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

Primary Purpose

Cirrhosis With Ascites

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
hydrocortisone
dextrose solution 5%
Sponsored by
University of Turin, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis With Ascites focused on measuring Cirrhosis, Ascites, Adrenal insufficiency, Hepatorenal syndrome, Portal hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • San Giovanni Battista Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Hydrocortisone, 50 mg/6 h per day

dextrose solution 5%

Outcomes

Primary Outcome Measures

renal function

Secondary Outcome Measures

Full Information

First Posted
April 9, 2008
Last Updated
April 11, 2008
Sponsor
University of Turin, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT00657306
Brief Title
Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Hydrocortisone on Renal and Haemodynamic Function
Acronym
AILD
Official Title
Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Stress Doses of Hydrocortisone on Renal Function and on Liver and Systemic Haemodynamics
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
May 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Turin, Italy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis With Ascites
Keywords
Cirrhosis, Ascites, Adrenal insufficiency, Hepatorenal syndrome, Portal hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Hydrocortisone, 50 mg/6 h per day
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
dextrose solution 5%
Intervention Type
Drug
Intervention Name(s)
hydrocortisone
Intervention Description
50 mg/6 h per day
Intervention Type
Drug
Intervention Name(s)
dextrose solution 5%
Intervention Description
dextrose solution 5% 100 ml/6 h per day
Primary Outcome Measure Information:
Title
renal function
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlo Alessandria, MD
Phone
00390116335561
Email
carloalessandria@libero.it
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Carello, MD
Phone
00390116335569
Email
monicacarello@virgilio.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Alessandria, MD
Organizational Affiliation
Division of gastroenterology and hepatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Giovanni Battista Hospital
City
Turin
ZIP/Postal Code
10126
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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