Management of Pericarditis in Children.

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03253315
Collaborator
(none)
20
1
19
1.1

Study Details

Study Description

Brief Summary

The pericardium is a double-walled sac containing the heart and the roots of the great vessels. The pericardial sac has two layers, a serous visceral l layer (also known as epicardium when it comes into contact with the myocardium) and a fibrous parietal layer. It encloses the pericardial cavity, which contains pericardial fluid. The pericardium fixes the heart to the mediastinum, gives protection against infection and provides lubrication for the heart. Pericardial diseases may be either isolated disease or part of a systemic disease Diseases of the pericardium present clinically in one of several ways

  • Acute and recurrent pericarditis

  • Pericardial effusion without major hemodynamic compromise

  • Cardiac tamponade with cardiac compromise

  • Constrictive pericarditis

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    • Pericarditis usually present with chest pain and dyspnea. Effusion can present with no symptoms, dull ache in left chest and abdominal pain Cardiac tamponade is recognized by the excessive fall of systolic blood pressure

    • Diagnostic workup A) Chest X-ray:_ chest X-ray can detect varying degree of cardiomegaly. B) Echocardiography: It is the first-line imaging test. clinically, two-dimensional echocardiography with Doppler provides the most cost-effective way of diagnosing C) Electrocardiograph D) cardiac computerized tomography :- Also may be helpful 4)Therapy of pericarditis in pediatrics the medical lines of treatment of pericarditis are:_ A)Aspirin and non-steroidal anti-inflammatory:_ are the mainstay of the therapy of inflammatory pericardial diseases B)Steroids: a minority of patients will require treatment with systemic steroid therapy as

    • Patients with symptoms refractory to standard therapy

    • Acute pericarditis due to connective tissue disease ●Uremic pericarditis C)Immunosuppressant and biological drugs (more commonly used in recurrent pericarditis) .Interventional therapeutic techniques-_

    Most patients with acute pericarditis can be managed effectively with medical therapy alone.

    However, patients may require invasive therapies for:
    • A moderate to large pericardial effusion, particularly if hemodynamically significant.

    • Frequent, highly symptomatic recurrences of acute pericarditis with pericardial effusion ●Evidence of constrictive pericarditis (a late occurrence when present) A)Pericardial drainage :Prolonged catheter drainage of a pericardial effusion is an effective means of preventing fluid reaccumulation.

    B)Pericardiotomy, pericardial window and pericardiectomy: pericardiectomy may be considered for frequent and highly symptomatic recurrences of pericarditis tamponade .. C)Surgical decompression of the pericardium :_can be achieved either by conventional heart surgery or video-assisted thoracoscopy.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    Clinical Audit of the Management of Pericarditis in Children.
    Anticipated Study Start Date :
    Sep 1, 2017
    Anticipated Primary Completion Date :
    Sep 1, 2018
    Anticipated Study Completion Date :
    Apr 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Echocardiographic signs [one month]

      normal cardiac size by echocardiography (measurable by echocardiographic probe) normal thickening of pericardium by echocardiography .(measurable by echocardiographic probe)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Months to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Children with pericarditis and/or pericardial effusion above one year of age detected clinically and by echocardiography
    Exclusion Criteria:
    • children below one year of age. - children with malignant effusion.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut University Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    aya gomaa mohamed, Principal investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03253315
    Other Study ID Numbers:
    • ayafadl24791
    First Posted:
    Aug 17, 2017
    Last Update Posted:
    Aug 17, 2017
    Last Verified:
    Aug 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 17, 2017