Clinical trial NCT06430008: The Relationship Between Total Sialic Acid and Superoxide Dismutase and the Diagnosis and Prognosis of Lipoid Pneumonia
Official title: A Study to Explore the Correlation Between Total Sialic Acid Combined With Superoxide Dismutase and the Diagnosis and Prognosis of Lipoid Pneumonia
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Lipid Pneumonia
Superoxide Dismutase
Sialic Acid
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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\&lt; 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

Primary outcomes:
measure: superoxide dismutase
timeFrame: At the time of admission
Secondary outcomes:
measure: sialic acid
timeFrame: At the time of admission
measure: death or not
timeFrame: Within 10 years after discharge
measure: neutrophil-to-lymphocyte ratio
timeFrame: At the time of admission
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Yinan Hu
role: STUDY_CHAIR
References: