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NCT Number: NCT06761872

Predisposing Factors and Prevalence of Pericardial Diseases Among ESRD Patients Who Are Admitted in Critical Care Medicine Unit in Assuit University Hospital

The main objectives of this observational study are:

1. Provide reliable data on the prevalence of pericardial diseases, pericardial effusion, constrictive pericarditis and its predisposing factors among ESRD patients, undergoing long-term dialysis. 2. Detect the predisposing factors that could contribute to pericardial effusion amount and severity.

Participants (or their designated contact persons) will be contacted over the phone for either a telephone interview or a follow-up visit in the outpatient clinics, whatever feasible and possible.

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Key information

Conditions

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

  • Inclusion Criteria: Patients with ESRD with a GFR <10 cc/min admitted to the internal medicine department nephrology unit or undergoing regular hemodialysis.
  • Exclusion Criteria: Patients presented with non-uremic pericarditis such as intra-thoracic malignancy, injury (thoracic, oesophageal, and iatrogenic trauma), pulmonary TB, autoimmune diseases, history suggestive of recent viral infection, myxedema, and severe HF.
  • Study tools:
  • Demographic data (age, sex, and comorbidities).
  • Clinical data including (The etiology of ESRD). (History of stitching anterior chest pain worse on inspiration, audible friction rub, and raised JVP).

(Muffled heart sounds, ascites, and lower limb edema).

  • ECG for signs of pericarditis, such as concave ST segment elevation in all leads, and signs of tamponade, such as low-voltage complexes with electrical alternates.
  • Doppler echocardiography by Phillips HD 11: for detection of amount and severity of pericardial effusion. The severity was defined as Small (10 < mm echo-free space behind the left ventricle). Moderate (10-20 mm, echo-free space behind the left ventricle and in front of the right ventricle in less than 1 cm).

Large (>20 mm which was the mentioned finding in addition to a right-sided atrial collapse).

  • Echocardiography in constrictive pericarditis shows the presence of small left ventricular dimensions with preserved systolic function, impaired diastolic function, dilated atria, abrupt termination of diastolic filling, interventricular septal bounce expiratory diastolic flow reversal in hepatic veins and tissue doppler of the medial mitral annulus is more than lateral.
  • Serum calcium and phosphorus concentrations and creatinine levels in both serum and urine were elevated. Serum lipid profile, serum albumin, hormone tests such as thyroid and parathyroid along with complete blood count.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with ESRD with a GFR <10 cc/min are admitted to the internal medicine department nephrology unit or undergoing regular hemodialysis.

Exclusion criteria

  • Patients presented with non-uremic pericarditis such as intra-thoracic malignancy, injury (thoracic, oesophageal, and iatrogenic trauma), pulmonary TB, autoimmune diseases, history suggestive of recent viral infection, myxedema, and severe HF.

Treatment and study plan

Primary outcomes

  1. Detection of variable pericardial diseases in patients with ESRD.

    Time frame: 1 year

    variable pericardial diseases in patients with ESRD.

Secondary outcomes

  1. Detection of predisposing factors of pericardial effusion.

    Time frame: 1 year

    predisposing factors of pericardial effusion.

Study contacts

Contact information is provided by the study sponsor or research team.

Hossam Amgad Elsayed, resident physician

CONTACT

[email protected]

2001024113331

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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