Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403553
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2024-05-03
Brief Title:
FC Change From Day 1 to Day 3 Associated With SALD
Sponsor:
Chinese Medical Association
Organization:
Chinese Medical Association
Study Overview
Official Title:
The Dynamic Change of Fecal Calprotectin From Day 1 to Day 3 Was Associated With Sepsis-associated Liver Dysfunction
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
2024-04-22
Brief Summary:
As defined by sepsis 30 sepsis is a clinical syndrome caused by disordered host response to serious infectionleading 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
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
Detailed Description:
Study participants
This was a single-center prospective observational study enrolling consecutive adult patients with sepsis 18 years admitted to Nanjing Drum Tower Hospital between January 2023 to March 2024 The study protocol was approved by the Medical Ethics Committee of local institution number 2023-396-03 All patients or their immediate family members provided the informed consent and all study procedures were in line with the Declaration of Helsinki Exclusion criteria were
1 had diseases originating in the gastrointestinal tract such as gastrointestinal malignancies and inflammatory bowel disease IBD
2 complicated by severe chronic liver diseases such as decompensated cirrhosis and advanced liver cancer
3 hospitalization for primary hepatobiliary disease such as trauma hepatitis and hepatic abscess
4 already diagnosed SALD at enrollment
5 were discharged or died within 72 hours after enrollment
6 were pregnant
All eligible patients were treated according to the sepsis 30 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
Data collection and outcomes The primary study outcome was the FC concentration 5000 μgg which reflect the severity of gut inflammation Fecal samples were collected from patients on days 1 and 3 after inclusion using sterile tubes and stored at 4C and FC was measured within 48 hours of collection using commercial ELISA KAPEPKT849 Beijing North Institute of Biotechnology CoLtd Beijing China following the manufacturers instruction The following information were collected within the first 24 hours of enrollment including demographic characteristics including age gender and comorbidity the sources of infection disease severity scores including Acute Physiology and Chronic Health Evaluation APACHE II score and Sequential Organ Failure Assessment SOFA score complications including respiratory failure septic shock acute kidney injury AKI and AGI inflammatory factors including interleukin IL-1βIL-2 IL-4 IL-5 IL-6 IL-8 IL-10 IL-12 IL-17 interferon IFN-αIFN-γand tumor necrosis factor TNF other indicators including human leukocyte antigen HLA-DR albumin platelet and D-dimer were also recorded The following indicators were collected on days 1 and 3 after enrollment white blood cell WBC count neutrophil count lymphocyte count C-reactive protein procalcitonin and IL-6 Prognostic indicators included ICU length of stay LOS and ICU mortality were also recorded
Definitions
Sepsis and septic shock were diagnosed based on criteria established by the Sepsis 30 guidelines1 SALD was diagnosed when patients meet either of the following two criteria under sepsis condition9
1 Serum aminotransaminase levels 800 IUL including alanine aminotransferase and aspartate aminotransferase
2 Total bilirubin 2 mgdL AKI was diagnosed in accordance with the Kidney Disease Improving Global Outcomes clinical practice guidelines10 The diagnosis of AGI was based on the ESICM recommendations in 201211 The term FC1 was used to represent the FC concentration on day 1 and FC3 on day 3 The term ΔFC was used to represent the concentration of the FC3 minus the concentration of the FC1
This was a single-center prospective observational study enrolling consecutive adult patients with sepsis 18 years admitted to Nanjing Drum Tower Hospital between January 2023 to March 2024 The study protocol was approved by the Medical Ethics Committee of local institution number 2023-396-03 All patients or their immediate family members provided the informed consent and all study procedures were in line with the Declaration of Helsinki Exclusion criteria were
1 had diseases originating in the gastrointestinal tract such as gastrointestinal malignancies and inflammatory bowel disease IBD
2 complicated by severe chronic liver diseases such as decompensated cirrhosis and advanced liver cancer
3 hospitalization for primary hepatobiliary disease such as trauma hepatitis and hepatic abscess
4 already diagnosed SALD at enrollment
5 were discharged or died within 72 hours after enrollment
6 were pregnant
All eligible patients were treated according to the sepsis 30 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
Data collection and outcomes The primary study outcome was the FC concentration 5000 μgg which reflect the severity of gut inflammation Fecal samples were collected from patients on days 1 and 3 after inclusion using sterile tubes and stored at 4C and FC was measured within 48 hours of collection using commercial ELISA KAPEPKT849 Beijing North Institute of Biotechnology CoLtd Beijing China following the manufacturers instruction The following information were collected within the first 24 hours of enrollment including demographic characteristics including age gender and comorbidity the sources of infection disease severity scores including Acute Physiology and Chronic Health Evaluation APACHE II score and Sequential Organ Failure Assessment SOFA score complications including respiratory failure septic shock acute kidney injury AKI and AGI inflammatory factors including interleukin IL-1βIL-2 IL-4 IL-5 IL-6 IL-8 IL-10 IL-12 IL-17 interferon IFN-αIFN-γand tumor necrosis factor TNF other indicators including human leukocyte antigen HLA-DR albumin platelet and D-dimer were also recorded The following indicators were collected on days 1 and 3 after enrollment white blood cell WBC count neutrophil count lymphocyte count C-reactive protein procalcitonin and IL-6 Prognostic indicators included ICU length of stay LOS and ICU mortality were also recorded
Definitions
Sepsis and septic shock were diagnosed based on criteria established by the Sepsis 30 guidelines1 SALD was diagnosed when patients meet either of the following two criteria under sepsis condition9
1 Serum aminotransaminase levels 800 IUL including alanine aminotransferase and aspartate aminotransferase
2 Total bilirubin 2 mgdL AKI was diagnosed in accordance with the Kidney Disease Improving Global Outcomes clinical practice guidelines10 The diagnosis of AGI was based on the ESICM recommendations in 201211 The term FC1 was used to represent the FC concentration on day 1 and FC3 on day 3 The term ΔFC was used to represent the concentration of the FC3 minus the concentration of the FC1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None