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).

Study Overview

• Status: Completed
• Conditions: Cardiogenic Pulmonary Edema; Differentiation; Diagnostic Biomarker; Clara Cell Protein; Non-Cardiogenic Pulmonary Edema
• Intervention / Treatment: Other: Clara cell protein 16

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Egypt
  • Beni Suweif Governorate
    • Banī Suwayf, Beni Suweif Governorate, Egypt, 62511
      • Beni suef university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study employed a prospective observational design to evaluate 100 patients receiving intubation, mechanical ventilation, and admission to the critical care department at Beni-Suef General Hospital between January 2023 and January 2024 for cardiogenic or non-cardiogenic pulmonary edema. Ethical approval was obtained from Cairo University's Faculty of Medicine.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CPE group; Patients with cardiogenic pulmonary edema	Other: Clara cell protein 16; 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.	Other: Clara cell protein 16; Clara cell protein 16 (CC16) concentration was measured in serum samples drawn within 24 hours of intubation.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: January 3, 2026
• First Submitted That Met QC Criteria: January 3, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 3, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Injury; Acute Lung Injury
• Other Study ID Numbers: 13/3/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No