Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Hydrocortisone on Renal and Haemodynamic Function - Full Text View

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

The recruitment status of this study is unknown because the information has not been verified recently.

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

First Received on April 9, 2008. Last Updated on April 11, 2008 History of Changes

Sponsor:	University of Turin, Italy
Information provided by:	University of Turin, Italy
ClinicalTrials.gov Identifier:	NCT00657306

Purpose

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	Intervention	Phase
Cirrhosis With Ascites	Drug: hydrocortisone Drug: dextrose solution 5%	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis High Blood Pressure

Drug Information available for: Hydrocortisone acetate Hydrocortisone Epinephrine bitartrate Epinephrine Dextrose Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone cypionate Cortisol succinate Cortisol 21-phosphate

U.S. FDA Resources

Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:

renal function [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	May 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	AOU San Giovanni Battista di Torino, Carlo Alessandria
ClinicalTrials.gov Identifier:	NCT00657306 History of Changes
Other Study ID Numbers:	AILD
Study First Received:	April 9, 2008
Last Updated:	April 11, 2008
Health Authority:	Italy: National Institute of Health

Keywords provided by University of Turin, Italy:

Cirrhosis
Ascites
Adrenal insufficiency
Hepatorenal syndrome
Portal hypertension

Additional relevant MeSH terms:

Adrenal Insufficiency
Addison Disease
Ascites
Liver Cirrhosis
Fibrosis
Adrenal Gland Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

Pathologic Processes
Liver Diseases
Digestive System Diseases
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012