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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
Sponsor:
Information provided by:
University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT00657306
First received: April 9, 2008
Last updated: April 11, 2008
Last verified: April 2008
History of Changes
  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 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:

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 Gland Diseases
Adrenal Insufficiency
Addison Disease
Ascites
Liver Cirrhosis
Fibrosis
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Liver Diseases
 Digestive System Diseases
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on May 21, 2013