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

Sponsor

Meir Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01178580

Collaborator

(none)

Enrollment

Location

Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim is to study the fibrinolytic activity in patients with CAP alone versus CAP with parapneumonic effusions with and without empyema.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia Pleural Effusion Empyema

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

75 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.