NCT00657306

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2008

Completed
17 days until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

April 14, 2008

Status Verified

April 1, 2008

Enrollment Period

7 months

First QC Date

April 9, 2008

Last Update Submit

April 11, 2008

Conditions

Cirrhosis With Ascites

Keywords

CirrhosisAscitesAdrenal insufficiencyHepatorenal syndromePortal hypertension

Outcome Measures

Primary Outcomes (1)

  • renal function

    10 days

Study Arms (2)

1

EXPERIMENTAL

Hydrocortisone, 50 mg/6 h per day

Drug: hydrocortisone

2

PLACEBO COMPARATOR

dextrose solution 5%

Drug: dextrose solution 5%

Interventions

hydrocortisoneDRUG

50 mg/6 h per day

1
dextrose solution 5%DRUG

dextrose solution 5% 100 ml/6 h per day

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cirrhosis with ascites, with or without hepatorenal syndrome

You may not qualify if:

  • Age \< 18 and \> 75 years
  • Multifocal HCC
  • Organic renal failure
  • Hearth or pulmonary failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Giovanni Battista Hospital

Turin, 10126, Italy

Location

MeSH Terms

Conditions

FibrosisAscitesAdrenal InsufficiencyHepatorenal SyndromeHypertension, Portal

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsAdrenal Gland DiseasesEndocrine System DiseasesLiver DiseasesDigestive System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Officials

  • Carlo Alessandria, MD

    Division of gastroenterology and hepatology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlo Alessandria, MD

CONTACT

00390116335561carloalessandria@libero.it

Monica Carello, MD

CONTACT

00390116335569monicacarello@virgilio.it

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 9, 2008

First Posted

April 14, 2008

Study Start

May 1, 2008

Primary Completion

December 1, 2008

Study Completion

May 1, 2009

Last Updated

April 14, 2008

Record last verified: 2008-04

Locations

IT(1)