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

NCT07338227 | Completed

• 1 other identifier: 13/3/2024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

CPE group

Patients with cardiogenic pulmonary edema

Other: Clara cell protein 16

NCPE group

Patients with non-cardiogenic pulmonary edema.

Other: Clara cell protein 16

Interventions

Clara cell protein 16 OTHER

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

CPE group; NCPE group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni Suef University

Banī Suwayf, Beni Suweif Governorate, 62511, Egypt

Location

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Beni Suef general hospital, Egypt.

Study Record Dates

• First Submitted: January 3, 2026
• First Posted: January 13, 2026
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)