Adrenal Insufficiency in Cirrhotics With Ascites. Effects... | NCT00657306

Studies
Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Hydrocortisone on Renal and Haemodynamic Function

NCT00657306

Sponsor

University of Turin, Italy

Status

Unknown status

Last Update Posted

Apr 14, 2008Estimated

Enrollment

50Estimated

Phase

Phase 2

Conditions

Cirrhosis With Ascites

Interventions

hydrocortisone
dextrose solution 5%

Countries

Italy

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

Apr 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Dec 2008Estimated

Completion Date

May 2009Estimated

First Submitted Date

Apr 9, 2008

First Submission Date that Met QC Criteria

Apr 11, 2008

First Posted Date

Apr 14, 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

Apr 11, 2008

Last Update Posted Date

Apr 14, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Relative adrenal insufficiency (RAI) is an well known condition in patients with septic shock. Liver failure (including chronic liver failure)and sepsis are both characterized by hyperdynamic circulatory failure (with low arterial pressure) and high levels of pro-inflammatory cytokines.

Hydrocortisone has been shown to have a beneficial effect on clinical outcome. The aim of this study is to evaluate the incidence of RAI in the different settings of ascites in cirrhosis and the usefulness of hydrocortisone in this context.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Hydrocortisone, 50 mg/6 h per day	Drug: hydrocortisone
2	Placebo Comparator	dextrose solution 5%	Drug: dextrose solution 5%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hydrocortisone	Drug	50 mg/6 h per day	1
dextrose solution 5%

Measure	Description	Time Frame
renal function		10 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cirrhosis with ascites, with or without hepatorenal syndrome

Exclusion Criteria:

Age < 18 and > 75 years
Shock or bacterial infection present at the inclusion or during the previous week
Bleeding present at the inclusion or during the previous week
Multifocal HCC
Organic renal failure
Hearth or pulmonary failure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Carlo Alessandria, MD	Contact	00390116335561		carloalessandria@libero.it
Monica Carello, MD	Contact	00390116335569		monicacarello@virgilio.it

Overall Officials

Name	Affiliation	Role
Carlo Alessandria, MD	Division of gastroenterology and hepatology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Giovanni Battista Hospital		Turin		10126	Italy

Condition Browse Module

MeSH Terms

ID	Term
D005355	Fibrosis
D001201	Ascites
D000309	Adrenal Insufficiency
D006530	Hepatorenal Syndrome
D006975	Hypertension, Portal

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D000307	Adrenal Gland Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006854	Hydrocortisone

Ancestor Terms

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided