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NCT05011656 · ClinicalTrials.gov registry record · NA
Blood Purification for the Treatment of Pathogen Associated Shock
A NA study of Septic Shock, sponsored by ExThera Medical Corporation.
- Active
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 9
- Study locations
NCT05011656: Active NA study of Septic Shock, sponsored by ExThera Medical Corporation.
NCT05011656 is a NA study of Septic Shock that is active but no longer recruiting, run by ExThera Medical Corporation. The registered enrollment target is 15 participants, below the 5,059-participant average among 24 other Septic Shock trials with a reported enrollment target (100% lower). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05011656, a NA study of Septic Shock, is active but no longer recruiting, sponsored by ExThera Medical Corporation.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 9
- Study locations
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
Primary Outcome
Alive and not in the ICU (for at least a fulle 24 hours) in the first 28 days from the time of randomization
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
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-04-19 |
| Est. Completion | 2025-09-30 |
| Phase | NA |
What the registry record for NCT05011656 still lists
NCT05011656 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 5,059-participant average among 24 other Septic Shock trials with a reported enrollment target (100% lower).
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.
NCT05011656 lists 9 locations in 7 states (Texas, District of Columbia, Georgia).
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.
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).
Who is sponsoring clinical trial NCT05011656?
This trial is sponsored by ExThera Medical Corporation, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Septic Shock
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05011656's enrollment target sits among peer trials
15 24th of 24 higher than 1 of 24 other Septic Shock trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Septic Shock trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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External Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients
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-
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-
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COMPLETED · NA
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