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

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ClinicalTrials.gov Identifier: NCT00657306

Recruitment Status : Unknown

Verified April 2008 by University of Turin, Italy.
Recruitment status was: Not yet recruiting

First Posted : April 14, 2008

Last Update Posted : April 14, 2008

Sponsor:

Information provided by:

University of Turin, Italy

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cirrhosis With Ascites	Drug: hydrocortisone Drug: dextrose solution 5%	Phase 2

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	50 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Stress Doses of Hydrocortisone on Renal Function and on Liver and Systemic Haemodynamics
Study Start Date :	May 2008
Estimated Primary Completion Date :	December 2008
Estimated Study Completion Date :	May 2009

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: North American Indian childhood cirrhosis Familial glucocorticoid deficiency

Drug Information available for: Hydrocortisone acetate Hydrocortisone Hydrocortisone sodium succinate Hydrocortisone cypionate Dextrose Hydrocortisone valerate Hydrocortisone probutate Proctofoam-HC

Genetic and Rare Diseases Information Center resources: Hepatorenal Syndrome Hypoadrenalism

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1 Hydrocortisone, 50 mg/6 h per day	Drug: hydrocortisone 50 mg/6 h per day
Placebo Comparator: 2 dextrose solution 5%	Drug: dextrose solution 5% dextrose solution 5% 100 ml/6 h per day

Outcome Measures

Primary Outcome Measures :

renal function [ Time Frame: 10 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00657306

Contacts


Contact: Carlo Alessandria, MD	00390116335561	carloalessandria@libero.it
Contact: Monica Carello, MD	00390116335569	monicacarello@virgilio.it

Locations


Italy
San Giovanni Battista Hospital
Turin, Italy, 10126

Sponsors and Collaborators

University of Turin, Italy

Investigators


Principal Investigator:	Carlo Alessandria, MD	Division of gastroenterology and hepatology

More Information


Responsible Party:	AOU San Giovanni Battista di Torino, Carlo Alessandria
ClinicalTrials.gov Identifier:	NCT00657306 History of Changes
Other Study ID Numbers:	AILD
First Posted:	April 14, 2008 Key Record Dates
Last Update Posted:	April 14, 2008
Last Verified:	April 2008

Keywords provided by University of Turin, Italy:


Cirrhosis Ascites Adrenal insufficiency Hepatorenal syndrome Portal hypertension

Additional relevant MeSH terms:


Fibrosis Ascites Adrenal Insufficiency Pathologic Processes Adrenal Gland Diseases Endocrine System Diseases Pharmaceutical Solutions Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Cortisol succinate Hydrocortisone Epinephrine Racepinephrine Epinephryl borate Anti-Inflammatory Agents	Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic beta-Agonists Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Mydriatics Sympathomimetics Vasoconstrictor Agents

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