Elevated Initial APRI Value Was Associated With SALD

NCT05999331 | Unknown DMC

• 1 other identifier: 2023-06-03
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Liver Dysfunction; Sepsis-associated Liver Dysfunction

Outcome Measures

Primary Outcomes (1)

• Occurrence of SALD

  Whether SALD occurs

  30 days after ICU admission

Secondary Outcomes (1)

• mortality

  30 days after ICU admission

Study Arms (2)

Non-SALD group

SALD 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.

Other: initial aspartate aminotransferase (AST) to platelet (PLT) ratio index

SALD group

SALD 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).

Other: initial aspartate aminotransferase (AST) to platelet (PLT) ratio index

Interventions

initial aspartate aminotransferase (AST) to platelet (PLT) ratio index OTHER

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

Non-SALD group; SALD group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• adult sepsis patients (≥18 years)

You may not qualify if:

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

Sponsors & Collaborators

• Chinese Medical Association: lead

Study Sites (1)

Institute of General Surgery of Jinling Hospital

Nanjing, Jiangsu, 210002, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 31497584 BACKGROUND

• 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.

  PMID: 33274619 BACKGROUND

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Wenkui Yu, professor

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  STUDY CHAIR

Central Study Contacts

Beiyuan Zhang, M.S.

CONTACT

15005170137; 1083537599@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 21, 2023
• Study Start: January 1, 2019
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)