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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

TIGRIS Trial Summary

This trial is testing whether adding a PMX cartridge to standard care can help improve outcomes for patients with septic shock caused by endotoxemia.

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.Check my eligibility

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.See study design

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.

TIGRIS Trial 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.

TIGRIS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Day 28 mortality comparison

Secondary outcome measures

Day 14 mortality comparison

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

MAP comparison

+3 more

TIGRIS 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 / 11Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for participants in this research?

"Per the data on clinicaltrials.gov, this research endeavour is recruiting participants to participate in its trial activities. This study was initially posted on October 17th 2019 and underwent a revision process as recently as October 18th 2022."

Answered by AI

In how many venues is this experiment being conducted?

"The current locations for this scientific inquiry include Cleveland Clinic in Cleveland, Cooper Health System in Camden and West virginia University in Morgantown. Furthermore, there are 14 other sites offering the same study across America."

Answered by AI

What is the aggregate size of the patient population participating in this research program?

"Affirmative, the information listed on clinicaltrials.gov reveals that this study is still enrolling patients. It was first posted in October 17th 2019 and most recently updated on October 18th 2022; it requires 150 participants from 14 different medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized, Open-Label Study

2019. "Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized, Open-Label Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03901807.

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