Pleuritis, Non-specific
Conditions
Brief summary
This research study aims to evaluate whether corticosteroids help prevent the recurrence of pleural effusions in patients with non-specific pleuritis diagnosed through pleural biopsy. It can lead to recurrent fluid buildup in the lungs, causing discomfort and requiring additional medical interventions. There is no established treatment to prevent recurrence, and this study seeks to determine whether steroids reduce fluid buildup or cause complications. There will be two groups: one receiving corticosteroids (standard of care in the institution) and one not receiving corticosteroids (intervention group). The participation will last approximately 6 months, with in-person visits every 2 weeks for the first month, then monthly, along with possible telephone follow-ups. The study will monitor for pleural effusion recurrence, need for additional procedures, and potential side effects of corticosteroids. This is a pilot study. Although there are forty people expected to take part in this research study based on institutional data, the number of patients included in the study will be determined by the number of patients with non-specific pleuritis diagnosed during the study period.
Interventions
DRUGCorticosteroid
Patients take 40 mg of prednisone daily for 4 weeks to help reduce inflammation.
OTHERNo Corticosteroid
Patients do not take corticosteroid.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All adult patients with diagnosis of non-specific pleuritis as determined by pleural biopsy with a negative serologic autoimmune profile (ANA, ANCA, anti-DS DNA, anti-SS A/B, anti-centromere, RF, anti-CCP) are eligible
Exclusion criteria
* Chronic/fibrinous pleuritis * Positive autoimmune serologic workup * A contraindication to corticosteroids * Empyema * Patients already receiving corticosteroids or other immunosuppressive medications for any other indication * Inability to obtain informed consent due to cognitive, neurologic or psychiatric impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients screened | every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months | Screened defined as how many patients are evaluated for participation |
| Number of patients enrolled | every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months | Enrolled defined as how many screened patients actually join the study |
| Number of patients retained | every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months | Retention defined as how many enrolled patients continue participating over time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of recurrence | every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months | Incidence of recurrent pleural effusions attributable to symptoms requiring an intervention |
Countries
United States
Contacts
CONTACTAxel Duval, MD
PRINCIPAL_INVESTIGATORUdit Chaddha, MBBS
Icahn School of Medicine
Outcome results
None listed