Pleural Effusion Types in Chronic Kidney Disease

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: CKD Stage 3-5 with Pleural Effusion

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (at the time of diagnostic thoracentesis)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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