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

NCT05914428 | Unknown

• 1 other identifier: 2020BIPROSALDH2
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

sepsis; ARDS

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Mechanical ventilation days

  From administration to discharge hospital, up to 90 days

• Length of hospital stay

  From administration to discharge hospital, up to 90 days

• Length of ICU stay

  From administration to discharge ICU, up to 90 days

• incidence of septic shock

  From administration to discharge ICU, up to 90 days

Study Arms (1)

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

Interventions

ALDH2 rs671 mutation OTHER

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

sepsis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, China

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jiaojiao Pang, Dr

CONTACT

18560089129; jiaojiaopang@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: June 13, 2023
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

CN (1)