Therapeutic Plasma Exchange in Adult Patients With Severe Sepsis

NCT04057872 | Completed Phase 1

• 1 other identifier: REB19-1157
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief Summary

The incidence of sepsis (severe infection) has increased over the last four decades. Severe sepsis and septic shock are among the leading causes of death for patients admitted to critical care units with mortality ranging from 20-70% depending on totality of organ dysfunction. Outside of antibiotics and good bedside care, little has changed in the management of this life-threatening problem. Therapeutic plasma exchange (TPE) involves the separation of plasma from whole blood. The removed plasma is 'exchanged or replaced' with either IV fluids, albumin, blood products or a combination thereof. The primary objective of this study is to evaluate the safety of the TPE intervention protocol within 24 hours of study criteria being met. TPE is now a well-established program at the South Health Campus for neuro-muscular disorders. Since starting in May 2018, the investigators have performed over 150 runs making the SHC ICU one of the most experienced centers in Canada.

Conditions

Septic Shock

Keywords

Therapeutic Plasma Exchange (TPE); Septic Shock; Severe Sepsis; Albumin; Fresh Frozen Plasma

Outcome Measures

Primary Outcomes (4)

• Adverse Events

  Proportion of patients who experience at least 1 Adverse Event (AE)

  During course of ICU stay, could be up to 6 months

• Discontinue TPE

  Proportion of patients who discontinue TPE administration due to an AE

  During course of ICU stay, could be up to 6 months

• Enrollment Rate

  3\. Enrollment rate (patients screened, patients eligible, patients approached, patients enrolled)

  During course of ICU stay, could be up to 6 months

• Protocol Completion

  Protocol completion (patients who complete study protocol)

  During course of ICU stay, could be up to 6 months

Secondary Outcomes (6)

• Organ dysfunction

  During course of ICU stay, could be up to 6 months

• Vasopressor support

  During course of ICU stay, could be up to 6 months

• Ventilator support

  During course of ICU stay, could be up to 6 months

• Days in ICU

  During course of ICU stay, could be up to 6 months

• Mortality

  During course of ICU stay, could be up to 6 months

Study Arms (1)

TPE in Septic Shock

EXPERIMENTAL

The patients will undergo a dosing trial to determine safety and the most effective dose

Procedure: Therapeutic plasma exchange

Interventions

Therapeutic plasma exchange PROCEDURE

The removed plasma is 'exchanged or replaced' with either IV fluids, albumin, and/or Fresh frozen plasma

TPE in Septic Shock

Eligibility Criteria

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

You may qualify if:

• Exhibiting two of the four clinical signs of inflammation:
• Core temperature \> 38oC or \< 36oC
• Heart rate \> 90 beats per minute
• Respiratory rate \> 20 breaths per minute, or PaCO2 \< 32 mmHg, or mechanical ventilation
• White cell count \> 12 x 109/L or \< 4 x 109/L or \> 10% immature neutrophils
• We will further identify the subset with a hospital mortality in excess of 40%:
• \>30 mls/kg fluid resuscitation
• Noradrenaline \>0.1 ug/kg/min to maintain MAP\> 65mmHg for at least 4 consecutive hours and present at initiation of TPE
• Lactate \>2 mmol/l.

Sponsors & Collaborators

• Alberta Health Services, Calgary: lead

Study Sites (2)

Peter Lougheed Centre

Calgary, Alberta, T3M 1M4, Canada

Location

South Health Campus

Calgary, Alberta, T3M 1M4, Canada

Location

Related Publications (30)

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MeSH Terms

Conditions

Shock, Septic; Sepsis

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• George F Alvarez, MD

  Alberta Health services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Intensivist, Department of Critical Care Medicine

Model Details: Consecutive Adults patients with vasoplegic septic shock with at least 2 organ dysfunction will receive TPE

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 15, 2019
• Study Start: October 21, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data will be made available once published. It will be made available for 5 years as per University of Calgary data storage protocol.

Locations

CA (2)