Steroid Dosing by bioMARker Guided Titration in Critically Ill Patients With Pneumonia
Pneumonia
About this trial
This is an interventional treatment trial for Pneumonia focused on measuring Pneumonia, steroid, COVID-19, SARS CoV-2
Eligibility Criteria
For the Pneumonia arm of the study:
Inclusion Criteria:
- Patients admitted to hospital with community acquired pneumonia.
- Acute respiratory failure SpO2/FiO2 < 315 (SpO2<90% on room air or <97% on 2L NC).
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 microgram/kilogram/minute or 2 or more vasopressors
- Pre-admission chronic use of steroids or other immunosuppressive medications
- Adrenal insufficiency
- Comfort care
- Leukopenia <1000/mm or neutropenia <500/mm (except if attributable to pneumonia) and HIV positive with a CD4 count <100
- Recent or past history of bone marrow or solid organ transplantation
- Hospital admission in the previous 30 days
- Suspected flare of Interstitial lung disease (infectious and non-infectious)
- Positive influenza testing or high suspicion for influenza
For the COVID-19 arm of the study:
Inclusion Criteria:
- Patients admitted to hospital with COVID-19 pneumonia (high suspicion or confirmed by positive SARS CoV-2 testing).
- Acute respiratory failure SpO2/FiO2 < 315 (SpO2<90% on room air or <97% on 2L NC).
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 microgram/kilogram/minute or 2 or more vasopressors
- Pre-admission chronic use of steroids or other immunosuppressive medications
- Adrenal insufficiency
- Comfort care
- Leukopenia <1000/mm or neutropenia <500/mm (except if attributable to pneumonia) and HIV positive with a CD4 count <100
- Recent or past history of bone marrow or solid organ transplantation
- Suspected flare of Interstitial lung disease (infectious and non-infectious)
- Positive influenza testing or high suspicion for influenza
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Usual Care
Biomarker-adjusted Steroid Dosing
Usual care as determined by the patient's primary team.
Individualized, biomarker concordant steroid use: dosing, titration and duration according to CRP level. This is a predetermined dosing table that adjusts dose of steroid by CRP level. Specifically: if CRP < 50 mmol/L: discontinue steroid; if CRP is between 51-100 mmol/L: 0.5 mg methylprednisolone (or dose equivalent of oral prednisone); if CRP is between 101-150 mmol/L: 0.75 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level is between 151-200 mmol/L: 1 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level > 200 mmol/L: 1.5 mg/kg methylprednisolone (or dose equivalent of oral prednisone).