Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING NA

Blood Purification for the Treatment of Pathogen Associated Shock

NCT05011656 · View on ClinicalTrials.gov ↗

Study Summary

This study is a multi-center, randomized controlled feasibility trial to evaluate the initial safety and efficacy of a novel extracorporeal blood purification (EBP) therapy in critically ill patients with pathogen associated shock across 15 U.S. sites. Adults (18 years old and older) admitted to the ICU with all of the following: • Pathogen associated shock defined as: * The need for vasopressors to maintain mean arterial pressure (MAP) ≥ 65 mmHg despite adequate fluid resuscitation * Presence of a pathogen detected in the bloodstream within 72 hours of screening using commercially available in-vitro diagnostic testing

Conditions Studied

Interventions

  • DEVICE Seraph-100 + State of the Art Care
  • DEVICE State of the Art Care

Study Locations (9)

Texas

  • University of Texas Southwestern Medical Center — Dallas
  • Methodist Hospital — San Antonio
  • University of Texas Health Science Center at San Antonio (UT Health San Antonio) — San Antonio

District of Columbia

  • George Washington University — Washington D.C.

Georgia

  • Southeast Georgia Health System, Inc. — Brunswick

Michigan

  • University of Michigan — Ann Arbor

Minnesota

  • Mayo Clinic — Rochester

Oregon

  • Good Samaritan Hospital — Corvallis

Pennsylvania

  • Trinity Health Mid Atlantic-SMMC — Langhorne

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2024-04-19
Est. Completion 2025-09-30
Phase NA

Sponsor

ExThera Medical Corporation

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05011656

The ClinicalTrials.gov registry entry for NCT05011656 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ExThera Medical Corporation, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Septic Shock appearing as the primary indexed condition, and to 2 interventions — of which Seraph-100 + State of the Art Care is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05011656 reports 9 study locations spanning 7 distinct geographic areas — top geographies include Texas, District of Columbia, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05011656 about?

NCT05011656 is a clinical study titled "Blood Purification for the Treatment of Pathogen Associated Shock". This study is a multi-center, randomized controlled feasibility trial to evaluate the initial safety and efficacy of a novel extracorporeal blood purification (EBP) therapy in critically ill patients with pathogen associated shock across 15 U.S. sites. Adults (18 years old and older) admitted to the...

What is the current status of trial NCT05011656?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2024-04-19. Estimated completion is 2025-09-30.

What conditions does trial NCT05011656 study?

This clinical trial studies the following conditions: Septic Shock. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05011656?

The interventions under investigation include: Seraph-100 + State of the Art Care (DEVICE), State of the Art Care (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05011656?

This trial is sponsored by ExThera Medical Corporation, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05011656 being conducted?

This trial has 9 study locations across District of Columbia, Georgia, Michigan, Minnesota, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial