Chronic Obstructive Pulmonary Disease Exacerbation, COPD Exacerbation
Conditions
Keywords
COPD, furosemide, dyspnea, inhaled furosemide
Brief summary
The goal of this randomized controlled trial is to determine the effect of adding inhaled furosemide to the known treatment of patient with Chronic obstructive pulmonary disease (COPD) exacerbation. It primarily aims at studying its effect on: 1. Relief of dyspnea sensation 2. Length of hospital stay Participants will be receiving the standard therapy of COPD exacerbation plus either inhaled furosemide or inhaled saline over 3 days. They will be asked to: * Perform spirometry * Fill in dyspnea score * Do arterial blood gases (ABGs)
Interventions
DRUGFurosemide
40mg (4ml) of furosemide to be nebulized 3 times daily for 3 days
DRUGNormal saline
4ml of normal saline to be nebulized 3 times daily for 3 days
Sponsors
American University of Beirut Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Both medications will be prepared by the pharmacists, the only unblinded personnel in the study, as transparent solutions in similar syringes.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Diagnosed with COPD * Presenting with COPD exacerbation * Requiring hospitalization
Exclusion criteria
* Hemodynamically instability (systolic blood pressure ≤ 90mmHg, heart rate ≥ 120 or ≤ 50 Bpm) * Decreased level of consciousness * Non-invasive mechanical ventilation or intubation at the time of recruitment * \>5 liters of oxygen at the time of recruitment * Pregnant patients * Other primary pulmonary disease or heart failure exacerbation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in dyspnea score from baseline as assessed by visual analogue scale (VAS) | at 24 hours | Visual analogue scale is a scale from 0 to 10, where 0 means no dyspnea at all and 10 is the worse dyspnea ever |
| Change in length of hospital stay | From admission to hospital discharge, up to 1 year | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in heart rate from baseline | On days 0, 1 and 3 | — |
| Change in systolic and diastolic blood pressure from baseline | On days 0, 1 and 3 | — |
| Change in steroid dose | Through hospital stay, up till 1 year | — |
| Change in lung volumes from baseline as measured by bedside spirometer | On days 0, 1 and 3 | Forced expiratory volume in first second (FEV1) and forced vital capacity (FVC) |
| Change in mortality | Through hospital stay, up till 1 year | — |
| Number of patients with adverse events as documented by questionnaires | On days 1,2,3 | Including: kidney injury measured by Creatinine and urine output, electrolyte disturbances (sodium and potassium levels) |
| Change in the number of patients requiring intubation or non-invasive mechanical ventilation | Through hospital stay, up till 1 year | Measured by questionnaire |
| Change in Arterial blood gases | On days 0 and 1 | — |
Contacts
Primary ContactNivine Abou Dargham, MD
Backup ContactHisham Bou Fakhreddine, MD
Outcome results
None listed