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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:
Chronic kidney disease (CKD) is a major global health burden. As CKD progresses through stages III-V, systemic complications become increasingly prevalent, with pleural effusion identified in 20-40% of CKD patients at autopsy. Pleural effusion in CKD arises from diverse mechanisms. Transudative effusions are predominantly associated with fluid overload and heart failure. Exudative effusions are most commonly caused by tuberculosis, uremic pleuritis, and parapneumonic processes.
The cornerstone of differentiating transudative from exudative pleural effusions remains Light's Criteria. However, the criteria carry an acknowledged risk of misclassification in CKD patients, where altered protein metabolism, reduced serum albumin, and dialysis-related biochemical shifts may distort pleural fluid-serum ratios. Given the diagnostic complexity posed by coexisting comorbidities, there is a clear need for a dedicated prospective study that systematically evaluates the incidence, etiology, and biochemical classification of pleural effusions in CKD Stage 3-5 patients.
Eligible participants will undergo a comprehensive clinical evaluation, which includes a structured clinical history form to capture demographic data, presenting symptoms, CKD history, dialysis status, and comorbidities. A physical examination will assess signs of fluid overload and pleural effusion findings.
Imaging studies will be utilized to confirm and grade the effusion. This includes a Chest X-ray (PA view) as an initial screening tool and Thoracic Ultrasound to assess effusion volume, echogenicity, and loculation. A CT Chest may be performed if ultrasound or X-ray findings are inconclusive, or if malignancy or complicated effusion is suspected.
A diagnostic thoracentesis will be performed under full aseptic conditions and ultrasound guidance to minimize complications. Approximately 30-60 mL of pleural fluid will be aspirated for diagnostic analysis, which includes gross appearance, total protein, LDH, glucose, pH, albumin, cell count, Gram stain, AFB smear, and cytology. Simultaneous serum laboratory tests will be collected at the same time as the thoracentesis for ratio calculations.
To evaluate diagnostic accuracy in the CKD population, four classification methods will be applied to each patient's samples:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD Stage 3-5 with Pleural Effusion | Adult patients (≥18 years old) with a confirmed diagnosis of Chronic Kidney Disease (CKD) Stages 3 through 5, including both pre-dialysis and dialysis-dependent patients, who present with a radiologically confirmed pleural effusion. Patients in this cohort will undergo an ultrasound-guided diagnostic thoracentesis alongside simultaneous serum laboratory testing. The collected pleural fluid and serum will be analyzed to classify the effusion (using Light's Criteria, abbreviated criteria, and SPAG) and to determine its underlying etiology. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (at the time of diagnostic thoracentesis) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| ID | Term |
|---|---|
| D010996 | Pleural Effusion |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |