Cirrhosis With AscitesPhase 2AILDNCT00657306
Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Hydrocortisone on Renal and Haemodynamic Function
A Phase 2 study testing hydrocortisone and dextrose solution 5% in people with Cirrhosis With Ascites, run by University of Turin, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis With Ascites
- What is being tested?
- hydrocortisone and dextrose solution 5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- May 2008to May 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis with ascites, with or without hepatorenal syndrome
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Stress Doses of Hydrocortisone on Renal Function and on Liver and Systemic Haemodynamics
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.
- Conditions
- Cirrhosis With Ascites
- Being tested
- hydrocortisone, dextrose solution 5%
- Keywords
- Cirrhosis, Ascites, Adrenal insufficiency, Hepatorenal syndrome, Portal hypertension
- Medical subject headings
- Fibrosis, Ascites, Adrenal Insufficiency, Hepatorenal Syndrome, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrocortisoneDrug
50 mg/6 h per day
dextrose solution 5%Drug
dextrose solution 5% 100 ml/6 h per day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Hydrocortisone, 50 mg/6 h per day Receives: Drug: hydrocortisone |
| 2 | Placebo comparator | dextrose solution 5% Receives: Drug: dextrose solution 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal function
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2008 (estimated)
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis With AscitesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Investigators
- Carlo Alessandria, MD, Principal investigator, Division of gastroenterology and hepatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657306
- Sponsor's protocol ID
- AILD
- Acronym
- AILD
- Status last verified
- Apr 2008
- First submitted
- 9 Apr 2008
- Last updated
- 14 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Stress Doses of Hydrocortisone on Renal Function and on Liver and Systemic Haemodynamics
- ClinicalTrials.gov ID
- NCT00657306
- Acronym / sponsor ID
- AILD / AILD
- Conditions
- Cirrhosis With Ascites
- Keywords
- Cirrhosis, Ascites, Adrenal insufficiency, Hepatorenal syndrome, Portal hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 14 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: hydrocortisoneHydrocortisone, 50 mg/6 h per day |
| 2 | Placebo comparator | Drug: dextrose solution 5%dextrose solution 5% |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cirrhosis with ascites, with or without hepatorenal syndrome
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydrocortisone50 mg/6 h per day | Drug | 1 |
| dextrose solution 5%dextrose solution 5% 100 ml/6 h per day | Drug | 2 |
Primary outcome
renal function
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Alessandria, MD principal investigator
Division of gastroenterology and hepatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hydrocortisone and dextrose solution 5% in people with Cirrhosis With Ascites, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlo Alessandria, MD (00390116335561, carloalessandria@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
renal function (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2008.