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

Study Overview
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Brief Summary
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Sepsis-induced acute respiratory distress syndrome (ARDS) is a life-threatening acute inflammatory lung injury, associated with increased pulmonary microvascular permeability, increased lung weight, and loss of aerated lung tissue.Despite advances in critical care, no established and targeted treatment for ARDS, contributing to a persistently high mortality rate of 34% to 45%. Therefore, exploring novel therapeutic targets for septic ARDS is of paramount importance.Acetaldehyde dehydrogenase 2 (ALDH2) is a mitochondrial enzyme that serves as the primary toxic aldehyde scavenger and is expressed in various cells, including neutrophils. The ALDH2 rs671 single nucleotide polymorphism, leading to an approximate 90% decrease in ALDH2 enzymatic activity, is implicated in occurrence of macrovascular conditions, such as coronary artery disease, pulmonary arterial hypertension, and aortic aneurysm or dissection.An array of studies has delved into role of ALDH2 in regulating cellular processes, including inflammation, autophagy, apoptosis, necrosis,efferocytosis and pyroptosis.but whether it associated with the incidence of septic-ARDS remains unknown.The aim of this study was to determine whether the ALDH2 rs671 single nucleotide polymorphism was associated with the incidence of septic-ARDS.

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

Conditions
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Sepsis

Intervention / Treatment
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* Other: ALDH2 rs671 mutation


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| sepsis<br>We selected blood samples from sepsis patients from the biological bank of Qilu hospital.The ALDH2 genotype (rs671) was detected in these septic patients and divided into ALDH2 wild-type ,ALDH2 rs671 mutation. | Other: ALDH2 rs671 mutation<br>* We selected blood samples from sepsis patients from the biological bank of Qilu hospital and tested their genotypes. The intervention group was ALDH2 rs671 mutation patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temporal dynamics of PaO2/FiO2 | PaO2/FiO2 or SpO2 / FiO2 was recorded on ICU admission，day 1 and 7 | From ICU administration to days 7 | 
| Progression to ARDS within 7 days (Berlin criteria) | The proportion of patients with sepsis progressing to ARDS | From ICU administration to days 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical ventilation days | Days of mechanical ventilation from study drug administration to discharge of ICU | From administration to discharge hospital, up to 90 days | 
| Length of hospital stay | The number of days the subject stayed in the hospital | From administration to discharge hospital, up to 90 days | 
| Length of ICU stay | The number of days the subject stayed in the ICU | From administration to discharge ICU, up to 90 days | 
| incidence of septic shock | incidence of septic shock | From administration to discharge ICU, up to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, ARDS