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

Not Applicable

• Conditions: Sepsis
• Interventions: Device: Therapeutic plasma exchange

• Registration Number: NCT03844542
• Lead Sponsor: Forsyth Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-02
• Study First Submitted: 2019-02-15
• Study First Submitted QC: 2019-02-15
• Last Update Submitted: 2019-02-15
• Study First Posted: 2019-02-18
• Last Update Posted: 2019-02-18
• Study Start: 2019-06
• Primary Completion: 2022-12
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic plasma exchange	Therapeutic plasma exchange	Perform therapeutic plasma exchange in addition to standard care for patients with sepsis induced multi-organ failure

Primary Outcome Measures

Name	Time	Method
28-Day Mortality	28 days	28 days