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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
Information provided by:
University of Turin, Italy Identifier:
First received: April 9, 2008
Last updated: April 11, 2008
Last verified: April 2008

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 2

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:

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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00657306

Contact: Carlo Alessandria, MD 00390116335561
Contact: Monica Carello, MD 00390116335569

San Giovanni Battista Hospital
Turin, Italy, 10126
Sponsors and Collaborators
University of Turin, Italy
Principal Investigator: Carlo Alessandria, MD Division of gastroenterology and hepatology
  More Information

Responsible Party: AOU San Giovanni Battista di Torino, Carlo Alessandria 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:
Adrenal insufficiency
Hepatorenal syndrome
Portal hypertension

Additional relevant MeSH terms:
Adrenal Insufficiency
Pathologic Processes
Adrenal Gland Diseases
Endocrine System Diseases
Pharmaceutical Solutions
Epinephryl borate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone acetate
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
Vasoconstrictor Agents
Anti-Inflammatory Agents processed this record on October 25, 2016