last Update Submitted That Met QC Criteria

February 15, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-1187

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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