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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Ascites
Adrenal Gland Diseases
Endocrine System Diseases
Pathologic Processes
Cortisol succinate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone-17-butyrate
Pharmaceutical Solutions
Anti-Inflammatory Agents
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014