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

Recruiting

• Conditions: Sepsis
• Interventions: Other: ALDH2 rs671 mutation

• Registration Number: NCT05914428
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study Start: 2023-06-13
• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2023-06-13
• Last Update Submitted: 2023-06-13
• Study First Posted: 2023-06-22
• Last Update Posted: 2023-06-22
• Primary Completion: 2023-07-15
• Study Completion: 2023-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
sepsis	ALDH2 rs671 mutation	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
incidence of septic shock	From administration to discharge ICU, up to 90 days	incidence of septic shock
Length of hospital stay	From administration to discharge hospital, up to 90 days	The number of days the subject stayed in the hospital
Length of ICU stay	From administration to discharge ICU, up to 90 days	The number of days the subject stayed in the ICU
Mechanical ventilation days	From administration to discharge hospital, up to 90 days	Days of mechanical ventilation from study drug administration to discharge of ICU

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, China