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

Beni-Suef University

Status: Completed

Conditions: Non-Cardiogenic Pulmonary Edema; Diagnostic Biomarker; Clara Cell Protein; Differentiation; Cardiogenic Pulmonary Edema

Treatments: Other: Clara cell protein 16

Study type: Observational

Funder types: Other

Identifiers

NCT07338227

13/3/2024

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

100 participants in 2 patient groups

CPE group

Description:

Patients with cardiogenic pulmonary edema

Treatment:

Other: Clara cell protein 16

NCPE group

Description:

Patients with non-cardiogenic pulmonary edema.

Treatment:

Other: Clara cell protein 16