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

NCT03844542 | Unknown FDA Device

• 1 other identifier: 18-1187
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• 28-Day Mortality

  28 days

  28 days

Study Arms (2)

Therapeutic plasma exchange

EXPERIMENTAL

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

Device: Therapeutic plasma exchange

Standard care alone for sepsis

NO INTERVENTION

Standard care for patients with sepsis induced multi-organ failure

Interventions

Therapeutic plasma exchange DEVICE

Perform therapeutic plasma exchange in patients with sepsis induced multi-organ failure

Therapeutic plasma exchange

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Forsyth Medical Center: lead

MeSH Terms

Conditions

Sepsis

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Central Study Contacts

Philip Keith, MD

CONTACT

843.693.0412; pkeith@salemchest.com

Jeremy Hodges, RPh

CONTACT

336.718.8729; jlhodges@novanthealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 18, 2019
• Study Start: June 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: February 18, 2019

Record last verified: 2019-02