CClinicalTrials.gg
Status unknownNCT00657306AILDUpdated Apr 14, 2008

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

A Phase 2 interventional study of hydrocortisone and dextrose solution 5% in Cirrhosis With Ascites, sponsored by University of Turin, Italy. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2008-04-14.

Sponsored by University of Turin, Italy · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2008), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cirrhosis With Ascites

Keywords

  • Cirrhosis
  • Ascites
  • Adrenal insufficiency
  • Hepatorenal syndrome
  • Portal hypertension
03

In context

Adrenal Insufficiency

132 studies on the registry are indexed under Adrenal Insufficiency; 26 are open to participants now.

This study's planned enrollment of 50 is above the median of 37 across 70 interventional studies indexed under Adrenal Insufficiency.

Browse Adrenal Insufficiency studies →

Lead sponsor

University of Turin, Italy is the lead sponsor of 206 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Cirrhosis with ascites, with or without hepatorenal syndrome

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    1

    Hydrocortisone, 50 mg/6 h per day

    Drug: hydrocortisone

  • Placebo comparator
    2

    dextrose solution 5%

    Drug: dextrose solution 5%

Interventions

  • Drughydrocortisone

    50 mg/6 h per day

  • Drugdextrose solution 5%

    dextrose solution 5% 100 ml/6 h per day

06

What researchers measure

Primary outcomes

  1. renal function

    Time frame: 10 days

07

Study locations

1 site
  • San Giovanni Battista Hospital
    Turin, 10126, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00657306
Lead sponsor
University of Turin, Italy
First posted
Apr 14, 2008
Start date
May 2008
Primary completion
Dec 2008 (estimated)
Completion
May 2009 (estimated)
Last update
Apr 14, 2008

Study contacts

Carlo Alessandria, MD
Contact
carloalessandria@libero.it
00390116335561
Monica Carello, MD
Contact
monicacarello@virgilio.it
00390116335569
Carlo Alessandria, MD
principal investigator · Division of gastroenterology and hepatology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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