Pleural Effusion Types in Chronic Kidney Disease
Starting soon
Conditions studied: Pleural Effusion, Chronic Kidney Disease
In brief
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.
Key facts
- Study ID
- NCT07547852
- Run by
- Assiut University
- People needed
- 100
- Starts
- 2026-05-01
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-04-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
- Willingness to provide written informed consent
You may not qualify if…
- 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
- Patients who refuse consent or are unable to undergo thoracentesis due to coagulopathy or other contraindications
- Pregnancy
Full record on ClinicalTrials.gov
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