Therapeutic Plasma Exchange for Sepsis

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by George F Alvarez, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Alberta Health Services, Calgary

No Placebo Group

Approved in 3 Jurisdictions

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.

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.

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Peter Lougheed Centre Calgary, Canada

South Health Campus Calgary, Canada

Who Is Running the Clinical Trial?

Alberta Health Services, Calgary Lead Sponsor

References