Blood Purification for the Treatment of Pathogen Associated Shock

Overview

About this study

This study is a multi-center, randomized controlled feasibility trial to evaluate the initial safety and effectiveness 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 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;
    • Presence of a pathogen detected in the bloodstream within 72 hours of screening using commercially available in-vitro diagnostic testing.
  • Male or non-pregnant female adult.
  • At least 18 years of age at time of enrollment.
  • Within 72 hours of admission to the ICU.

Exclusion Criteria:

  • Pregnant or breast feeding.
  • Anticipated transfer to another hospital (that is not a study site) within 72 hours for any reason.
  • Not anticipated to survive more than 24 hours.
  • Allergy to heparin sodium.
  • Patients who cannot tolerate placement of double-lumen catheter.
  • High risk of bleeding (platelet count < 50mm^3 or International normalized ratio > 1.5).
  • Inability to tolerate extra-corporeal therapy (defined as MAP < 65 despite fluids and vasopressors).
  • Advanced cancer (defined as stage IV).
  • Unable to obtain informed consent from either patient or legally authorized representative.
  • Hypotension and volume depletion due to etiologies other than sepsis.
  • Neutropenia with an absolute neutrophil count < 500mm^3.

Eligibility last updated 5/10/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kianoush Banaei Kashani, M.D., M.S.

Open for enrollment

Contact information:

Sharon Svoboda R.N.

(507) 255-8248

Svoboda.Sharon@mayo.edu

More information

Publications

Publications are currently not available