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Completed

NCT Number: NCT07338227

Validation of Clara Cell Protein as a Novel Diagnostic Biomarker for the Differentiation of Cardiogenic Pulmonary Edema From Non-Cardiogenic Pulmonary Edema

This study aimed to validate the use of clara cell secretory protein (CC16) as a biomarker for differentiating between cardiogenic pulmonary edema (CPE) and non-cardiogenic pulmonary edema (NCPE).

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beni Suef University

Banī Suwayf, Beni Suweif Governorate, 62511, Egypt

About this study

Club cells or Clara cells (CCs) were first described in 1881 but their importance was forgotten until Max Clara's 1937 study identifying these bronchiolar exocrine cells. CCs constitute up to 44% of proliferating small airway cells, functioning as epithelial progenitors during lung regeneration and repair of injury.

CC16 can be useful in distinguishing between cardiogenic pulmonary edema (CPE), caused by increased pressure in the heart's left ventricle, and non-cardiogenic pulmonary edema, such as acute lung injury (ALI) or acute respiratory distress syndrome (ARDS), which are not related to heart failure. Patients with ALI/ARDS tend to have lower levels of CC16 in their plasma and pulmonary edema fluid compared to those with CPE, suggesting a potential diagnostic role for CC16 in these conditions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients aged 18 years or older.
  • Both sexes.
  • Patients requiring intensive care unit (ICU) admission and intubation.
  • Inclusion criteria followed the American-European Consensus Conference diagnostic guidelines for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS): acute respiratory failure onset, bilateral infiltrates on chest radiography, a PaO2/FiO2 ratio below 300 for ALI or 200 for ARDS and no evidence of left atrial hypertension

Exclusion criteria

  • Critically ill but not intubated.
  • Had a mixed cause of pulmonary edema like pneumonia with heart failure.

Treatment and study plan

Clara cell protein 16

Other

Clara cell protein 16 (CC16) concentration was measured in serum samples drawn within 24 hours of intubation.

Primary outcomes

  1. Clara cell secretory protein (CC16) level

    Time frame: Within 24 hours of intubation

    Clara cell secretory protein (CC16) level was measured in serum samples drawn within 24 hours of intubation.

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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