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

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis
• Intervention / Treatment: Other: ALDH2 rs671 mutation

• Study Type: Observational
• Enrollment (Estimated): 170

Contacts and Locations

• Study Contact: Name: Jiaojiao Pang, Dr; Phone Number: 18560089129; Email: jiaojiaopang@126.com

Study Locations

• China
  • Jinan, China
    • Recruiting
    • Qilu Hospital of Shandong University
    • Contact: Jiaojiao Pang; Phone Number: 18560089129; Email: jiaojiaopang@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

We conducted a single-centre, retrospective cohort study of patients diagnosed with sepsis, consecutively admitted to the intensive care unit of Qilu Hospital,Shandong university during 2020.9-2022.3,except for holidays.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
sepsis; 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; 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

What is the study measuring?

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
Length of hospital stay	The number of days the subject stayed in the hospital	From administration to discharge hospital, up to 90 days
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 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

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2023
• Primary Completion (Estimated): July 15, 2023
• Study Completion (Estimated): July 15, 2023

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: ARDS; sepsis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Sepsis; Toxemia; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 2020BIPROSALDH2

Drug and device information, study documents

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