The Relationship Between Total Sialic Acid and Superoxide Dismutase and the Diagnosis and Prognosis of Lipoid Pneumonia

A Study to Explore the Correlation Between Total Sialic Acid Combined With Superoxide Dismutase and the Diagnosis and Prognosis of Lipoid Pneumonia

The goal of this observational study is to explore the correlation between total sialic acid combined with superoxide dismutase and the diagnosis and prognosis of lipid pneumonia in the patient with lipid pneumonia, cough, bacterial and fungal pneumonia, cryptogenic organizing pneumonia, pulmonary alveolar proteinosis, lung mucinous adenocarcinoma and pulmonary edema. The main question it aims to answer is:

Whether superoxide dismutase (SOD) and total sialic acid (TSA) could be used as diagnostic markers to distinguish lipid pneumonia from patient with cough, and bacterial and fungal pneumonia, cryptogenic organizing pneumonia, pulmonary alveolar proteinosis, lung mucinous adenocarcinoma and pulmonary edema, whether SOD and TSA be associated with the prognosis of patients with lipid pneumonia?

Participants will answer online survey questions about their symptoms, changes in oxygen status, and changes in the most recent CT image of the lung for up to 10 years after treatment. We will count participants' baseline data including: gender, age, smoking history, comorbidities, lung function, imaging findings, hormone use or not, ICU treatment, death or not, the type of cause of lipid pneumonia, how it is diagnosed, and their baseline SOD and TSA.

Study Overview

• Status: Enrolling by invitation
• Conditions: Sialic Acid; Superoxide Dismutase; Lipid Pneumonia

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

This study includes the lipoid pneumonia patients, patients with cough in the upper respiratory tract only, patients with bacterial and fungal pneumonia, patients with cryptogenic organizing pneumonia and pulmonary alveolar proteinosis, patients with lung mucinous adenocarcinoma and patients with pulmonary edema.

Description

Inclusion Criteria:

1. Age≥ 18 years old;
2. The diagnosis of lipoid pneumonia must be supported by lung biopsy pathological support or positive oil red O or Sudan staining in bronchoalveolar lavage fluid;
3. Patients with bacterial and fungal pneumonia must be supported by etiological evidence;
4. Patients with cryptogenic organizing pneumonia and pulmonary alveolar proteinosis must be supported by lung biopsy pathology;
5. Patients with lung mucinous adenocarcinoma must be supported by lung tissue biopsy;
6. Lung imaging of patients with pulmonary edema must show paving stone signs;

Exclusion Criteria:

1. Age< 18 years old;
2. The patient only has a history of lipid inhalation and no pathology or positive lipoid staining;
3. Co-infection with the corona virus disease 2019 at the onset of illness;
4. Pregnant

Study Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort
lipid pneumonia
cough
cryptogenic organizing pneumonia
pulmonary alveolar proteinosis
bacterial pneumonia
fungal pneumonia
pulmonary edema
mucinous adenocarcinoma of the lung

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
superoxide dismutase	At the time of admission

Secondary Outcome Measures

Outcome Measure	Time Frame
sialic acid	At the time of admission
death or not	Within 10 years after discharge
neutrophil-to-lymphocyte ratio	At the time of admission

Collaborators and Investigators

• Sponsor: Hu Yinan
• Investigators: Study Chair: Yinan Hu, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Aspiration; Pneumonia; Pneumonia, Lipid
• Other Study ID Numbers: 2024-KY-144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD collected throughout the trial, only IPD used in the results publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

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