Therapeutic Plasma Exchange for Sepsis

Recruiting at 1 trial location

Overseen By Miranda Kavalench

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Alberta Health Services, Calgary

Disqualifiers: Imminent death, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

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

17 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a treatment called Therapeutic Plasma Exchange (TPE) for critically ill adults with septic shock. TPE involves removing harmful substances from the blood and replacing them with clean fluids. The goal is to see if this treatment is safe and can help reduce the severe effects of infection. TPE has shown potential benefits in improving survival.

Research Team

George F Alvarez, MD

Principal Investigator

Alberta Health services

Eligibility Criteria

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

I need medication to keep my blood pressure above 65 mmHg.

Core temperature > 38oC or < 36oC

Lactate >2 mmol/l.

Exclusion Criteria

Patients will be excluded in cases where death is deemed inevitable or imminent during admission and either the attending physician, patient or surrogate legal decision maker is not committed to active treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

24 hours

Treatment

Participants undergo therapeutic plasma exchange (TPE) to evaluate safety and determine the most effective dose

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

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and organ dysfunction

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

Treatment Details

Interventions

• Therapeutic Plasma Exchange

Trial Overview The trial is testing the safety of Therapeutic Plasma Exchange (TPE) within 24 hours for patients with severe sepsis. TPE removes plasma from blood and replaces it with other fluids or products. The study leverages experience from a Canadian ICU experienced in TPE for neuro-muscular disorders.

Participant Groups

Group I: TPE in Septic Shock Experimental Treatment 1 Intervention

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

Therapeutic Plasma Exchange is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Therapeutic Plasma Exchange for:

• Thrombotic thrombocytopenic purpura
• Guillain-Barré syndrome
• Multiple sclerosis
• Chronic inflammatory demyelinating polyradiculoneuropathy
• Lambert-Eaton syndrome
• Myasthenia gravis
• Goodpasture syndrome

Approved in United States as Therapeutic Plasma Exchange for:

• Thrombotic thrombocytopenic purpura
• Guillain-Barré syndrome
• Multiple sclerosis
• Chronic inflammatory demyelinating polyradiculoneuropathy
• Lambert-Eaton syndrome
• Myasthenia gravis
• Goodpasture syndrome
• Sepsis with multiorgan failure

Approved in Canada as Therapeutic Plasma Exchange for:

• Thrombotic thrombocytopenic purpura
• Guillain-Barré syndrome
• Multiple sclerosis
• Chronic inflammatory demyelinating polyradiculoneuropathy
• Lambert-Eaton syndrome
• Myasthenia gravis
• Goodpasture syndrome

Who Is Running the Clinical Trial?

Alberta Health Services, Calgary

Lead Sponsor

Trials

15

Recruited

2,600+