Effect of Large Volume Paracentesis on Fatigue in Cirrhosis | NCT00603200

Studies
Effect of Large Volume Paracentesis on Fatigue in Cirrhosis

NCT00603200

Sponsor

Weill Medical College of Cornell University

Status

Withdrawn

Last Update Posted

Dec 12, 2023Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Ascites
Fatigue
Cirrhosis

Interventions

Not provided

Countries

United States

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

Dec 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Principal Investigator left institution

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jun 2008Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Jan 15, 2008

First Submission Date that Met QC Criteria

Jan 26, 2008

First Posted Date

Jan 28, 2008Estimated

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

Dec 5, 2023

Last Update Posted Date

Dec 12, 2023Actual

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

The purposeof this study is to determine the effect of a large volume paracentesis (procedure in whihc a catheter is placed to remove fluid from the abdomen) on the severity of fatigue i patients with cirrhosis (severe scarring of the liver) and large volume ascites (fluid in the abdomen).

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

Not provided

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

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Patients with cirrhosis, who have refractory ascites requiring large volume paracentesis

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement in Fatigue symptomatology, as defined by fatigue questionnairre		instantly

Secondary Outcomes

Measure	Description	Time Frame
Improvement in sleep		post paracentesis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ambulatory patient with cirrhosis
baseline Cr <2
ability to complete psychometric testing
refractory ascites

Exclusion Criteria:

Cr >2
history of Gastrointestinal bleed
history of infection
history of renal failure

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

Patients with cirrhosis and refractory ascites.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Samual Sigal, MD	Weill Medical College of Cornell University	Principal Investigator
Reem Sharaiha, MD	New York Hospital-Cornell/Columbia	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York Presbyterial, Weill Cornell medical College		New York	New York	10021	United States

Condition Browse Module

MeSH Terms

ID	Term
D001201	Ascites
D005221	Fatigue
D005355	Fibrosis

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided