Therapeutic Plasma Exchange for Sepsis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a procedure called Therapeutic Plasma Exchange (TPE) to determine its safety for people with septic shock, a severe and life-threatening condition caused by a serious infection. TPE involves removing the liquid part of the blood (plasma) and replacing it with a substitute like IV fluids. The trial targets patients with confirmed or highly suspected septic shock who exhibit specific signs such as high or low body temperature, rapid heart rate, or difficulty breathing. Participants must have a high risk of mortality and require significant medical support, including fluid resuscitation and medication to maintain blood pressure. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this therapeutic plasma exchange protocol is safe for treating sepsis?
Research has shown that therapeutic plasma exchange (TPE) is generally well-tolerated. One study found that TPE did not clearly improve organ failure or death rates in patients with sepsis. However, some reports suggest that TPE might improve survival compared to standard treatments. Specifically, some studies have found a 20.5% reduction in death rates within 28 days for septic patients who received TPE.
TPE is already used for other conditions, such as nerve and muscle disorders, indicating it is considered relatively safe. Since 2018, over 150 TPE procedures have been performed at a Canadian health center without major safety issues.
While the current study is still in its early stages, the existing use of TPE for other conditions and data from previous studies suggest that it could be safe for treating septic shock.12345Why are researchers excited about this trial?
Unlike the standard treatments for sepsis, which often involve antibiotics and supportive care like fluids and vasopressors, Therapeutic Plasma Exchange (TPE) offers a unique approach. TPE works by filtering out harmful substances, such as toxins and inflammatory mediators, from the blood, which could potentially lessen the severity of septic shock. Researchers are excited because this method directly targets the underlying drivers of inflammation in sepsis, potentially leading to faster and more effective recovery. This novel approach might provide a critical advantage in managing a condition that has traditionally been difficult to treat with existing therapies.
What evidence suggests that therapeutic plasma exchange might be an effective treatment for sepsis?
Research suggests that therapeutic plasma exchange (TPE), which participants in this trial will receive, might help patients with septic shock. Studies have found that TPE can improve blood clotting and increase platelet levels, potentially lowering the risk of bleeding. Reviews of multiple studies indicate that TPE could enhance survival when used alongside standard treatments for serious conditions like septic shock. Some research highlights that TPE may reduce harmful proteins and inflammation in the blood. While these findings are encouraging, most of the evidence remains preliminary, and further research is needed to confirm these benefits.23456
Who Is on the Research Team?
George F Alvarez, MD
Principal Investigator
Alberta Health services
Are You a Good Fit for This Trial?
Adults over 18 with severe sepsis or septic shock, showing signs of inflammation and infection. They must have a high risk of hospital mortality, need significant fluid resuscitation and drugs to maintain blood pressure, and may require mechanical ventilation. Those not committed to active treatment or near death are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo therapeutic plasma exchange (TPE) to evaluate safety and determine the most effective dose
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events and organ dysfunction
What Are the Treatments Tested in This Trial?
Interventions
- Therapeutic Plasma Exchange
Therapeutic Plasma Exchange is already approved in European Union, United States, Canada for the following indications:
- Thrombotic thrombocytopenic purpura
- Guillain-Barré syndrome
- Multiple sclerosis
- Chronic inflammatory demyelinating polyradiculoneuropathy
- Lambert-Eaton syndrome
- Myasthenia gravis
- Goodpasture syndrome
- Thrombotic thrombocytopenic purpura
- Guillain-Barré syndrome
- Multiple sclerosis
- Chronic inflammatory demyelinating polyradiculoneuropathy
- Lambert-Eaton syndrome
- Myasthenia gravis
- Goodpasture syndrome
- Sepsis with multiorgan failure
- Thrombotic thrombocytopenic purpura
- Guillain-Barré syndrome
- Multiple sclerosis
- Chronic inflammatory demyelinating polyradiculoneuropathy
- Lambert-Eaton syndrome
- Myasthenia gravis
- Goodpasture syndrome
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alberta Health Services, Calgary
Lead Sponsor