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

NCT ID: NCT07338227

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-01-01

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CPE group

Patients with cardiogenic pulmonary edema

Clara cell protein 16

Intervention Type: OTHER

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

NCPE group

Patients with non-cardiogenic pulmonary edema.

Clara cell protein 16

Intervention Type: OTHER

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

Interventions

Clara cell protein 16

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patients aged 18 years or older.
• Both sexes.
• Patients requiring intensive care unit (ICU) admission and intubation.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Amr Ahmed Foad Ali

Beni Suef general hospital, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beni Suef University

Banī Suwayf, Beni Suweif Governorate, Egypt

Countries

Egypt

Other Identifiers

13/3/2024

Identifier Type: -

Identifier Source: org_study_id