SepsisNCT05914428
Biomarkers to Predict Acute Respiratory Distress Syndrome(ARDS) in Patients With Sepsis
An observational study of Sepsis, run by Qilu Hospital of Shandong University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sepsis
- What is being tested?
- ALDH2 rs671 mutation
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2023to 15 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan
Jiaojiao Pang, 18560089129, jiaojiaopang@126.com
About this study
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
- Being tested
- ALDH2 rs671 mutation
- Keywords
- sepsis, ARDS
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALDH2 rs671 mutationOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: ALDH2 rs671 mutation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporal dynamics of PaO2/FiO2
PaO2/FiO2 or SpO2 / FiO2 was recorded on ICU admission，day 1 and 7
Measured: From ICU administration to days 7
Progression to ARDS within 7 days (Berlin criteria)
The proportion of patients with sepsis progressing to ARDS
Measured: From ICU administration to days 7
Secondary outcomes (4)
Mechanical ventilation days
Days of mechanical ventilation from study drug administration to discharge of ICU
Measured: From administration to discharge hospital, up to 90 days
Length of hospital stay
The number of days the subject stayed in the hospital
Measured: From administration to discharge hospital, up to 90 days
Length of ICU stay
The number of days the subject stayed in the ICU
Measured: From administration to discharge ICU, up to 90 days
incidence of septic shock
incidence of septic shock
Measured: From administration to discharge ICU, up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start13 Jun 2023
- Primary completion15 Jul 2023 (estimated)
- Study completion15 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914428
- Sponsor's protocol ID
- 2020BIPROSALDH2
- Status last verified
- Jun 2023
- First submitted
- 13 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers to Predict Acute Respiratory Distress Syndrome(ARDS) in Patients With Sepsis
- ClinicalTrials.gov ID
- NCT05914428
- Acronym / sponsor ID
- 2020BIPROSALDH2
- Conditions
- Sepsis
- Keywords
- sepsis, ARDS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- 15 Jul 2023 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sepsis | – | Other: ALDH2 rs671 mutationWe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALDH2 rs671 mutationWe 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 | Other | sepsis |
Primary outcome
Temporal dynamics of PaO2/FiO2
Time frame: From ICU administration to days 7
PaO2/FiO2 or SpO2 / FiO2 was recorded on ICU admission，day 1 and 7
Progression to ARDS within 7 days (Berlin criteria)
Time frame: From ICU administration to days 7
The proportion of patients with sepsis progressing to ARDS
4 secondary outcomes
Mechanical ventilation days
Time frame: From administration to discharge hospital, up to 90 days
Length of hospital stay
Time frame: From administration to discharge hospital, up to 90 days
Length of ICU stay
Time frame: From administration to discharge ICU, up to 90 days
incidence of septic shock
Time frame: From administration to discharge ICU, up to 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiaojiao Pang, Dr (18560089129, jiaojiaopang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temporal dynamics of PaO2/FiO2 (time frame: From ICU administration to days 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.