Bacterial Infections in Cirrhotic Patients With Acute Sev... | NCT03204591

Studies
Bacterial Infections in Cirrhotic Patients With Acute Severe Liver Injury

NCT03204591

Sponsor

The Zhejiang Study Group for Organ Failure in Cirrhosis

Status

Unknown status

Last Update Posted

Jun 6, 2018Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Cirrhosis, Liver
Bacterial Infections
Acute Liver Injury

Interventions

No intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2017Actual

Primary Completion Date

Oct 18, 2018Estimated

Completion Date

Jan 18, 2019Estimated

First Submitted Date

Jun 27, 2017

First Submission Date that Met QC Criteria

Jun 29, 2017

First Posted Date

Jul 2, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2018

Last Update Posted Date

Jun 6, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shi Yu, Principal Investigator, The Zhejiang Study Group for Organ Failure in CirrhosisPrincipal Investigator

Lead Sponsor

The Zhejiang Study Group for Organ Failure in CirrhosisOTHER

Collaborators

Name	Class
Ningbo No.2 Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Acute hepatic insults including hepatitis flare-up, active alcohol assumption and hepatotoxic drug use are common in patients with cirrhosis especially in Eastern countries.These patients are at high risk of developing acute-on-chronic liver failure (ACLF) and associated with high short-term mortality. And the natural history of these patients is frequently complicated by bacterial infections, which lead to deterioration of underlying diseases. The present study is aimed to investigate the prevalance and risk factors of bacterial infections in those patients and its impact on in-hospital/short-term mortality.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LC with SALI		cirrhosis patients with severe acute liver injury	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	LC with SALI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of bacterial infection	Site,source, pathogen and severity	Within 3 months from admission

Secondary Outcomes

Measure	Description	Time Frame
28-day Mortality	Disease-associated mortality	Within 28 days after enrollment
90-day Mortality	Disease-associated mortality	Within 90 days after enrollment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The presence of cirrhosis confirmed by liver biopsy, endoscopy, radiological examination, or clinical evidence of prior hepatic de-compensation;
Flare up of acute severe liver injury within one month before enrollment. Acute severe liver injury is defined as: increase of serum bilirubin >=85mmol/L and international normalized ratio (INR)>=1.5 with a definite hepatic insult.

Exclusion Criteria:

(1)pregnancy; (2) disseminated maliganancy; (3)previously received a liver transplant; (4) HIV infection;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with cirrhosis of any etiology who had acute severe liver injury

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yu Shi, Doctor	Contact	86-0571-87236489		zjushiyu@zju.edu.cn

Overall Officials

Name	Affiliation	Role
Jifang Sheng, Doctor	Department of infectious disease, First Affiliated Hospital of Zhejiang University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Affiliated Hospital of Zhejiang University	Recruiting	Hangzhou	Zhejiang	310009	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008103	Liver Cirrhosis
D001424	Bacterial Infections

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes

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