Clinical trial NCT05914428: Biomarkers to Predict Acute Respiratory Distress Syndrome(ARDS) in Patients With Sepsis
Official title: Biomarkers to Predict Acute Respiratory Distress Syndrome(ARDS) in Patients With Sepsis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Keywords: sepsis
ARDS
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Temporal dynamics of PaO2/FiO2
timeFrame: From ICU administration to days 7
measure: Progression to ARDS within 7 days (Berlin criteria)
timeFrame: From ICU administration to days 7
Secondary outcomes:
measure: Mechanical ventilation days
timeFrame: From administration to discharge hospital, up to 90 days
measure: Length of hospital stay
timeFrame: From administration to discharge hospital, up to 90 days
measure: Length of ICU stay
timeFrame: From administration to discharge ICU, up to 90 days
measure: incidence of septic shock
timeFrame: From administration to discharge ICU, up to 90 days
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
Study officials:
References: