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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05914428
Enrollment
170
Registered
2023-06-22
Start date
2023-06-13
Completion date
2023-07-15
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

sepsis, ARDS

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.

Interventions

OTHERALDH2 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

Sponsors

Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Temporal dynamics of PaO2/FiO2From ICU administration to days 7PaO2/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 7The proportion of patients with sepsis progressing to ARDS

Secondary

MeasureTime frameDescription
incidence of septic shockFrom administration to discharge ICU, up to 90 daysincidence of septic shock
Length of hospital stayFrom administration to discharge hospital, up to 90 daysThe number of days the subject stayed in the hospital
Length of ICU stayFrom administration to discharge ICU, up to 90 daysThe number of days the subject stayed in the ICU
Mechanical ventilation daysFrom administration to discharge hospital, up to 90 daysDays of mechanical ventilation from study drug administration to discharge of ICU

Countries

China

Contacts

Primary ContactJiaojiao Pang, Dr
jiaojiaopang@126.com18560089129

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026