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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07338227

Enrollment

100

Registered

2026-01-13

Start date

2023-01-01

Completion date

2024-01-01

Last updated

2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiogenic Pulmonary Edema, Clara Cell Protein, Diagnostic Biomarker, Differentiation, Non-Cardiogenic Pulmonary Edema

Brief summary

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).

Detailed description

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.

Interventions

OTHERClara cell protein 16

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026