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Blood Purification

Blood Purification for Septic Shock (PURIFY-RCT Trial)

N/A

Recruiting

Research Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine

Eligibility Criteria Checklist

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

Must have

Admitted to an intensive care unit (ICU) with pathogen associated shock defined as: The need for vasopressors to maintain mean arterial pressure (MAP) ≥ 65 mmHg despite adequate fluid resuscitation

At least 18 years of age at time of enrollment.

Must not have

Inability to tolerate extra-corporeal therapy (defined as MAP<65 despite fluids and vasopressors).

Advanced cancer (defined as stage IV).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a special blood filter device in critically ill adults with severe infection and shock. The device works by filtering the blood outside the body to remove harmful substances, aiming to improve patient outcomes.

Who is the study for?

Adults in the ICU with pathogen associated shock, needing drugs to maintain blood pressure after fluid resuscitation and having a detected bloodstream pathogen. Excludes those unlikely to survive 24 hours, at high bleeding risk, intolerant to extracorporeal therapy, with advanced cancer or neutropenia, pregnant/breastfeeding women, or allergic to heparin.

What is being tested?

The trial is testing Seraph-100 plus standard care against standard care alone for treating critically ill patients with shock due to pathogens. It's conducted across 15 U.S. sites and randomly assigns participants into two groups.

What are the potential side effects?

Potential side effects of Seraph-100 are not specified but may include typical risks associated with extracorporeal therapies such as bleeding complications or reactions related to blood purification processes.

Eligibility Criteria

Inclusion Criteria

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

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I was in the ICU needing drugs to keep my blood pressure up despite getting enough fluids.

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I am 18 years old or older.

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I was admitted to the ICU less than 3 days ago.

Exclusion Criteria

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

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I cannot undergo treatments outside my body due to low blood pressure.

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My cancer is at stage IV.

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I have low blood pressure and dehydration not caused by an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 90 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

Efficacy - ICU-free days in the first 28 days

Safety - Adverse Events

Secondary study objectives

Hospital Stay

Kidney replacement therapy-free days in the first 28 days

Mortality

+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: 1- Seraph-100 plus State of the Art CareExperimental Treatment1 Intervention

The Seraph 100 Filter is a single use, disposable column packed with ultra-high molecular weight polyethylene beads which have been modified to contain endpoint attached heparin on the surface. Seraph 100 is an extracorporeal broad-spectrum sorbent hemoperfusion device for reduction of pathogens from the bloodstream. It is intended for use with standard, commercially available bloodlines compatible with the pump system used. Female Luer connectors are required to connect to the Seraph 100 blood ports.

Group II: 2 - State of the Art CareActive Control1 Intervention

"State of the Art care"is defined as the treatment algorithms outlined in the Surviving Sepsis Campaign for the treatment of septic shock, available at https://www.sccm.org/SurvivingSepsisCampaign/Home

0 / 6Eligibility criteria met