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Plasma Exchange

Treatment Arm for Septic Shock (PLEXSIS Trial)

Phase 2

Recruiting

Led By Ryan Zarychanski, MD, MSc

Research Sponsored by University of Manitoba

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

PLEXSIS Trial Summary

"This trial will compare therapeutic plasma exchange to standard treatment in patients with septic shock at multiple hospitals to see if it is feasible."

Who is the study for?

This trial is for adults over 18 with septic shock, who have low blood pressure despite high-dose vasopressors and fluids, kidney injury as per KDIGO guidelines, need mechanical breathing support or have a low P/F ratio, significant drop in platelets, or severe acidosis with high lactate levels.Check my eligibility

What is being tested?

The study tests if therapeutic plasma exchange can help patients with septic shock compared to standard treatments. Participants are randomly chosen to receive either the plasma exchange procedure or continue with their usual care without it.See study design

What are the potential side effects?

Potential side effects of therapeutic plasma exchange may include allergic reactions, bleeding due to anticoagulants used during the procedure, infection at catheter insertion site, and changes in blood pressure.

PLEXSIS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assess the feasibility of a large, multicenter trial of TPE in patients with septic shock

Secondary outcome measures

Assess the rate of enrollment and adherence to the protocol of those enrolled

Further understand the biological impact of TPE in sepsis

Number of participants that develop adverse reactions to TPE

Other outcome measures

Mortality

Organ failure

Side effects data

From 2020 Phase 2 trial • 20 Patients • NCT04374149

10%

myocardial infarction

100%

80%

60%

40%

20%

Study treatment Arm

1 - TPE Alone

2 - TPE Plus Ruxolitinib

PLEXSIS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment ArmExperimental Treatment1 Intervention

Participants randomized to the Treatment Arm will received 1.0 plasma exchanges daily until discontinuation of vasopressors, death or to a maximum of 5 daily treatments. Solvent detergent plasma (SDP) or frozen plasma (FP) depending on availability will be used as the replacement fluid.

Group II: Standard of Care ArmActive Control1 Intervention

Participants randomized to the Control Arm will receive standard of care for the treatment of septic shock in accordance with local practice and informed by national and international guidelines.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of TorontoOTHER

690 Previous Clinical Trials

1,019,563 Total Patients Enrolled

Health Sciences Centre Foundation, ManitobaOTHER

14 Previous Clinical Trials

8,657 Total Patients Enrolled

McMaster UniversityOTHER

886 Previous Clinical Trials

2,598,388 Total Patients Enrolled

3 Trials studying Septic Shock

509 Patients Enrolled for Septic Shock

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the treatment arm received official authorization from the FDA?

"Based on our evaluation at Power, the safety level of the Treatment Arm is rated as 2. This assessment aligns with it being a Phase 2 trial where there is limited data supporting its safety but no evidence yet regarding efficacy."

Answered by AI

Are patients currently being accepted to participate in this clinical trial?

"As indicated on clinicaltrials.gov, this research endeavor is actively seeking eligible participants. The trial's initial posting was dated June 1st, 2023, with the most recent update occurring on April 3rd, 2024."

Answered by AI

In how many different geographical areas can patients access this clinical trial?

"The ongoing clinical trial is operational at a total of 7 sites, including cities like Winnipeg, Hamilton, and Ottawa. Opting for the nearest location when participating can help reduce travel-related inconveniences."

Answered by AI

What is the total number of individuals actively engaged in this medical study?

"Yes, according to the information available on clinicaltrials.gov, this investigation is currently seeking volunteers. The initial posting date for this study was 6/1/2023, with the most recent update occurring on 4/3/2024. Enrollment of 80 participants is sought across seven distinct sites."

Answered by AI

Recent research and studies

Intensive Care MedicineJournal

Plasmapheresis in Severe Sepsis and Septic Shock: A Prospective, Randomised, Controlled Trial

Busund, Rolf, Vladimir Koukline, Uri Utrobin, and Edvard Nedashkovsky. 2002. “Plasmapheresis in Severe Sepsis and Septic Shock: A Prospective, Randomised, Controlled Trial”. Intensive Care Medicine. Springer Science and Business Media LLC. doi:10.1007/s00134-002-1410-7.

Critical Care MedicineJournal

Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock: 2008

Dellinger, R Phillip, Mitchell M. Levy, Jean M. Carlet, Julian Bion, Margaret M. Parker, Roman Jaeschke, Konrad Reinhart, et al.. 2008. “Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock: 2008”. Critical Care Medicine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.ccm.0000298158.12101.41.

clinicaltrials.govStudy

Therapeutic Plasma Exchange in Septic Shock: A Pilot Study

2023. "Therapeutic Plasma Exchange in Septic Shock: A Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05093075.