Therapeutic Plasma Exchange in Septic Shock: A Pilot Study

Status Recruiting

Clinical Trial Summary

The investigators propose to conduct a multi-center randomized pilot feasibility trial comparing therapeutic plasma exchange to standard of care in patients diagnosed with septic shock.

Clinical Trial Description

The intervention arm consists of an exchange of one volume of plasma equivalent to the patient's total calculated blood volume (1.0 plasma volume exchange) performed daily until discontinuation of vasopressors, death or up to a maximum of 5 daily treatments. Solvent detergent plasma or frozen plasma (FP) depending on availability will be used as the replacement fluid. The control group will receive standard of care for the treatment of septic shock in accordance with local practice and informed by national and international guidelines. The management of septic shock, including but not limited to, antibiotic therapy, infection source control, therapy, fluid therapy, mechanical ventilation, and nutrition, will be at the discretion of the treating medical team, and will be recorded and reported. The investigators will monitor for development of coagulopathy by measure the INR and fibrinogen levels daily. These are expected to normalize with the use of plasma as replacement fluid. The investigators will monitor for adverse reactions related to central venous access devices (insertion related complications, infection, thrombosis) and/or TPE (including reaction to plasma, allergic reactions and hypotension). Venous access devices will be inserted by trained, experienced personnel using real-time ultrasound guidance. These data are routinely collected by apheresis programs across Canada as part of a data collection and reporting relationship with CAG. To further our understanding of the biologic impact of TPE in sepsis, plasma and whole blood samples will be collected at randomization (day 1), Pre-3rd TPE or Day 3 if in SOC group, pre-5th TPE or Day if SOC group, and 48 hours after completion of TPE or Day 7 if SOC group to evaluate markers of coagulation (ADAMTS-13 levels, DNase levels, histones). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05093075
Study type	Interventional
Source	University of Manitoba
Contact	Emily Rimmer, MD, MSc
Phone	204-787-2128
Email	erimmer@cancercare.mb.ca
Status	Recruiting
Phase	Phase 2
Start date	June 1, 2023
Completion date	December 2026

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See also
Status	Clinical Trial	Phase
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Completed	`NCT04227652` - Control of Fever in Septic Patients	N/A
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Recruiting	`NCT02676427` - Fluid Responsiveness in Septic Shock Evaluated by Caval Ultrasound Doppler Examination
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Not yet recruiting	`NCT02547467` - TOADS Study: TO Assess Death From Septic Shock.	N/A
Terminated	`NCT02335723` - ASSET - a Double-Blind, Randomized Placebo-Controlled Clinical Investigation With Alteco® LPS Adsorber	N/A
Completed	`NCT02638545` - Hemodynamic Effects of Dexmedetomidine in Septic Shock	Phase 3
Completed	`NCT02204852` - Co-administration of Iloprost and Eptifibatide in Septic Shock Patients	Phase 2
Completed	`NCT02079402` - Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Therapeutic Plasma Exchange in Septic Shock: A Pilot Study — PLEXSIS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms