What side effects are associated with this type of intervention?

Common treatments for septic shock include the use of polymyxin B hemoperfusion (PMX cartridge) for endotoxin removal, intravenous fluids, and antibiotics. Polymyxin B hemoperfusion can improve oxygenation but may cause side effects such as hypotension and thrombocytopenia. Intravenous fluids, while essential for restoring perfusion, can lead to fluid overload and pulmonary edema. Antibiotics are crucial for targeting infections but can result in adverse effects like allergic reactions, gastrointestinal disturbances, and the development of antibiotic resistance.

What prior FDA approvals exist?

The FDA has approved various treatments for septic shock, primarily focusing on supportive care and antibiotics. While specific FDA approvals for endotoxin removal therapies like the PMX cartridge are not detailed in the provided context, treatments such as polymyxin B hemoperfusion have been studied for their potential to remove endotoxins and improve outcomes in septic shock. Other supportive treatments include the use of intravenous fluids, vasopressors, and empiric antibiotics to manage the infection and maintain hemodynamic stability.

What other types of research exist?

Promising alternatives to PMX Cartridge for septic shock patients include hemoperfusion with polymyxin-B immobilized fiber, which has shown improved oxygenation and survival rates in patients with AE-IPF. Additionally, therapies targeting cytokine removal and modulation of the immune response, such as the use of high-dose systemic glucocorticoids, may also be considered. However, intravenous recombinant thrombomodulin is not recommended due to lack of survival benefit and increased bleeding risk.

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PMX Hemoperfusion for Septic Shock (TIGRIS Trial)

N/A

Recruiting

Research Sponsored by Spectral Diagnostics (US) Inc.

Eligibility Criteria Checklist

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

Must have

Phenylephrine > 0.4 mcg/kg/min

Vasopressin (any dose) in combination with another vasopressor listed above

Must not have

Body weight < 35 kg (77 pounds)

HIV infection in association with a last known or suspected CD4 count of <50/mm3

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests whether adding a blood-filtering device called the PMX cartridge to regular treatment helps patients with severe infections and organ failure. The device aims to remove harmful toxins from their blood.

Who is the study for?

Adults with endotoxemic septic shock who have low platelet counts, reduced urine output despite fluids, need vasopressors to maintain blood pressure, and are suspected or confirmed to have an infection. They must also show signs of organ dysfunction and not be on chronic dialysis or suffering from conditions like severe heart failure, recent heart attack, uncontrolled bleeding, major trauma within the last 36 hours, extreme white cell or platelet depletion.

What is being tested?

The trial is testing the safety and effectiveness of adding a Polymyxin B Hemoperfusion (PMX) cartridge treatment to standard care for patients with endotoxemic septic shock compared to standard care alone. It's a prospective study involving multiple centers where participants are randomly assigned to one of the two groups.

What are the potential side effects?

Potential side effects may include allergic reactions to Polymyxin B if sensitivity exists. Since it involves extracorporeal hemoperfusion (blood purification outside the body), there might be complications related to this procedure such as clotting issues or infections.

Eligibility Criteria

Inclusion Criteria

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

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I am on a high dose of Phenylephrine.

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I am taking vasopressin with another blood pressure medication.

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I need a machine to help me breathe through a tube.

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I've received a fluid boost of at least 30mL/kg in the last day.

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I am on a high dose of epinephrine.

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I needed strong medication to maintain my blood pressure for a short time.

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I am on a high dose of norepinephrine.

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I am on a high dose of dopamine medication.

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I am receiving more than 0.03 units/min of vasopressin.

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I am 18 years old or older.

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I am receiving IV antibiotics for a confirmed or suspected infection.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I weigh less than 35 kg (77 pounds).

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I am HIV positive with a recent CD4 count below 50.

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I do not have severe heart failure (NYHA Class IV or ejection fraction < 35%).

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My blood pressure remains low despite receiving medication and fluids.

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I have severe kidney disease and need regular dialysis.

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I have had a recent blood clot in my lung.

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I have not had significant uncontrolled bleeding recently.

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I received CPR with chest compressions during this hospital stay and did not immediately wake up.

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I have had severe burns covering a large part of my body within the last week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Day 28 mortality comparison

Secondary study objectives

Day 14 mortality comparison

Day 28 mortality comparison for patients on norepinephrine >0.1 mcg/kg/min

MAP comparison

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PMX TreatmentExperimental Treatment1 Intervention

Standard medical care for septic shock plus treatment with the PMX cartridge (twice approximately 24 hours apart)

Group II: ControlActive Control1 Intervention

Standard medical care alone

0 / 20Eligibility 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 aim to restore tissue perfusion, control infection, and modulate the immune response. Intravenous fluids and vasopressors are used to maintain blood pressure and ensure adequate tissue perfusion. Empiric broad-spectrum antibiotics are administered early to control the underlying infection. Additionally, treatments like the PMX cartridge focus on removing endotoxins from the bloodstream, which can reduce the overwhelming inflammatory response that characterizes septic shock. This is crucial for septic shock patients as it helps to stabilize hemodynamics, reduce organ dysfunction, and improve overall outcomes.