An interventional study of Sodium bicarbonate pleural lavage and Saline pleural lavage in Complicated Pleural Effusion/ Empyema, sponsored by First Affiliated Hospital of Ningbo University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by First Affiliated Hospital of Ningbo University · Not applicable, Interventional, and Treatment
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.
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.
38 studies on the registry are indexed under Empyema; 11 are open to participants now.
This study's planned enrollment of 260 is above the median of 92 across 28 interventional studies indexed under Empyema.
Browse Empyema studies →First Affiliated Hospital of Ningbo University is the lead sponsor of 27 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a daily intrapleural injection of 200 mL of saline in 7 days besides standard antibiotic therapy.
Drug: Saline pleural lavage
Participants will receive a daily intrapleural injection of 200 mL of 2.5% sodium bicarbonate in 7 days besides standard antibiotic therapy.
Drug: Sodium bicarbonate pleural lavage
All 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.
All 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)
Time frame: Week 2.
Change in Pleural Thickness Before and After Treatment
Time frame: Baseline, week 2, week 12 and 3-month follow up.
Volume of Pleural Effusion Before and After Treatment
Time frame: Baseline, week 2, week 12 and 3-month follow up.
Average Length of Hospital Stay
Time frame: Up to 3 months.
Inflammatory Response at 1 Week and 2 Weeks Post-Treatment
Time frame: Baseline, week 1 and week 2.
All-Cause Mortality
Time frame: Up to 3 months.
Plan to share: No
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First Affiliated Hospital of Ningbo University