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

Sponsor
Qilu Hospital of Shandong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05914428
Collaborator
(none)
170
1
1.1
161.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: ALDH2 rs671 mutation

Study Design

Study Type:
Observational
Anticipated Enrollment :
170 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Biomarkers to Predict Acute Respiratory Distress Syndrome(ARDS) in Patients With Sepsis
Actual Study Start Date :
Jun 13, 2023
Anticipated Primary Completion Date :
Jul 15, 2023
Anticipated Study Completion Date :
Jul 15, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  1. Mechanical ventilation days [From administration to discharge hospital, up to 90 days]

    Days of mechanical ventilation from study drug administration to discharge of ICU

  2. Length of hospital stay [From administration to discharge hospital, up to 90 days]

    The number of days the subject stayed in the hospital

  3. Length of ICU stay [From administration to discharge ICU, up to 90 days]

    The number of days the subject stayed in the ICU

  4. incidence of septic shock [From administration to discharge ICU, up to 90 days]

    incidence of septic shock

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Qilu Hospital of Shandong University Jinan China

Sponsors and Collaborators

  • Qilu Hospital of Shandong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier:
NCT05914428
Other Study ID Numbers:
  • 2020BIPROSALDH2
First Posted:
Jun 22, 2023
Last Update Posted:
Jun 22, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Qilu Hospital of Shandong University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2023