The goal of this clinical trial is to evaluate the safety and efficacy of sodium bicarbonate pleural lavage in treating complex pleural effusion in adult. The main questions it aims to answer are:
Will sodium bicarbonate pleural lavage reduce the failure rate of medical treatment (referral rate for surgery) for complicated pleural effusion？ Can sodium bicarbonate pleural lavage accelerating the rehabilitation of patients with complicated pleural effusion？ Will sodium bicarbonate pleural lavage improve the prognosis of patients with complicated pleural effusion?
Participants will will undergo catheter placement for continuous drainage of pleural effusion. Once at least 200 mL of pleural effusion has been drained:
Group A: Participants will receive a daily intrapleural injection of 200 mL of saline in 7 days; Group B: Participants will receive a daily intrapleural injection of 200 mL of 2.5% sodium bicarbonate in 7 days.
Hospitalized patients aged 18 to 80 years, inclusive.
Patients fulfilling any one of the following three criteria for complicated pleural effusion: A. Pleural fluid pH < 7.2; B. Pleural fluid glucose < 2.2 mmol/L and LDH > 1000 IU/L; C. Positive pleural fluid culture or smear for pathogens.
Pleural effusion volume exceeding 300 mL, as determined by CT imaging using the formula D² * L (where D represents the maximum depth and L the maximum length), and for whom pleural effusion drainage is clinically indicated according to established guidelines or criteria.
Patients with known allergies to sodium bicarbonate or normal saline.
Patients with severe coagulation disorders.
Patients with severe heart or kidney failure.
Pregnant or lactating women.
Parallel
Sodium bicarbonate pleural lavage
DrugAll participants will receive a standardized antimicrobial therapy regimen, with antibiotics selected based on susceptibility testing. Within 2 days of initiating treatment, all patients will undergo catheter placement for continuous drainage of pleural effusion. Participants will receive a daily intrapleural injection of 200 mL of 2.5% sodium bicarbonate in 7 days. For patients with ultrasound evidence of pleural effusion loculations or drainage tube obstruction, intrapleural administration of urokinase may be performed at the discretion of the treating physician to ensure effective drainage.Following each daily injection, the catheter will be clamped for 2 hours before resuming continuous drainage, a process that will continue for 7 days.
Saline pleural lavage
DrugAll participants will receive a standardized antimicrobial therapy regimen, with antibiotics selected based on susceptibility testing. Within 2 days of initiating treatment, all patients will undergo catheter placement for continuous drainage of pleural effusion. Participants will receive a daily intrapleural injection of 200 mL of saline in 7days For patients with ultrasound evidence of pleural effusion loculations or drainage tube obstruction, intrapleural administration of urokinase may be performed at the discretion of the treating physician to ensure effective drainage. Following each daily injection, the catheter will be clamped for 2 hours before resuming continuous drainage, a process that will continue for 7 days..
Failure rate of medical treatment (referral rate for surgery)
Change in Pleural Thickness Before and After Treatment
Volume of Pleural Effusion Before and After Treatment
Average Length of Hospital Stay
Inflammatory Response at 1 Week and 2 Weeks Post-Treatment
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