Complicated Pleural Effusion/ EmpyemaNCT03716375
Efficacy of Fibrinolytic Agents in Complicated Pleural Effusion
A study testing Intrapleural Medications in people with Complicated Pleural Effusion/ Empyema, run by Beijing Children's Hospital.
Trial summary
Intrapleural administration of fibrinolytic therapy, urokinase in parapneumonic effusion and empyema has been shown to decrease the need for surgical intervention and length of hospital stay. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Complicated Pleural Effusion/ Empyema
- What is being tested?
- Intrapleural Medications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Previously healthy child with age between 1 month to 18 years
- Admitted with diagnosis of Pleural empyema requiring chest tube insertion and fibrinolytics (as judged by the attending physician) with the following criteria:
- Pneumonia with pleural empyema based on chest ultrasound and CT scan. II. Need for further intervention based on clinical criteria (persistent fever despite antibiotics for at least 48 hours, significant respiratory distress, tachypnea or hypoxia as a result of pleural empyema.
Who cannot join
- Subject will be excluded if she or he has one of the followings:
- Empyema as result of tuberculosis, fungus or noninfectious causes (e.g. malignancy)
- Known coagulation impairment
- Suspected allergy to urokinase
- Child has already undergone drainage procedure or drug was used in 30 days (e.g.
- chest tube or VATS
Show all 14Show fewer
- Chronic lung diseases or other chronic illnesses (e.g. Immunodeficiency, neurological impairment possible)
- Significant thoracic trauma in last 2 months
- Severe arterial hypertension
- Presence of Pneumothorax before treatment (i.e. bronchopleural fistula)
- Pregnancy
- Breast feeding
- Poor compliance
- Contraindication in the presence of fibrinolytic agent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Study of Fibrinolytic Treatment for Purulent Pleural Effusion in Children
Intrapleural administration of fibrinolytic therapy, urokinase in parapneumonic effusion and empyema has been shown to decrease the need for surgical intervention and length of hospital stay. Pleural adhesions are easily formed in the early stages of empyema and the thickening of the pleural causes subsequent treatment difficulties. The goal of this study was to observe and compare the efficacy of treatment in empyema patients with urokinase and chest drainage or with chest drainage or with chest tube drainage alone so as to provide evidence for guiding clinical treatment.
Read the detailed description
Empyema, a collection of pus in the pleural space has been continuously associated with morbidity and mortality rates of 10-20%. Increase in the incidence of empyema with change in pattern of disease and the causative organism has demonstrated a challenge in the diagnosis and treatment. In the recent years many studies and clinical trials have been done among adults and children regarding the optimal empyema treatment and its efficacy and some are still in the process of further study. Appropriate treatment according to the three stages of empyema (i.e. exudative stage, fibropurulent stage and organizing stage) has constantly been under frequent research, finding which treatment is more effective (i.e. antibiotics, chest tube drainage, intrapleural fibrinolytics, VATS and decortication alone in combination) and when is the proper time for intervention. Intrapleural instillation of urokinase was initially described in 1994 on pediatric population and since then lots of studies have been reported. Therefore, the investigators conducted a randomized controlled study with relevant inclusion and exclusion criteria to assess the success rate of intrapleural urokinase administration among the patients with Complicated Pleural Effusion (CPE) / empyema comparing it with drainage alone. All case patients in this study received antibiotic empirically or with sensitivity when microbiological tests available, chest tube drainage along with urokinase intrapleural therapy or drainage alone for treatment of CPE/empyema.
Patients will be randomized into two groups: one is chest tube drainage and intrapleural fibrinolytic agent and another is chest tube drainage alone. The group with intrapleural fibrinolytic agent will receive urokinase 10ml of 1000 IU/ml in children aged less than or equal to 1 year or 40ml of 1000 IU/ml in children aged more than 1 year and the other group with drainage alone. The first instillation of the agent is done at the time of chest tube insertion of 12Fr or 14Fr tube, after instillation the chest tube is closed for 4 hours. The chest tube is then unclamped after 4 hours and connected to the suction system with pressure of -20cm H2O for 8 hours and the process is repeated every 12 hourly. The procedure was done for 3 consecutive days and was evaluated with daily chest X-ray and followed chest tube removal when the drainage was less than 40ml/day or according to the clinical and radiological response of patients with treatment.
The trial is being done for 12 months with 80 participants taken from one center, Beijing children´s Hospital.
The aim of this study is to evaluate difference among intrapleural urokinase as the initial treatment for children with pleural empyema against chest tube drainage alone. Length of hospital stay, number of days chest tube drainage, number of days of fever after tube insertion, complications such bleeding, chest pain will be compared between the two groups.
- Conditions
- Complicated Pleural Effusion/ Empyema
- Being tested
- Intrapleural Medications
- Keywords
- Pleural empyema, urokinase
- Medical subject headings
- Empyema, Pleural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrapleural MedicationsDrug
urokinase
| Study group | Role | What they receive |
|---|---|---|
| use of fibrinolytic agent | Experimental | Chest tube drainage with intrapleural urokinase instillation 1000 IU/ml Receives: Drug: Intrapleural Medications |
| no use of any drug | No intervention | Chest tube drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Measured: 2 weeks
Secondary outcomes (4)
Days of fever after chest tube insertion
Measured: 3 to 4 days
Duration of drainage
Measured: 2 weeks
Complications
number of participants changed to open thoracotomy
Measured: 2weeks
Failure rate
Measured: 2weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study startNov 2018 (estimated)
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Complicated Pleural Effusion/ EmpyemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baoping XU, Beijing Children's Hospital
- Investigators
- Xu Baoping, MD, PhD, Principal investigator, Beijings Children´s Hospital of Capital Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716375
- Sponsor's protocol ID
- BCHlung011
- Status last verified
- Oct 2018
- First submitted
- 7 Oct 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shirota C, Uchida H. Initial treatment of septated parapneumonic empyema with drainage plus fibrinolytic agents is equally effective as video-assisted thoracoscopic surgery, and is suitable as first-line therapy. Transl Pediatr. 2015 Jan;4(1):41-4. doi: 10.3978/j.issn.2224-4336.2015.02.01.
PubMed 26835359Stefanutti G, Ghirardo V, Barbato A, Gamba P. Evaluation of a pediatric protocol of intrapleural urokinase for pleural empyema: a prospective study. Surgery. 2010 Sep;148(3):589-94. doi: 10.1016/j.surg.2010.01.010. Epub 2010 Mar 20.
PubMed 20304453Walker W, Wheeler R, Legg J. Update on the causes, investigation and management of empyema in childhood. Arch Dis Child. 2011 May;96(5):482-8. doi: 10.1136/adc.2009.165357. Epub 2010 Aug 24.
PubMed 20736395
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Fibrinolytic Treatment for Purulent Pleural Effusion in Children
- ClinicalTrials.gov ID
- NCT03716375
- Acronym / sponsor ID
- BCHlung011
- Conditions
- Complicated Pleural Effusion/ Empyema
- Keywords
- Pleural empyema, urokinase
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intrapleural administration of fibrinolytic therapy, urokinase in parapneumonic effusion and empyema has been shown to decrease the need for surgical intervention and length of hospital stay. Pleural adhesions are easily formed in the early stages of empyema and the thickening of the pleural causes subsequent treatment difficulties. The goal of this study was to observe and compare the efficacy of treatment in empyema patients with urokinase and chest drainage or with chest drainage or with chest tube drainage alone so as to provide evidence for guiding clinical treatment.
Detailed description
Empyema, a collection of pus in the pleural space has been continuously associated with morbidity and mortality rates of 10-20%. Increase in the incidence of empyema with change in pattern of disease and the causative organism has demonstrated a challenge in the diagnosis and treatment. In the recent years many studies and clinical trials have been done among adults and children regarding the optimal empyema treatment and its efficacy and some are still in the process of further study. Appropriate treatment according to the three stages of empyema (i.e. exudative stage, fibropurulent stage and organizing stage) has constantly been under frequent research, finding which treatment is more effective (i.e. antibiotics, chest tube drainage, intrapleural fibrinolytics, VATS and decortication alone in combination) and when is the proper time for intervention. Intrapleural instillation of urokinase was initially described in 1994 on pediatric population and since then lots of studies have been reported. Therefore, the investigators conducted a randomized controlled study with relevant inclusion and exclusion criteria to assess the success rate of intrapleural urokinase administration among the patients with Complicated Pleural Effusion (CPE) / empyema comparing it with drainage alone. All case patients in this study received antibiotic empirically or with sensitivity when microbiological tests available, chest tube drainage along with urokinase intrapleural therapy or drainage alone for treatment of CPE/empyema.
Patients will be randomized into two groups: one is chest tube drainage and intrapleural fibrinolytic agent and another is chest tube drainage alone. The group with intrapleural fibrinolytic agent will receive urokinase 10ml of 1000 IU/ml in children aged less than or equal to 1 year or 40ml of 1000 IU/ml in children aged more than 1 year and the other group with drainage alone. The first instillation of the agent is done at the time of chest tube insertion of 12Fr or 14Fr tube, after instillation the chest tube is closed for 4 hours. The chest tube is then unclamped after 4 hours and connected to the suction system with pressure of -20cm H2O for 8 hours and the process is repeated every 12 hourly. The procedure was done for 3 consecutive days and was evaluated with daily chest X-ray and followed chest tube removal when the drainage was less than 40ml/day or according to the clinical and radiological response of patients with treatment.
The trial is being done for 12 months with 80 participants taken from one center, Beijing children´s Hospital.
The aim of this study is to evaluate difference among intrapleural urokinase as the initial treatment for children with pleural empyema against chest tube drainage alone. Length of hospital stay, number of days chest tube drainage, number of days of fever after tube insertion, complications such bleeding, chest pain will be compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| use of fibrinolytic agent | Experimental | Drug: Intrapleural MedicationsChest tube drainage with intrapleural urokinase instillation 1000 IU/ml |
| no use of any drug | No intervention | –Chest tube drainage |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Previously healthy child with age between 1 month to 18 years
- Admitted with diagnosis of Pleural empyema requiring chest tube insertion and fibrinolytics (as judged by the attending physician) with the following criteria:
- Pneumonia with pleural empyema based on chest ultrasound and CT scan. II. Need for further intervention based on clinical criteria (persistent fever despite antibiotics for at least 48 hours, significant respiratory distress, tachypnea or hypoxia as a result of pleural empyema.
Key exclusion criteria (14 listed)
- Empyema as result of tuberculosis, fungus or noninfectious causes (e.g. malignancy)
- Known coagulation impairment
- Suspected allergy to urokinase
- Child has already undergone drainage procedure or drug was used in 30 days (e.g.
- chest tube or VATS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrapleural Medicationsurokinase | Drug | use of fibrinolytic agent |
Primary outcome
Length of hospital stay
Time frame: 2 weeks
4 secondary outcomes
Days of fever after chest tube insertion
Time frame: 3 to 4 days
Duration of drainage
Time frame: 2 weeks
Complications
Time frame: 2weeks
Failure rate
Time frame: 2weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Results publication: PubMed 26835359Shirota C, Uchida H. Initial treatment of septated parapneumonic empyema with drainage plus fibrinolytic agents is equally effective as video-assisted thoracoscopic surgery, and is suitable as first-line therapy. Transl Pediatr. 2015 Jan;4(1):41-4. doi: 10.3978/j.issn.2224-4336.2015.02.01.
- Results publication: PubMed 20304453Stefanutti G, Ghirardo V, Barbato A, Gamba P. Evaluation of a pediatric protocol of intrapleural urokinase for pleural empyema: a prospective study. Surgery. 2010 Sep;148(3):589-94. doi: 10.1016/j.surg.2010.01.010. Epub 2010 Mar 20.
- Results publication: PubMed 20736395Walker W, Wheeler R, Legg J. Update on the causes, investigation and management of empyema in childhood. Arch Dis Child. 2011 May;96(5):482-8. doi: 10.1136/adc.2009.165357. Epub 2010 Aug 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xu Baoping, MD, PhD principal investigator
Beijings Children´s Hospital of Capital Medical University, China
Questions about this trial
What is this clinical trial studying?
A study testing Intrapleural Medications in people with Complicated Pleural Effusion/ Empyema, run by Beijing Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu Baoping, MD, PhD (+861059616308, xubaopingbch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03716375, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.