Complicated parapneumonic pleural effusion
Conditions
Interventions
Group I (Experimental): Intravenous antibiotic therapy (according to unit protocol, pleural puncture and placement of chest drainage under local anesthesia and sedation, and assisted video-assisted th
Thrombolytic Therapy
Antibiotic Prophylaxis
Drainage
Thoracic Surgery, Video-Assisted
Administration, Intravenous
Intrapleural administration
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB)
Ministry of Public Health (MINSAP), Cuba
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Need for surgical treatment (video-assisted thoracoscopy surgery – VATS, thoracotomy with decortication), (Yes, No) due to failure of conventional or experimental therapy (SKr). 2) Hospital stay, given by the time (in days) from the diagnosis of complex complicated parapneumonic pleural effusion (CCPPE)/empyema to hospital discharge (patients were transferred to another ward upon leaving intensive care). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Resolution of the pleural effusion (in days) verified by chest x-ray in the anteroposterior position and chest ultrasound. Measurement time: daily until the spill is resolved. 2) Stay in intensive care: given by the time (in days) from the diagnosis of the condition under study until discharge (transfer) from intensive care. Measurement time: daily until discharge from intensive care. 3) Time of evolution (in days) of the complications accompanying CCPPE and empyema identified before the inclusion of the patient in the clinical trial. Measurement time: daily until the cessation of pre-inclusion complications. 4) Time of oxygen therapy/ventilator support requirement (in days). 5) Need (Yes, No) and time (in days) of oxygen therapy / ventilatory support requirement after the intervention in patients not ventilated at the time of inclusion in the study. If included in the trial with any ventilatory support, the time required (days) will be measured. Measurement time: daily during admission to intensive care. 6) Time (in days) to remove the chest drain from its insertion, due to resolution of the pleural effusion proven by chest x-ray and ultrasound. Measurement time: daily until drain extraction. 7) Post-fibrinolysis and post-VATS pleural drainage time (in days) from the end of fibronolytic or surgical therapy. Measurement time: daily until drain extraction. 8) Mortality (Yes, No). Measurement time: during the hospital stay. 9) Safety measured through the appearance of clinical adverse events (Occurrence of AE (Yes, No). Description of the AE (name of the event). Intensity of the AE (mild, moderate, severe). Causality (Unrelated, Doubtful, Possible, Probable, Definitive). Outcome (Completely resolved, Resolved with sequelae, Conditions in improvement, Condition present and unchanged, Worsening, Death caused by this event). | — |
Countries
Cuba
Contacts
Public ContactFrancisco Hernández Bernal
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed