About this trial
The purpose of this observational study is to understand the causes of pleural effusion (a buildup of fluid around the lungs) in patients with advanced Chronic Kidney Disease (CKD Stages 3 to 5). Pleural effusion is a common complication in kidney disease, but it can be caused by many different issues, such as simple fluid overload, heart failure, or infections like tuberculosis.
To treat this fluid buildup effectively, doctors need to classify whether the fluid is a transudate (usually caused by pressure imbalances like fluid overload) or an exudate (caused by inflammation, lung disease, or infection). Standard medical formulas, known as Light's Criteria, are typically used to figure this out by comparing proteins in the fluid to proteins in the blood. However, these standard tests may sometimes misclassify the fluid in kidney disease patients because their baseline blood protein and albumin levels are often altered by their condition.
Researchers in this study will enroll adult CKD patients (both on dialysis and not yet on dialysis) who have confirmed fluid around their lungs. Participants will undergo a standard, ultrasound-guided procedure called a diagnostic thoracentesis to safely draw a small amount of the chest fluid. At the same time, a routine blood sample will be taken.
The study aims to:
* Compare the chest fluid to the blood sample using standard criteria, abbreviated criteria, and the Serum-Pleural Effusion Albumin Gradient (SPAG). * Determine the most common underlying causes of lung fluid across different stages of kidney disease. * Identify which diagnostic formula is the most accurate for CKD patients, helping doctors avoid misdiagnosis and provide better, more targeted treatments.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged ≥18 years of either sex
Confirmed diagnosis of CKD Stage 3-5 based on eGFR < 60 mL/min/1.73 m² for ≥3 months, as per KDIGO 2012 guidelines
Radiologically confirmed pleural effusion on chest X-ray (CXR) or thoracic ultrasound
Patients on hemodialysis or peritoneal dialysis, as well as those not yet on dialysis (CKD Stage 3-5 pre-dialysis)
Disqualifiers
Patients with Acute Kidney Injury (AKI) or acute-on-chronic kidney disease without prior CKD diagnosis
Trauma-related pleural effusion (hemothorax, chylothorax)
Known active malignancy with suspected malignant effusion
Patients with post-surgical or iatrogenic pleural effusion
Trial population
The study population comprises adult patients (≥18 years) with a confirmed diagnosis of Chronic Kidney Disease (CKD) Stages 3, 4, or 5 (eGFR \< 60 mL/min/1.73 m² for ≥3 months) who present with a radiologically confirmed pleural effusion. The cohort includes both pre-dialysis patients and those currently on maintenance hemodialysis or peritoneal dialysis. Participants will be enrolled from Assiut University Hospitals. Patients with acute kidney injury, trauma-related effusions, active malignancies, post-surgical effusions, or those who are pregnant are excluded from the sample.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Number of Participants Classified with Transudative or Exudative Pleural Effusions
The primary outcome assesses the number of participants whose pleural effusion is classified as either transudative or exudative. This classification is determined by applying Standard Light's Criteria to pleural fluid and simultaneous serum laboratory tests. An effusion is defined as exudative if any one of the following is met: pleural fluid/serum protein ratio \> 0.5 , pleural fluid/serum LDH ratio \> 0.6 , or pleural fluid LDH \> 2/3 of the upper normal limit of serum LDH. If none are met, it is classified as transudative.
Locations
Sponsors and contacts
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