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

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01178580
• Other study ID #: MMC10-138-10.CTIL
• Status: Completed
• Phase: N/A
• First received: August 8, 2010
• Last updated: September 5, 2011
• Start date: November 2010
• Est. completion date: August 2011

Study information

• Verified date: September 2011
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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.

Description:

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. (2) The increased vascular permeability, mediated by several cytokines, such as IL-1, IL-6, IL-8, tumor necrosis factor (TNF), and platelet activator factor, allows migration of inflammatory cells, an increased fluid accumulation and bacterial invasion into pleural space. (3) At this stage, activation of the coagulation cascade leads to procoagulant activity and decreased fibrinolysis with deposition of fibrin in the pleural space. The activation of the fibrinolytic system produce the D-dimer and follow by increased other procoagulant markers like thrombin anti thrombin, fragment 1.2 (4-5) Several studies showed that the plasma D-dimer levels were increased even in community-acquired pneumonia patients. Moreover, others reported that Serum levels of AT-III, D-D and CRP at admission appear to be useful biomarkers for assessing the severity of CAP. However, no data exists about the fibrinolytic profile in patients with CAP alone in compare to CAP with parapneumonic effusion with and without empyema.

Aim:

To study the fibrinolytic activity in patients with CAP alone versus CAP with parapneumonic effusions with and without empyema.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients that will be admitted with CAP to the pulmonary department in Meir Medical Center and have no exclusion criteria will be included in the study.

Exclusion Criteria:

• Patients younger than 18 years old

• Patients with anticoagulant treatment, primary coagulopathy, nephrotic syndrome, surgery, other infection in the month preceding the study, an abnormal liver or renal function test(s), a history of deep vein thrombosis in the last year or patients with acute coronary syndrome.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Empyema
• Pleural Effusion
• Pneumonia

Locations

Country	Name	City	State
Israel	Pulmonary department, Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel,