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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

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 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


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



Primary Outcome Measures :
  1. renal function [ Time Frame: 10 days ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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

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

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