Therapeutic Plasma Exchange in Septic Shock: A Pilot Study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Septic Shock
- Sponsor
- University of Manitoba
- Enrollment
- 80
- Locations
- 11
- Primary Endpoint
- Assess the feasibility of a large, multicenter trial of TPE in patients with septic shock
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief 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.
Detailed 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Assess the feasibility of a large, multicenter trial of TPE in patients with septic shock
Time Frame: 18 months for enrollment
Assessing the feasibility of a large, multicenter trial of TPE in patients with septic shock will be the primary outcome. The primary measure of feasibility will be the ability to enroll an average of 2 patients per site per month.
Secondary Outcomes
- Assess the rate of enrollment and adherence to the protocol of those enrolled(18 months)
- Further understand the biological impact of TPE in sepsis(up to 8 days)
- Number of participants that develop adverse reactions to TPE(Up to 8 days)