Clinical trial NCT06761872: Predisposing Factors and Prevalence of Pericardial Diseases Among ESRD Patients Who Are Admitted in Critical Care Medicine Unit in Assuit University Hospital
Official title: Predisposing Factors and Prevalence of Pericardial Diseases Among ESRD Patients Who Are Admitted in Critical Care Medicine Unit in Assuit University Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pericardial Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

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.

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.

Primary outcomes:
measure: Detection of variable pericardial diseases in patients with ESRD.
timeFrame: 1 year
Secondary outcomes:
measure: Detection of predisposing factors of pericardial effusion.
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References: