Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374511
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-07
Brief Title:
Prospective Cohort Study of Complications and Outcomes in Cirrhosis
Sponsor:
Nanfang Hospital Southern Medical University
Organization:
Nanfang Hospital Southern Medical University
Study Overview
Official Title:
The Complications and Outcomes of Acutely Decompensated Cirrhosis a Multi-center Nested Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
This is a multi-center nested cohort study intended to investigate the prevalence risk factors and outcomes of complications in patients with acutely decompensated cirrhosis especially focused on Cytomegalovirus CMV reactivation bacterial infections hepatic encephalopathy and Hepatorenal syndrome Patients diagnosed with acutely decompensated cirrhosis were enrolled Upon enrollment detailed baseline data were collected and samples were harvested Complications were assessed during hospitalization Post-discharge follow-up was conducted through telephonic interviews at Day 30 and Day 90
Detailed Description:
This is a multi-center nested cohort study intended to investigate the prevalence risk factors and outcomes of complications in patients with acutely decompensated cirrhosis especially focused on CMV reactivation bacterial infections hepatic encephalopathy and Hepatorenal syndrome Patients diagnosed with acute decompensated cirrhosis were enrolled Upon enrollment detailed baseline data were collected and samples including ascites feces plasma urine and PBMC were harvested Following enrollment patients were subjected to a rigorous follow-up regimen extending over a period of 90 days Complications were assessed every 3-4 days during hospitalization through a combination of laboratory and clinical evaluations Post-discharge follow-up was conducted through telephonic interviews at Day 30 and Day 90 Upon the emergence of new complications such as infections viral bacterial or fungal or hepatic encephalopathy a detailed complication-specific protocol was activated Per complications protocols as follows
Special complications protocols
Hepatic encephalopathy
1 The feces plasma and urine were collected at hepatic encephalopathy diagnosis before treatment and at Day 4 7 14 since hepatic encephalopathy treatment If patients were discharged before14 days post-hepatic encephalopathy the sample at discharge were collocated
2 The treatment strategy for HE is recorded
3 The HE severity assessments were carried out daily
CMV reactivation
1 The patients plasma were collected twice a week for the assessment of CMV reactivation The patients peripheral blood mononuclear cells PBMC samples were collected at baseline and at the time of diagnosis of CMV reactivation
2 The treatment strategy for CMV is recorded
Special complications protocols
Hepatic encephalopathy
1 The feces plasma and urine were collected at hepatic encephalopathy diagnosis before treatment and at Day 4 7 14 since hepatic encephalopathy treatment If patients were discharged before14 days post-hepatic encephalopathy the sample at discharge were collocated
2 The treatment strategy for HE is recorded
3 The HE severity assessments were carried out daily
CMV reactivation
1 The patients plasma were collected twice a week for the assessment of CMV reactivation The patients peripheral blood mononuclear cells PBMC samples were collected at baseline and at the time of diagnosis of CMV reactivation
2 The treatment strategy for CMV is recorded
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