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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pericardial Disease

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Hossam Amgad Elsayed, resident physician; Phone Number: 2001024113331; Email: doc.hos17@icloud.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of variable pericardial diseases in patients with ESRD.	variable pericardial diseases in patients with ESRD.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of predisposing factors of pericardial effusion.	predisposing factors of pericardial effusion.	1 year

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): February 25, 2025
• Primary Completion (Estimated): April 25, 2025
• Study Completion (Estimated): February 25, 2026

Study Registration Dates

• First Submitted: December 31, 2024
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Pericardial disease in ESRD pt

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No