Blood Purification for Septic Shock
(PURIFY-RCT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new blood purification treatment called Seraph-100, designed to aid critically ill patients experiencing septic shock, a severe reaction to infection. The trial aims to test the safety and effectiveness of this device, which filters harmful pathogens from the blood, alongside standard care practices. Participants must be in the ICU with septic shock, require medication to maintain blood pressure, and have a known infection in the blood. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatments for septic shock.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must be treated with specific antimicrobial agents listed in the Antimicrobial Management Guideline. If you need a different antimicrobial while in the trial, you will be removed from the study.
What prior data suggests that this blood purification therapy is safe for patients with septic shock?
Research has shown that the Seraph-100 device has been used in various situations and maintains a good safety record. In studies on its use for COVID-19, patients tolerated the device well, and researchers found no major safety issues. The Seraph-100 is also approved for emergency use in adults with serious infections, indicating it has passed safety checks for this purpose.
The device cleans the blood to remove harmful germs, aiding in early infection treatment. Although detailed information on side effects is lacking, studies and emergency use approval suggest it is generally safe for adults.12345Why are researchers excited about this trial's treatment?
The Seraph-100 is unique because it offers a new way to combat septic shock by physically removing pathogens directly from the bloodstream. Unlike typical treatments that rely on antibiotics to fight infection, the Seraph-100 uses a special filter with heparin-coated beads to capture and reduce a broad range of pathogens during blood purification. This extracorporeal device is exciting researchers because it could work alongside existing care methods to rapidly decrease pathogen load, potentially improving outcomes in septic shock patients.
What evidence suggests that the Seraph-100 device is effective for septic shock?
Research has shown that the Seraph-100 device, which participants in this trial may receive, effectively reduces bacteria in the blood. In patients with heart infections who underwent surgery, the Seraph-100 significantly lowered bacteria levels. This treatment also stabilized blood pressure, crucial for patients in shock. Another study found that using Seraph-100 improved patient outcomes by reducing bacterial levels. These findings suggest that Seraph-100 may aid patients with severe infections by removing harmful germs from their blood.36789
Who Is on the Research Team?
Lakhmir Chawla, MD
Principal Investigator
ExThera Medical
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Seraph 100 treatment or 'State of the Art' care for up to 4 consecutive days
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at Day 7, Day 28, and 90 days post-enrollment
Pharmacokinetic Evaluation
First 15 patients undergo additional pharmacokinetic evaluation of antimicrobial removal by the filter treatment
What Are the Treatments Tested in This Trial?
Interventions
- Seraph-100
Seraph-100 is already approved in United States for the following indications:
- Pathogen-associated shock
- Sepsis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Henry M. Jackson Foundation for the Advancement of Military Medicine
Lead Sponsor
ExThera Medical Corporation
Lead Sponsor
Uniformed Services University of the Health Sciences
Collaborator