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Liver DysfunctionNCT05999331

Elevated Initial APRI Value Was Associated With SALD

An observational study of Liver Dysfunction and Sepsis-associated Liver Dysfunction, run by Chinese Medical Association at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Sepsis, characterized by severe organ dysfunction related to a dysregulated immune response to infection, is often life-threatening in clinical settings. Sepsis can progress to multiple organ dysfunction syndrome (MODS), causing a great risk of mortality. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
initial aspartate aminotransferase (AST) to platelet (PLT) ratio index
How many people
160 participants
Where
1 siteChina
Study dates
1 Jan 2019to 30 Sep 2023
How long will I take part?
30 Days
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 90 years
  • All sexes
  • Adult, Older adult

Study population: Briefly, patients with confirmed or suspected foci of infectious and a concurrent SOFA≥2 were diagnosed with sepsis. SALD was diagnosed by the following criteria: (1) ALT or AST≥20 folds upper limit of normal level; or (2) TBIL≥2.0 mg/dL.

Who may be able to join

  • adult sepsis patients (≥18 years)

Who cannot join

  • all types of chronic liver disease;
  • viral hepatitis;
  • primary acute cholangiopathies;
  • cholecystitis;
  • hepatic infarction;
  • liver necrosis;
Show all 9Show fewer
  • liver trauma;
  • length of ICU stay < 24 hours;
  • Patients without simultaneous AST and PLT data in the first 24 hours after ICU admission.

Trial locations and contacts

1 site in 1 country.

Beiyuan Zhang, M.S. contact

15005170137

1083537599@qq.com

China1 site, 1 recruiting
  • Institute of General Surgery of Jinling Hospital

    Nanjing, Jiangsu, 210002

    Wenkui Yu, Ph.D., 13701582986, yudrnj@163.com

    Recruiting

Other trials in China

About this study

Official title: Elevated Initial APRI Value Was Associated With the Development of Sepsis-associated Liver Dysfunction in Adult Patients With Sepsis

Sepsis, characterized by severe organ dysfunction related to a dysregulated immune response to infection, is often life-threatening in clinical settings. Sepsis can progress to multiple organ dysfunction syndrome (MODS), causing a great risk of mortality. As a vital immune and metabolic organ, liver often suffers damage in this process and often associated with severe adverse consequences. Compared to general sepsis population, sepsis-associated liver dysfunction (SALD) has a higher mortality, up to 68.6%.

The aspartate aminotransferase (AST) to platelet (PLT) ratio index (APRI), which can be calculated from conventional laboratory indicators, has long been used in the evaluation of liver damage and fibrosis in patients with hepatitis and nonalcoholic fatty liver disease. AST is a sensitive indicator of early liver function impairment. Additionally, PLT also plays a crucial role in sepsis-induced MODS through regulating inflammation, maintaining tissue integrity, and defending against infection. Study found that APRI was a good predictor of SALD occurrence in pediatric patients with sepsis. Furthermore, APRI has also been used to predict the prognostic in septic patients with no history of chronic liver disease.

We conducted a retrospective study based on data from the Medical Information Mart for Intensive Care IV version 2.2 (MIMIC-IV, v2.2) and our own hospital to explore the potential association of APRI with the occurrence of SALD in adult patients with sepsis. Furthermore, we also evaluated the performance of APRI in hypoxic hepatitis and sepsis induced cholestasis (SIC), which are two subtypes of SALD.

Read the detailed description

We included adult sepsis patients (≥18 years) as study participants, but only those who had data available for their first hospitalization and first ICU admission were enrolled in our study, if they had multiple admission records in the database. Exclusion criteria include: 1) all types of chronic liver disease; 2) viral hepatitis; 3) primary acute cholangiopathies; 4) cholecystitis; 5) hepatic infarction; 6) liver necrosis; 7) liver trauma; 8) length of ICU stay < 24 hours. Patients without simultaneous AST and PLT data in the first 24 hours after ICU admission were also excluded.

The following indicators were extracted directly or derived from the database(MIMIC IV): age; weight; gender; comorbidity, including hypertension, old myocardial infarct, chronic heart failure, cerebrovascular disease, chronic pulmonary disease, chronic renal disease and diabetes; infection site, including blood, lung, skin and soft tissue, abdominal cavity and urinary tract; disease severity scores within the first day of ICU admission, including Acute Physiology Score III (APS III), Sequential Organ Failure Assessment (SOFA), Logistic Organ Dysfunction Score (LODS), Oxford Acute Severity of illness Score (OASIS) and Simplified Acute Physiology Score II (SAPS II); mean vital signs in first 24h, including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), respiratory rate (RR), temperature and pulse oxygen saturation (SPO2); treatment received within the first day of ICU admission, including invasive ventilation, vasopressor therapy, renal replacement therapy and parenteral nutrition (PN) support; initial laboratory parameters, including white blood cell (WBC) count, hemoglobin, hematocrit, mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), mean corpuscular volume (MCV), red blood cell (RBC), red blood cell distribution width (RDW), platelet, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), alkaline phosphatase (ALP), albumin, blood urea nitrogen (BUN), creatinine, bicarbonate, anionic gap, sodium, potassium, chloride, total calcium, glucose, prothrombin time (PT), partial prothrombine time (APTT), international normalized ratio (INR) and APRI; clinical outcome measures, including intensive care unit (ICU) length of stay (LOS), hospital LOS, ICU mortality, in-hospital mortality, and 30-day mortality.

The disease severity scores, including APS III, SOFA, LODS, OASIS, SAPS II, are calculated using the SQL code provided by Johnson et al. APRI is calculated by (AST(IU/L)/ upper limits of normal)/PLT(k/uL)×100. Sepsis is diagnosed according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). Briefly, patients with confirmed or suspected foci of infectious and a concurrent SOFA≥2. SALD was diagnosed by the following criteria: (1) ALT or AST≥20 folds upper limit of normal level; or (2) TBIL≥2.0 mg/dL. SALD is further divided into hypoxic hepatitis and sepsis induced cholestasis (SIC), based on the presence or absence of elevated TBIL. Hypoxic hepatitis is diagnosed when elevated transaminase (>800 IU/L) is present only; and SIC is diagnosed when TBIL is elevated (≥2.0 mg/dL). Following the exclusion of ineligible patients, the data underwent a thorough examination, and extreme and erroneous values that failed logical checks were removed. Variables with missing data exceeding 30% of the sample size were excluded. For the remaining variables with missing values, the mean imputation method was applied to address them.

We first used the MIMIC IV database to assess the correlation between APRI and the occurrence of SALD using association analysis. We then validated these results using our own data.

Being tested
initial aspartate aminotransferase (AST) to platelet (PLT) ratio index
Medical subject headings
Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • initial aspartate aminotransferase (AST) to platelet (PLT) ratio indexOther

    All eligible patients were given antibiotics therapy, actively control infection source, as well as other supportive therapy to maintain organ function.

Study groups in NCT05999331
Study groupRoleWhat they receive
Non-SALD groupSALD did not occur in adult patients with sepsis during ICU stay.SALD was diagnosed by the following criteria: (1) ALT or AST≥20 folds upper limit of normal level; or (2) TBIL≥2.0 mg/dL.
Receives: Other: initial aspartate aminotransferase (AST) to platelet (PLT) ratio index
SALD groupSALD was occured in adult patients with sepsis during ICU stay.SALD was diagnosed by the following criteria: (1) ALT or AST≥20 folds upper limit of normal level; or (2) TBIL≥2.0 mg/dL. SALD is further divided into hypoxic hepatitis and sepsis induced cholestasis (SIC), based on the presence or absence of elevated TBIL. Hypoxic hepatitis is diagnosed when elevated transaminase (>800 IU/L) is present only; and SIC is diagnosed when TBIL is elevated (≥2.0 mg/dL).
Receives: Other: initial aspartate aminotransferase (AST) to platelet (PLT) ratio index

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of SALD

    Whether SALD occurs

    Measured: 30 days after ICU admission

Secondary outcomes (1)
  1. mortality

    Death at 30 days after ICU

    Measured: 30 days after ICU admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start1 Jan 2019
  3. Primary completion30 Sep 2023 (estimated)
  4. Study completion30 Sep 2023 (estimated)

Resources

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
Prospective
Enrolment
160 participants (estimated)
Target duration
30 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT05999331
Sponsor's protocol ID
2023-06-03
Status last verified
Jun 2023
First submitted
11 Aug 2023
Last updated
21 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The research is not over yet

Publications

  • Dou J, Zhou Y, Cui Y, Chen M, Wang C, Zhang Y. AST-to-Platelet Ratio Index as Potential Early-Warning Biomarker for Sepsis-Associated Liver Injury in Children: A Database Study. Front Pediatr. 2019 Aug 21;7:331. doi: 10.3389/fped.2019.00331. eCollection 2019.

    PubMed 31497584
  • Zhu X, Hu X, Qin X, Pan J, Zhou W. An elevated Fibrosis-4 score is associated with poor clinical outcomes in patients with sepsis: an observational cohort study. Pol Arch Intern Med. 2020 Dec 22;130(12):1064-1073. doi: 10.20452/pamw.15699. Epub 2020 Dec 4.

    PubMed 33274619

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Dysfunction and Sepsis-associated Liver Dysfunction, run by Chinese Medical Association 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 9 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 21 Aug 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 Beiyuan Zhang, M.S. (15005170137, 1083537599@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of SALD (time frame: 30 days after ICU admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05999331, which also lists 2 linked publications.

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 21 Aug 2023.

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