A Study to Assess Steroid Dosing by bioMARker Guided Titration in Critically Ill Patients With Pneumonia

Overview

About this study

The purpose of this study is to compare a standard steroid dosing algorithm to a novel biomarker-tailored steroid dosing algorithm for patients receiving corticosteroids for community acquired pneumonia.  Patients with severe community acquired pneumonia may benefit from adjunctive corticosteroid therapy. The optimal patient selection, dosing and duration of steroids is unknown.

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: 

  • Emergency Room patients with pneumonia and acute respiratory failure defined by SpO2/FiO2 < 315 (SpO2 < 90% on room air or < 97% on 2L/minute O2) within 48 hours of ED presentation or admission.
  • Emergency Room patients diagnosed with COVID-19.

Exclusion Criteria:

  • Contraindications or unwilling to use steroids by patient or provider.
  • Refractory septic shock defined as a requirement of norepinephrine dose or equivalent above > 0.1 mcg/kg min or 2 or more vasopressors.
  • Pre-admission chronic use of steroids or other immunosuppressive medications.
  • Recent or past history of bone marrow or solid organ transplantation.
  • Adrenal insufficiency, as noted in the problem list/medical history.
  • Comfort care.
  • Hospital admission in the previous 30 days.
  • Leukopenia < 1000/mm or neutropenia < 500/mm (except if attributable to pneumonia) and HIV positive with a CD4 count <100.
  • Suspected flare of Interstitial lung disease  (infectious and non-infectious).
  • Positive influenza testing or high suspicion for influenza.

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

Hemang Yadav, M.B.B.S.

Open for enrollment

Contact information:

Anesthesia Clinical Research Unit

(507) 422-0582

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20478016

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