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Status unknownNCT03253315Updated Aug 17, 2017

Management of Pericarditis in Children.

An observational study in Pericarditis, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 12 Months to 18 Years. Per ClinicalTrials.gov, last updated 2017-08-17.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
20
Ages
12 Months to 18 Years
Sex
All
01

Study 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
Read the 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.

02

Conditions studied

  • Pericarditis

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03

Who can participate

Ages eligible
12 Months to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients who above one year of age up to 18 years diagnosed with pericarditis and/or pericardial effusions are candidates for the study.

Inclusion criteria

  • Children with pericarditis and/or pericardial effusion above one year of age detected clinically and by echocardiography

Exclusion criteria

Exclusion Criteria:

  • children below one year of age. - children with malignant effusion.
04

Study design

Observational model
Other
Time perspective
Other
Enrollment
20 participants (estimated)
Target follow-up
15 Days
Patient registry
Yes
05

What researchers measure

Primary outcomes

  1. Echocardiographic signs

    1. normal cardiac size by echocardiography (measurable by echocardiographic probe) 2. normal thickening of pericardium by echocardiography .(measurable by echocardiographic probe)

    Time frame: one month

06

Study locations

1 site
  • Assiut University
    Assiut, Egypt
07

Registry details

Key details

Study ID
NCT03253315
Lead sponsor
Assiut University
Responsible party
aya gomaa mohamed (Principal investigator, Assiut University) — Principal investigator
First posted
Aug 17, 2017
Start date
Sep 2017 (estimated)
Primary completion
Sep 2018 (estimated)
Completion
Apr 2019 (estimated)
Last update
Aug 17, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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