DENIS Study

Phase 3

• Conditions: Complicated parapneumonic pleural effusion; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

• Registration Number: RPCEC00000292
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-22
• Results First Posted: 2020-04-30
• Study Completion: 2022-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1) Patients of any sex, with ages between 1 and 18 years.
2) Patients diagnosed with complicated complicated parapneumonic pleural effusion, who meet any of these clinical criteria:
a) Complex pleural effusion, with septa, partitions or particles in suspension in the chest ultrasound that persists after 12 hours of placement of the pleural drainage.
b) Fibrin finding in the chest drainage placement procedure.
c) Appearance of septa, septa or fibrin within 10 days after drainage is placed.
3) Voluntariness of the parents or guardians of the patient, by signing the informed consent.

Exclusion Criteria

1) Post-operative of recent major surgery (first 48 hours).
2) Presence of bronchopleural fistula.
3) Active bleeding or blood dyscrasias or arteriovenous or aneurysmal malformations.
4) Patient with intracranial tumor or stroke.
5) Patients with endocarditis or with a history of heart disease.
6) Unstable or catecholamine resistant septic shock, multiple organ failure.
7) Treatment with KS in the last six months.
8) Patients with some risk condition of major bleeding (contraindications established for intravenous KS).
9) Decompensated chronic disease: diabetes mellitus, heart failure, hypertension, among others.
10) Pregnant or lactating patients at the time of inclusion in the study.
11) Patients with allergies to SK or any ingredient of the formulation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified