Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04647201
Status:
UNKNOWN
Last Update Posted:
2020-11-30
First Post:
2020-11-22
Brief Title:
Study of Biomarkers in Patients of Sepsis Complicated With Gastrointestinal Dysfunction
Sponsor:
Jianbo Yu
Organization:
Tianjin Nankai Hospital
Study Overview
Official Title:
Study of Biomarkers in Blood and Tissue Samples of Septic Patients Complicated With Gastrointestinal Dysfunction
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
1 Title Study of Biomarkers in Patients of Sepsis Complicated With Gastrointestinal Dysfunction
2 Research center Single-center study
3 Design of the research A prospective and cohort study
4 Object of the research Patients with age18 years those who meet the diagnostic criteria of sepsis 30 complicated with GI and grouped into GI group and non-GI adults as control
5 Sample size of the research Not less than 30 patients in each group
6 Research approach After admission to ICU patients were assigned to the indicated groups according to the criteria In addition blood samples were collected within 24 hours for detecting serum levels of HO-1 PINK1 PLK1as well as oxidative stress and inflammatory markersFor those who requiring intestinal surgery as treatment the intestinal tissue specimens are retained
7 Aim of the research The find out the potential biomarkers in serum to help the diagnose and management of gastrointestinal dysfunction in septic patients
8 Statistical analysis Analytical study
9 The estimated duration of the study1-2 years
2 Research center Single-center study
3 Design of the research A prospective and cohort study
4 Object of the research Patients with age18 years those who meet the diagnostic criteria of sepsis 30 complicated with GI and grouped into GI group and non-GI adults as control
5 Sample size of the research Not less than 30 patients in each group
6 Research approach After admission to ICU patients were assigned to the indicated groups according to the criteria In addition blood samples were collected within 24 hours for detecting serum levels of HO-1 PINK1 PLK1as well as oxidative stress and inflammatory markersFor those who requiring intestinal surgery as treatment the intestinal tissue specimens are retained
7 Aim of the research The find out the potential biomarkers in serum to help the diagnose and management of gastrointestinal dysfunction in septic patients
8 Statistical analysis Analytical study
9 The estimated duration of the study1-2 years
Detailed Description:
This study is a single-center prospective cohort study In this study the serum samples of septic patients complicated with or without GI are detected The serum levels of HO-1 PINK1 PLK1as well as oxidative stress and inflammatory markers are compared in different groups For those who requiring intestinal surgery as treatment the intestinal tissue specimens are retained Meanwhile the clinical symptoms intestinal motility indicators and intestinal barrier indicators are recorded In addition a biomarker model was established to provide important reference for diagnose and management of gastrointestinal dysfunction in septic patients
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