Phase 2
Completed N=44
Steroid Dosing by bioMARker Guided Titration in Critically Ill Patients With Pneumonia
Source: ClinicalTrials.gov NCT03852537 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcomePrimary: Timely Initiation of Corticosteroids and Implementation of Biomarker-titrated Corticosteroid Dosing — 20; 19 Participants
Summary
This research study is being done to determine the appropriate dose of steroids and the appropriate duration for steroid use to reduce inflammation in severe pneumonia needing a form of breathing support. This study seeks to compare usual care to a unique (individualized) dosing strategy. A marker of inflammation in the body will be measured in blood samples. This marker of inflammation is called C- reactive protein. The overall goal is to identify patients that will benefit most from steroid use and decrease use of steroids. The information collected from this study may provide information that may improve management of patients with severe pneumonia requiring a form of breathing support.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Timely Initiation of Corticosteroids and Implementation of Biomarker-titrated Corticosteroid Dosing |
20; 19 | — |
| SECONDARY Mortality |
1; 1 | — |
| SECONDARY Need for High Flow Nasal Cannula Oxygen |
7; 4 | 0.494 |
| SECONDARY Need for Noninvasive Mechanical Ventilation |
4; 2 | 0.666 |
| SECONDARY Need for Invasive Mechanical Ventilation |
3; 2 | 1.000 |
| SECONDARY Organ Failure |
3.0; 7.0; 3.0; 3.0; 3.0; 3.0 | — |
| SECONDARY New Onset Cardiac Arrhythmias |
0; 1 | 0.477 |
| SECONDARY Myocardial Injury |
8; 10 | 1.000 |
| SECONDARY Cardiovascular Dysfunction |
1; 1 | 1.000 |
| SECONDARY Occurrence of Hyperglycemia |
11; 18 | 0.011 sig |
| SECONDARY Occurrence of Delirium |
5; 5 | 1.000 |
| SECONDARY Occurrence of Secondary Infection |
0; 0 | — |
| SECONDARY ICU Admission |
10; 5 | 0.213 |
| SECONDARY Oxygen-free Days |
21.0; 24.0 | — |
Eligibility Criteria
For the Pneumonia arm of the study:
Inclusion Criteria
- Patients admitted to hospital with community acquired pneumonia.
- Acute respiratory failure SpO2/FiO2 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 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
Data sourced from ClinicalTrials.gov (NCT03852537). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.