Interventional study to evaluate the efficacy of intrapleural sodium bicarbonate in empyema

JRCT ID: jRCTs031240093

Registered date:17/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: acute empyema and complicated parapneumonic effusions
• Date of first enrollment: 03/10/2024
• Target sample size: 25
• Study type: Interventional
• Intervention(s): 50 ml of sodium bicarbonate injection solution is administered into the thoracic cavity through the thoracic drain's double-lumen catheter, and the thoracic drain is clamped. The patient is repositioned every 30 minutes, the thoracic drain is released after 2 hours, and continuous thoracic drainage is performed at -15 cmH2O. This procedure should be performed once daily. If there is residual pleural effusion on chest X-ray the day after administration, this procedure should be performed for up to 3 days.

Outcome(s)

• Primary Outcome: Avoidance rate of surgery or death
• Secondary Outcome: Days with fever, days with chest drain, changes in chest X-ray findings, changes in white blood cell count, neutrophil count, and CRP

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Men and women who are at least 18 years old at the time of registration
2. Patients diagnosed with acute empyema and complicated parapneumonic effusions (diagnostic criteria: clinically evident bacterial infection with pleural effusion and one or more of the following. Imaging evidence of pleural effusion encapsulation, positive pleural fluid Gram stain or culture, pleural fluid pH <7.2, pleural fluid sugar <40 mg/dl, pleural fluid LDH >1000 IU/L, gross findings of pleural fluid is pus)
3. Administer antimicrobials and continuous thoracic drainage. Patients with residual pleural effusion on chest x-ray at least 12 hours after initiating continuous thoracic drainage (-15 cmH2O).
4. Patients who give written consent to participate in this study. Consent of a surrogate (spouse, guardian, or other equivalent) is also acceptable.

Exclude criteria

1. Patients with fistulous empyema
2. Patients with renal dysfunction (estimated Clearatin clearance less than 30 ml/min)
3. Patients with severe cardiac disease in the past
4. Patients with congestive heart failure requiring treatment
5. Patients with a history of severe respiratory dysfunction
6. Patients with coagulation abnormalities or patients taking anticoagulants
7. Patients with alkalemia (pH level of 7.45 or more on venous blood gas)
8. Patients with a serum sodium level of 150 mEq/L or more
9. Patients with a serum potassium level less than 3.0 mEq/L
10. Patients with a serum calcium level less than 8.0 mg/dL
11. Patients with septic shock
12. Pregnant or lactating women
13. Patients who have received unapproved drugs within 12 weeks
14. Other patients who are judged to be inappropriate by the physician

Related Information

• Primary Sponsor: Teranishi Shuhei