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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01178580
First received: August 8, 2010
Last updated: September 5, 2011
Last verified: September 2011
  Purpose

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.


Condition
Pneumonia
Pleural Effusion
Empyema

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Procoagulant Activity in Patients With Community Acquired Pneumonia, Pleural Effusion and Empyema

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Enrollment: 75
Study Start Date: November 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01178580

Locations
Israel
Pulmonary department, Meir Medical Center
Kfar Saba, Israel, 49100
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: David Shitrit, MD Meir Medical Center
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01178580     History of Changes
Other Study ID Numbers: MMC10-138-10.CTIL
Study First Received: August 8, 2010
Last Updated: September 5, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by Meir Medical Center:
fibrinolytic activity
Community acquired pneumonia (CAP)
Pleural effusion

Additional relevant MeSH terms:
Empyema
Pleural Effusion
Pneumonia
Infection
Inflammation
Lung Diseases
Pathologic Processes
Pleural Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Suppuration

ClinicalTrials.gov processed this record on October 21, 2014