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

NCT ID: NCT00657306

Last Updated: 2008-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-05-31

Brief Summary

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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

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Conditions

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Cirrhosis With Ascites

Keywords

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Cirrhosis Ascites Adrenal insufficiency Hepatorenal syndrome Portal hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Hydrocortisone, 50 mg/6 h per day

Group Type EXPERIMENTAL

hydrocortisone

Intervention Type DRUG

50 mg/6 h per day

2

dextrose solution 5%

Group Type PLACEBO_COMPARATOR

dextrose solution 5%

Intervention Type DRUG

dextrose solution 5% 100 ml/6 h per day

Interventions

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hydrocortisone

50 mg/6 h per day

Intervention Type DRUG

dextrose solution 5%

dextrose solution 5% 100 ml/6 h per day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turin, Italy

OTHER

Sponsor Role lead

Responsible Party

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Carlo Alessandria

Principal Investigators

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Carlo Alessandria, MD

Role: PRINCIPAL_INVESTIGATOR

Division of gastroenterology and hepatology

Locations

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San Giovanni Battista Hospital

Turin, , Italy

Site Status

Countries

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Italy

Central Contacts

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Carlo Alessandria, MD

Role: CONTACT

Phone: 00390116335561

Email: [email protected]

Monica Carello, MD

Role: CONTACT

Phone: 00390116335569

Email: [email protected]

Other Identifiers

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AILD

Identifier Type: -

Identifier Source: org_study_id