ACTIVE_NOT_RECRUITING

Blood Purification for the Treatment of Pathogen Associated Shock

Talk to us

Conditions

Septic Shockpathogen associated shock

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Blood Purification for the Treatment of Critically Ill Patients With Pathogen Associated Shock: A Multicenter, Randomized Controlled Feasibility Trial

Quick Facts

Study Start:2024-04-19
Study Completion:2025-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05011656

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Admitted to an ICU with pathogen associated shock defined as:
  2. * The need for vasopressors to maintain mean arterial pressure (MAP) ≥ 65 mmHg despite adequate fluid resuscitation, AND
  3. * Presence of a pathogen detected in the bloodstream within 72 hours of screening using commercially available in-vitro diagnostic testing
  4. 2. Male or non-pregnant female adult
  5. 3. At least 18 years of age at time of enrollment
  1. 1. Pregnant or breast feeding
  2. 2. Anticipated transfer to another hospital (that is not a study site) within 72 hours for any reason
  3. 3. Not anticipated to survive more than 24 hours
  4. 4. Known allergy to heparin sodium
  5. 5. Patients who cannot tolerate placement of double-lumen catheter
  6. 6. High risk of bleeding (platelet count \<50mm3 or International Normalized Ratio (INR) \>2) unless adequate line for treatment already placed (e.g. ECMO or RRT/CRRT)
  7. 7. Inability to tolerate extracorporeal therapy (defined as MAP\<65 despite fluids and vasopressors)
  8. 8. Advanced cancer (defined as stage IV) with life expectancy of less than 30 days
  9. 9. Unable to obtain informed consent from either patient or legally authorized representative (LAR)
  10. 10. Hypotension and volume depletion due to etiologies other than sepsis.
  11. 11. Neutropenia with an absolute neutrophil count \<500mm3
  12. 12. Patients must be treated with one of the antimicrobial agents listed in the Antimicrobial Management Guideline (Table 19). Patients who require treatment with an antimicrobial outside of this list while still receiving treatment with the investigational device must be excluded from the study.
  13. 13. If a patient enters the study and later requires a change in the antimicrobial agent used to one which is not listed in the Antimicrobial Management Guideline while still receiving treatment with the investigational device, that patient must be removed from this trial. Clinical data for any patient removed from the trial for this reason will continue to be collected for safety evaluation".
  14. 14. Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator or IRB/ethics committee.
  15. 15. Advanced directive for "Do Not Resuscitate".

Contacts and Locations

Principal Investigator

Lakhmir Chawla, MD
STUDY_CHAIR
ExThera Medical

Study Locations (Sites)

George Washington University
Washington, District of Columbia, 20037
United States
Southeast Georgia Health System, Inc.
Brunswick, Georgia, 31520
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Good Samaritan Hospital
Corvallis, Oregon, 97330
United States
Trinity Health Mid Atlantic-SMMC
Langhorne, Pennsylvania, 19047
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
Methodist Hospital
San Antonio, Texas, 78229
United States
University of Texas Health Science Center at San Antonio (UT Health San Antonio)
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: ExThera Medical Corporation

  • Lakhmir Chawla, MD, STUDY_CHAIR, ExThera Medical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-19
Study Completion Date2025-09-30

Study Record Updates

Study Start Date2024-04-19
Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

  • pathogen associated shock

Additional Relevant MeSH Terms

  • Septic Shock