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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 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

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.

Find a Location

Who is running the clinical trial?

Spectral Diagnostics (US) Inc.Lead Sponsor
3 Previous Clinical Trials
450 Total Patients Enrolled
3 Trials studying Septic Shock
450 Patients Enrolled for Septic Shock

Media Library

Toraymyxin PMX 20R Extracorporeal Hemoperfusion Cartridge Clinical Trial Eligibility Overview. Trial Name: NCT03901807 — N/A
Septic Shock Research Study Groups: PMX Treatment, Control
Septic Shock Clinical Trial 2023: Toraymyxin PMX 20R Extracorporeal Hemoperfusion Cartridge Highlights & Side Effects. Trial Name: NCT03901807 — N/A
Toraymyxin PMX 20R Extracorporeal Hemoperfusion Cartridge 2023 Treatment Timeline for Medical Study. Trial Name: NCT03901807 — N/A
~25 spots leftby Oct 2025