FC Change From Day 1 to Day 3 Associated With SALD

NCT06403553 | Completed DMC

• 1 other identifier: 2024-04-22
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

As defined by sepsis 3.0, sepsis is a clinical syndrome caused by disordered host response to serious infection，leading to multiple organ dysfunction1. Sepsis-associated liver dysfunction (SALD) is one of the most frequently complication in sepsis, possessing high morbidity and mortality2. A close relationship exists between the gut and the liver, and their bidirectional interaction was commonly known as the 'gut-liver' axis3. Systemic inflammation and hypoperfusion play a crucial role in the pathophysiological processes of acute gastrointestinal injury (AGI) in sepsis4. The translocation of bacteria and toxins due to gut barrier injury during AGI can promote the entry of bacteria and their products into the liver through the portal circulation and lymphatic system, leading to the occurrence of SALD. Our previous study found that septic patients with abdominal infections and SALD suffered a higher incidence of AGI when compared with patients without SALD5. Faecal calprotectin (FC) is a convenient, non-invasive biomarker that has a good correlation with gut inflammation6. The FC concentration is proportional to neutrophil migration to the gut and correlates well with fecal leukocyte excretion7. Study found that FC concentrations were significantly higher in septic patients complicated with AGI than those without, and it can be used as an early indicator for the diagnosis of AGI8. However, the relationship between FC concentration and SALD in septic patient is unclear. We conducted a prospective study to explore the potential association between FC concentration and SALD in septic patients. The dynamic changes in the FC concentration from day 1 to 3 after enrollment were also investigated.

Conditions

Liver Dysfunction

Keywords

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

patients does not fulfill any of the following conditions during ICU stay: 1. Serum aminotransaminase levels \> 800 IU/L, including alanine aminotransferase and aspartate aminotransferase; 2. Total bilirubin \> 2 mg/dL.

Diagnostic Test: Fecal Calprotectin

SALD group

when patients meet either of the following two criteria under sepsis condition during ICU stay: 1. Serum aminotransaminase levels \> 800 IU/L, including alanine aminotransferase and aspartate aminotransferase; 2. Total bilirubin \> 2 mg/dL.

Diagnostic Test: Fecal Calprotectin

Interventions

Fecal Calprotectin DIAGNOSTIC_TEST

Fecal Calprotectin measurement on days 1and 3

SALD group; non-SALD group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All eligible patients were treated according to the sepsis 3.0 guidelines, including: control the source of infection, used antibiotic early and other supportive therapies to maintain organ function. Patients were divided into non-SALD and SALD groups according to SALD whether or not diagnosed during intensive care units (ICU) stay. Eligible patients also be excluded if the following occurs during the study period: 1. deviation from the study protocol for any reason; 2. have other causes of liver injury, such as drugs and poisons; 3. diagnosis of SALD within 72 hours after enrollment; 4. patients or their relatives decided to withdraw from the study.

You may qualify if:

• adult patients with sepsis

You may not qualify if:

• had diseases originating in the gastrointestinal tract, such as gastrointestinal malignancies and inflammatory bowel disease (IBD);
• complicated by severe chronic liver diseases, such as decompensated cirrhosis and advanced liver cancer;
• hospitalization for primary hepatobiliary disease, such as trauma, hepatitis and hepatic abscess;
• already diagnosed SALD at enrollment;
• were discharged or died within 72 hours after enrollment;
• were pregnant.

Sponsors & Collaborators

• Chinese Medical Association: lead

Study Sites (1)

Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

Related Publications (2)

• Zhang B, Chen X, He C, Su T, Cao K, Li X, Duan J, Chen M, Zhu Z, Yu W. Acute gastrointestinal injury and altered gut microbiota are related to sepsis-induced cholestasis in patients with intra-abdominal infection: a retrospective and prospective observational study. Front Med (Lausanne). 2023 Jul 27;10:1144786. doi: 10.3389/fmed.2023.1144786. eCollection 2023.

  PMID: 37575984 BACKGROUND

• Li J, Ren Y, Gao C, Zhang K, Zheng F, Kang J. Evaluation of Fecal Calprotectin, D-Lactic Acid and Bedside Gastrointestinal Ultrasound Image Data for the Prediction of Acute Gastrointestinal Injury in Sepsis Patients. Front Med Technol. 2021 Nov 1;3:733940. doi: 10.3389/fmedt.2021.733940. eCollection 2021.

  PMID: 35047957 RESULT

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 8, 2024
• Study Start: January 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: May 8, 2024

Record last verified: 2023-01

Locations

CN (1)