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

Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Stress Doses of Hydrocortisone on Renal Function and on Liver and Systemic Haemodynamics

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00657306
Acronym
AILD
Enrollment
50
Registered
2008-04-14
Start date
2008-05-31
Completion date
2009-05-31
Last updated
2008-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis With Ascites

Keywords

Cirrhosis, Ascites, Adrenal insufficiency, Hepatorenal syndrome, Portal hypertension

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.

Interventions

DRUGhydrocortisone

50 mg/6 h per day

DRUGdextrose solution 5%

dextrose solution 5% 100 ml/6 h per day

Sponsors

University of Turin, Italy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frame
renal function10 days

Countries

Italy

Contacts

Primary ContactCarlo Alessandria, MD
carloalessandria@libero.it00390116335561
Backup ContactMonica Carello, MD
monicacarello@virgilio.it00390116335569

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026