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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05914428
• Other study ID #: 2020BIPROSALDH2
• Status: Recruiting
• Start date: June 13, 2023
• Est. completion date: July 15, 2023

Study information

• Verified date: June 2023
• Source: Qilu Hospital of Shandong University
• Contact: Jiaojiao Pang, Dr
• Phone: 18560089129
• Email: jiaojiaopang[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: July 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Sepsis
• Toxemia

Intervention

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

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Progression to ARDS within 7 days (Berlin criteria)	The proportion of patients with sepsis progressing to ARDS	From ICU administration to days 7
Secondary	Mechanical ventilation days	Days of mechanical ventilation from study drug administration to discharge of ICU	From administration to discharge hospital, up to 90 days
Secondary	Length of hospital stay	The number of days the subject stayed in the hospital	From administration to discharge hospital, up to 90 days
Secondary	Length of ICU stay	The number of days the subject stayed in the ICU	From administration to discharge ICU, up to 90 days
Secondary	incidence of septic shock	incidence of septic shock	From administration to discharge ICU, up to 90 days