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Empyema clinical trials

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NCT ID: NCT02014077 Completed - Empyema Clinical Trials

VATS ( Video-Assisted Thoracoscopy) Compared to Reinsertion of a Thoracostomy Tube for Persistent Haemothorax

Start date: January 2014
Phase: N/A
Study type: Interventional

This is a prospective, randomized study comparing VATS( Video-Assisted Thoracoscopy ) to reinsertion of a Thoracostomy Tube in patients with retained haemothorax. The hypothesis is that early VATS as opposed to reinsertion of a thoracostomy tube , will lead to less complications and shorter hospital stay.

NCT ID: NCT01862458 Withdrawn - Empyema Clinical Trials

Empyema Treated With tPA & DNAse

Start date: January 2016
Phase: Phase 3
Study type: Interventional

The objective of this study is to scientifically evaluate a new substrate for fibrinolysis compared to our standard tPA. The hypothesis, driven by a recent prospective trial, is that tPA may benefit from the addition of DNAse. The primary outcome variable between the two techniques will be length of hospitalization after initiation of treatment.

NCT ID: NCT01717742 Completed - Pleural Empyema Clinical Trials

Intrapleural DNase and Tissue Plasminogen Activator in Pediatric Empyema (DTPA Trial)

Start date: December 2012
Phase: Phase 3
Study type: Interventional

Bacterial pneumonia can be complicated by the development of excess fluid and pus (pleural empyema) around the lungs in children. The incidence of pleural empyema in children has increased significantly in the last 10 years. Short term morbidity for this condition is substantial, but unlike in adults, the long term outcome of this condition for children in developed countries is favourable. Inserting a chest drain and then adding a medicine (tissue plasminogen activator - tPA) to break down organized pus has been shown to be an effective therapy for reducing the duration of illness. However, this treatment is still suboptimal and prolonged hospitalization is common. Recent data from adults suggests that adding an additional medicine (DNase) to decrease the viscosity (thickness) of the fluid improves drainage and leads to better patient outcomes; however, there are no published studies on children. This is a multi-centre randomized controlled trial comparing the time to discharge from hospital after chest drain insertion in previously well children who present with pleural empyema, treated with intrapleural DNase and tissue plasminogen activator (tPA) by chest drain for three doses over 48 hours compared with three doses over 48 hours of tPA alone. Other outcomes related to effectiveness, safety and cost will be assessed as well.

NCT ID: NCT01625247 Recruiting - Acute Cholecystitis Clinical Trials

Drainage is Not Necessary Procedure After Laparoscopic Cholecystectomy Due to Severe Acute Cholecystitis

Start date: June 2009
Phase: Phase 3
Study type: Interventional

Laparoscopic cholecystectomy (LC) is the current preferred method of cholecystectomy. The role of routine drainage after LC to decrease postoperative morbidity is still an issue of considerable debate. The goal of this study was to assess to role of drains in LC, performed for acute inflamed gallbladder.

NCT ID: NCT01522885 Completed - Pneumothorax Clinical Trials

KatGuide Method Versus Conventional Method at Insertion of Chest Tube

KatGuide
Start date: April 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate whether if KatGuide (a new developed medical device) improves the placing of a large bore chest tube in the pleural cavity compared to the conventional method.

NCT ID: NCT01287013 Terminated - Cancer Clinical Trials

Comparing Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures

Start date: January 2011
Phase: N/A
Study type: Interventional

Background: - Procedures that use medical tools in or near a possible abnormality in the body often use computed tomography (CT) scans to locate the abnormality and guide the path that a needle will take to collect a sample of tissue. Xperguide and electromagnetic (EM) tracking are two new procedures being studied to help guide the needle. Xperguide is software that uses CT images to help the doctor choose the needle path. EM tracking uses special medical tools with miniature coils that act like a Global Positioning Satellite (GPS) device to show the location of the needle in the body. Xperguide and EM tracking have been used in humans and have good results, but they have not been compared with each other and regular CT to determine whether they are better than the standard approach. Objectives: - To compare the results of Xperguide, electromagnetic tracking, and regular computed tomography during a guided percutaneous procedure. Eligibility: - Individuals at least 18 years of age who are required to have a CT-guided percutaneous procedure. Design: - Participants will be screened with a physical examination and medical history, and the results of any previous imaging studies will be examined before study enrollment. - After a pilot phase, the study will involve two phases to compare the results of the different procedures. The first phase will involve comparing Xperguide to CT, and the second will involve comparing Xperguide to EM tracking. - Phase 1 participants will be assigned to one of two procedure groups: Group 1 will have Xperguide, and Group 2 will have regular CT. Participants who are scheduled to have repeated procedures (like a biopsy before and after chemotherapy) will be randomized for the first procedure and the second procedure will be done using the other method. - Phase 2 participants will be assigned to one of two procedure groups: Group 1 will have Xperguide, and Group 2 will have EM tracking. Participants who are scheduled to have repeated procedures (like a biopsy before and after chemotherapy) will be randomized for the first procedure and the second procedure will be done using the other method. - Standard post-procedure followup care will be given after the study procedure is completed.

NCT ID: NCT01261546 Completed - Empyema Clinical Trials

Clinical Trial Corticoids For Empyema And Pleural Effusion In Children

CORTEEC
Start date: December 2010
Phase: Phase 2
Study type: Interventional

STUDY JUSTIFICATION 1. Scientific evidence of the usefulness of corticosteroid use for infectious diseases: Corticosteroids along with antibiotic use improve survival in some infectious processes provide long term benefits and improve symptoms in many others. 2. Clinical Observation: the investigators observed that patients with parapneumonic pleural effusion and associated bronchospasm who were treated with corticosteroids for their bronchospasm, evolved to healing before patients who were not treated with corticosteroids (average admission days 10 vs. 17). 3. Rationale: the anti-inflammatory effect has been the rationale for the use of dexamethasone as an inhibitor of the inflammatory response observed after the first dose of parenteral antibiotic in bacterial meningitis. A similar effect is likely to occur in pneumonia with pleural effusion. It can be therefore hypothesized that Dexamethasone could inhibit an excessive inflammatory response by mesothelial and inflammatory cells during the early phases of parapneumonic empyema, reducing its severity and hence its complications. OBJECTIVES 1. Principal: to investigate if dexamethasone 0,25mg/kg q.i.d. added to standard antibiotic therapy reduces time to resolution of parapneumonic pleural effusion. 2. Secondary: 2.1. Evaluate the effect of dexamethasone 0,25mg/kg q.i.d. added to standard antibiotic therapy on the development of complications during pleural effusion episode. 2.2. Evaluate the incidence of severe and non severe adverse events associated with the new treatment versus standard therapy. METHODS 1. Study design: exploratory (pilot), randomized, double blinded, placebo controlled, parallel stratified design, multicentric. 2. Participating Hospitals (n=56, 7 patients per center): - Hospital Infanta Sofía (S. Sebastián de los Reyes, Madrid). - Hospital Universitario de Getafe - Hospital Universitario Ramón y Cajal, Madrid. - Hospital Universitario Materno-Infantil Carlos Haya, Málaga. - Hospital Infantil La Paz, Madrid. - Hospital U. Gregorio Marañón - Hospital U. Príncipe de Asturias - Hospital Virgen de la Salud, Toledo 3. Endpoints: 3.1. Primary: time to resolution. 3.2. Secondary endpoints: 1. Effectiveness: number of children with complications. 2. Safety (expected number: none). i) Hyperglycemia ii) Signs of gastrointestinal bleeding iii) Need of transfusion iv) Oropharyngeal Candidiasis v) Allergic reaction vi) Other adverse reactions described in the Medication Guide. 4. Treatment arms: 3.1. Control (0) - Normal saline 0,6 ml/kg, IV, q.i.d. for 2 days. - Cefotaxime 150 mg/kg, IV, q.d. until discharge criteria are present. - Ranitidine 5 mg/kg IV, q.d. for 2 days. - Amoxicillin- Clavulanic acid 80mg/kg p.o., q.d. during 15 days. 3.2. Study treatment: (1) - dexamethasone 0,25mg/kg, IV, q.i.d. for 2 days. - Cefotaxime 150 mg/kg, IV, q.d. until discharge criteria are present - Ranitidine 5 mg/kg IV, q.d. for 2 days - Amoxicillin/Clavulanic acid orally (80mg/kg/day) during 15 days. 4. INCLUSION CRITERIA - Patients between 1 and 14 year old. - Presence of pneumonia diagnosed by clinical and radiographic criteria: cough, fever and radiological consolidation. - Evidence of pleural effusion.

NCT ID: NCT01246453 Completed - Pleural Effusion Clinical Trials

Efficacy and Security of Intrapleurally Alteplase vs Urokinase for the Treatment of Complicated Parapneumonic Effusion and Empyema

Start date: December 2003
Phase: Phase 4
Study type: Interventional

1. Objectives: - Main objective: To evaluate the efficacy and safety of intrapleural alteplase vs urokinase in patients with complex complicated parapneumonic pleural effusion and empyema. - To evaluate the pleural and plasmatic levels of the fibrinolytic system markers after the treatment with alteplase vs urokinase - To evaluate the safety of alteplase in the treatment of complex complicated parapneumonic pleural effusion and empyema 2. Design: Multicentric, randomized, parallel, controlled and double blind 3. Main variable: Percentage of curation 4. Study population and number of patients: 204 patients with complex complicated parapneumonic pleural effusions and empyema 5. Duration of the treatment: Three days (main variable), and optional three days (secondary variable)

NCT ID: NCT01178580 Completed - Pneumonia Clinical Trials

Procoagulant Activity in Patients With Community Acquired Pneumonia, Pleural Effusion and Empyema

Start date: November 2010
Phase: N/A
Study type: Observational

Community acquired pneumonia (CAP) is still one of the most important causes of morbidity in adults. (1) In severe cases, parapneumonic effusions or empyema may develop. In these patients, a transitional fibrin neomatrix constitutes part of the acute inflammatory response as seen in sepsis. The aim is to study the fibrinolytic activity in patients with CAP alone versus CAP with parapneumonic effusions with and without empyema.

NCT ID: NCT01011881 Completed - Pleural Empyema Clinical Trials

Procalcitonin in Pleural Pleuritis

Start date: October 2009
Phase: N/A
Study type: Observational

The purpose of this study is to determine pleural level of procalcitonin in differents situations of pleuritis.