What side effects are associated with this type of intervention?

Therapeutic Plasma Exchange (TPE) for septic shock can cause side effects such as hypotension, allergic reactions, infections, and bleeding due to the removal of clotting factors. Other potential complications include electrolyte imbalances and catheter-related issues. Common treatments for septic shock, such as antibiotics and aggressive IV fluid administration, can also lead to side effects like antibiotic resistance, kidney injury, and fluid overload.

What prior FDA approvals exist?

The FDA has not approved specific treatments for septic shock that directly align with the mechanism of Therapeutic Plasma Exchange (TPE). TPE, which involves the separation and replacement of plasma to remove harmful substances, is primarily used in other conditions such as neuro-muscular disorders. For septic shock, the mainstay treatments include antibiotics, intravenous fluids, and vasopressors to maintain blood pressure. While TPE is being studied for its potential benefits in septic shock, it remains an investigational therapy rather than an FDA-approved standard treatment.

What other types of research exist?

Promising, novel alternatives to Therapeutic Plasma Exchange (TPE) for septic shock patients include extracorporeal immunoadsorption and hemoperfusion with polymyxin-B immobilized fiber. These therapies focus on removing harmful substances from the blood and may offer new avenues for treatment.

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Procedure

Therapeutic Plasma Exchange for Sepsis

Phase 1

Waitlist Available

Led By George F Alvarez, MD

Research Sponsored by Alberta Health Services, Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Noradrenaline >0.1 ug/kg/min to maintain MAP> 65mmHg for at least 4 consecutive hours and present at initiation of TPE

Adult patients (age ≥18) with a documented or strong clinical suspicion of infection that meets the definition of septic shock as per the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during course of icu stay, could be up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, TPE procedures can generally involve risks such as allergic reactions to replacement fluids, bleeding due to anticoagulants used during the process, infections at catheter sites, or changes in blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am an adult suspected of or diagnosed with septic shock.

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I have received more than 30 mls/kg in fluid resuscitation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during course of icu stay, could be up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during course of icu stay, could be up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and during course of icu stay, could be up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events

Discontinue TPE

Enrollment Rate

+1 more

Secondary study objectives

Days in ICU

Mortality

Organ dysfunction

+3 more

Side effects data

From 2011 Phase 3 trial • 37 Patients • NCT01210716

Paresthesia

Dizzy/Light-Headed

Headache

Infiltration

Chills

Rigors

Nausea

Fatigue

100%

80%

60%

40%

20%

Study treatment Arm

Overall Study Population

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TPE in Septic ShockExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Therapeutic plasma exchange

2020

Completed Phase 3

~80

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for septic shock include fluid resuscitation, antibiotic therapy, and therapeutic plasma exchange (TPE). Fluid resuscitation restores tissue perfusion by rapidly administering intravenous fluids to maintain blood pressure and organ function. Antibiotic therapy targets and eliminates the infection, reducing the bacterial load and inflammatory response. TPE involves removing the patient's plasma, which contains harmful substances like inflammatory mediators and endotoxins, and replacing it with IV fluids, albumin, or blood products. This helps reduce the systemic inflammatory response and improve hemodynamic stability. These treatments are crucial as they address both the infection and the resulting hemodynamic instability, key factors in reducing mortality and improving outcomes for septic shock patients.

Plasma Leak From the Circulation Contributes to Poor Outcomes for Preterm Infants: A Working Hypothesis.Extracorporeal blood treatment (EBT) methods in SIRS/Sepsis.