Impact of Acute Decompensation in Patients of Cirrhosis W... | NCT03005587

Studies
Impact of Acute Decompensation in Patients of Cirrhosis With or Without Prior Decompensation

NCT03005587

Sponsor

Institute of Liver and Biliary Sciences, India

Status

Withdrawn

Last Update Posted

Jun 26, 2018Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Acute Decompensation in Liver Cirrhosis

Interventions

Not provided

Countries

India

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

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of Funds

Expanded Access Info

Start Date

Dec 31, 2016Estimated

Primary Completion Date

Mar 1, 2017Estimated

Completion Date

Mar 1, 2017Estimated

First Submitted Date

Dec 23, 2016

First Submission Date that Met QC Criteria

Dec 23, 2016

First Posted Date

Dec 29, 2016Estimated

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 22, 2018

Last Update Posted Date

Jun 26, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This a prospective observational study in Chronic Liver Disease patients admitted or seen in OPD, Department of Hepatology, Institute of Liver and Biliary Sciences, India. The study will be conducted in a period of three months starting September 2016 in sample size of 80 . A detailed proforma including history and examination and routine blood investigations will be noted. The patients will undergo close follow up at 0, 7, 15, 30, 45, 60, 90 days and similar activities will be repeated at every visit.

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

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Spontaneous recovery or liver transplant or death in both groups		90 days

Secondary Outcomes

Measure	Description	Time Frame
Cause of acute decompensation		3 months
Severity and duration of prior as well as present decompensation		3 months
Improvement in severity assessment Indices Model for End Stage Liver Disease in both groups.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cirrhosis with decompensation in a period of 3 months in form of ascites, jaundice, Hepatic Encephalopathy, Acute Variceal bleed irrespective of prior decompensation.
Age 18-70 years
Valid consent

Exclusion Criteria:

HepatoCellular Carcinoma
Admitted and survival less than 48 hrs
Pregnant
Acute Liver Failure
Post transplant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Chronic liver disease patients admitted or seen in Out Patient Department, Department of Hepatology, Institute of Liver & Biliary Sciences, India.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Liver and Biliary Sciences.		New Delhi	National Capital Territory of Delhi	110070	India

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

Label	Type	Description	Intervention Names
Cirrhotics with no previous decompensation
Cirrhotics with previous one or more than one decompensation