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

NCT ID: NCT06761872

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-25
• Study Completion Date: 2026-02-25

Brief Summary

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.

Detailed Description

• 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:

1. Demographic data (age, sex, and comorbidities).

2. 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).

3. 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.

4. 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).

5. 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.

6. 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.

Conditions

Pericardial Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Hossam Elsayed

Resident Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hossam Amgad Elsayed, resident physician

Role: CONTACT

doc.hos17@icloud.com

2001024113331

Other Identifiers

Pericardial disease in ESRD pt

Identifier Type: -

Identifier Source: org_study_id