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Safety and efficacy of sodium bicarbonate intrathoracic irrigation in the treatment of complex pleural effusion: a prospective, multicenter, single-blind, randomized controlled study

Safety and efficacy of sodium bicarbonate intrathoracic irrigation in the treatment of complex pleural effusion: a prospective, multicenter, single-blind, randomized controlled study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084312
Enrollment
Unknown
Registered
2024-05-14
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex pleural effusion

Interventions

Group A:Given 200ml of normal saline daily by intrathoracic injection
Group B:Given 200ml of 2.5% sodium bicarbonate daily by intrathoracic injection (5% sodium bicarbonate 1:1 with normal saline).

Sponsors

The First Affiliated Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Hospitalized patients aged 18-80 years (including 18 and 80 years). 2) Meet any of the three criteria for complex pleural effusion: A.PH 1000IU/L; C. pleural fluid etiological culture or smear positive. 3) Patients with pleural effusion >300ml (calculated according to CT pleural effusion image range D2*L, D maximum depth, L maximum length) and it is necessary to perform pleural effusion drainage according to clinical guidelines or standards.

Exclusion criteria

Exclusion criteria: 1) The causes of pleural effusion were hospital-acquired disturbance, tuberculous pleural effusion, fungal infection-associated pleural effusion, or non-infectious pleural effusion 2) Inability to tolerate intrathoracic administration or allergy to sodium bicarbonate 3) There is contraindication of thoracentesis catheterization for coagulation dysfunction 4) The combination of other chronic lung diseases may lead to poor antibiotic treatment and interfere with outcome judgment (e.g., uncontrolled COPD (GOLD E group), bronchiectasis, immune deficiency) or long-term use of glucocorticoids due to chronic disease 5) Concurrent shock, massive bleeding, major trauma or lung surgery within the last 5 days 6) A history of lung or pleural surgery on the pleural effusion side 7) Patients who have recently undergone thoracic catheterization due to pneumothorax or surgery or pleural effusion 8) Pregnant or lactating women 9) Patients who are currently participating in a clinical trial of any other drug or device 10) Patients with poor compliance are either difficult to follow up or can expect to survive less than 3 months due to diseases other than pleural effusion

Design outcomes

Primary

MeasureTime frame
Surgical referral rate;

Secondary

MeasureTime frame
Length of hospital stay;Change rate of pleural thickness before and after treatment;All-cause mortality;WBC;neutrophilic granulocyte percentage;CRP;PCT;IL-6;The amount of pleural fluid;

Countries

China

Contacts

Public ContactCao Chao

The First Affiliated Hospital of Ningbo University

caocdoctor@163.com+86 182 5879 6161

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026