Identifying biomarkers for predicting ARDS in sepsis patients

Biomarkers to Predict Acute Respiratory Distress Syndrome(ARDS) in Patients With Sepsis

This study is trying to see if a specific gene mutation can help predict which sepsis patients are at risk of developing serious breathing problems called ARDS.

Quick facts

• Study type: Observational
• Enrollment: 170 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Qilu Hospital of Shandong University (Academic / other)
• Locations: 1 site (Jinan)
• Trial ID: NCT05914428 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the role of the ALDH2 rs671 mutation in predicting the development of acute respiratory distress syndrome (ARDS) in patients diagnosed with sepsis. By analyzing patients admitted to the ICU with sepsis, the study seeks to identify biomarkers that could help in understanding the risk of ARDS, which is a severe complication associated with high mortality rates. The study focuses on the relationship between the ALDH2 enzyme and the inflammatory processes involved in septic ARDS. The findings could lead to better-targeted therapies and improved patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are ICU patients aged 18 to 85 years who have been diagnosed with sepsis.

Not a fit: Patients with pre-existing lung diseases, nerve injuries requiring prolonged ventilation, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved prediction and management of ARDS in sepsis patients, potentially reducing mortality rates.

How similar studies have performed: While the specific approach of using ALDH2 as a biomarker in this context may be novel, previous studies have explored biomarkers in ARDS and sepsis with varying degrees of success.

Eligibility criteria

Inclusion Criteria:

Patients admitted to the ICU who were aged 18 to 85 years with a diagnosis of sepsis.Sepsis was assessed according to the third international consensus definition as life-threatening organ dysfunction caused by a dysregulated host response to infection; organ dysfunction was defined as an acute change in total Sequential Organ Failure Assessment (SOFA) score of ≥2 points consequent to the infection.

Exclusion Criteria:

1. interstitial lung disease, chronic obstructive pulmonary disease or congestive heart failure;
2. nerve injury or disease with likely prolonged ventilation；
3. the use of long-term oxygen therapy or noninvasive ventilation at home;
4. pregnancy or breastfeeding.

Where this trial is running

Jinan

• Qilu Hospital of Shandong University — Jinan, China (Recruiting)

Study contacts

• Study coordinator: Jiaojiao Pang, Dr

Conditions Sepsis; sepsis; ARDS