Liver CirrhosisPhase 3NCT01311167
Treatment of Sodium Retention in Liver Cirrhosis With Dexamethasone
A Phase 3 study testing Dexamethasone in people with Liver Cirrhosis, run by Insel Gruppe AG, University Hospital Bern at 3 sites in Switzerland.
Trial summary
Accumulation of salt and water in patients with liver disease (so called liver cirrhosis) is possibly related to the increased effect of steroid hormones on salt reabsorption in the kidney. By reducing overall steroid production with the dexamethasone the accumulation of salt and water could be prevented. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Feb 2011to Nov 2011
- Phase
- Phase 3
- 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
- patients with established liver cirrhosis (biopsy or biochemically)
- hepatorenal syndrome type 1 or 2 (with a serum creatinin >175 umol/l)
- age between 18 and 75
- no bacterial infection
- no cardiovascular or extrahepatic disease (end of life)
- no structural kidney disease
- no hepatocellular carcinoma
Who cannot join
- age under 15 or over 75
- treatment with corticosteroids (dexamethasone included)
- bacterial infection
- cardiovascular or extrahepatic disease (end of life)
- structural kidney disease (indicated by hematuria, proteinuria)
- hepatocellular carcinoma
- mental disability
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
University Hospital Inselspital
Bern, Canton of Bern, 3010
University Hospital Geneva
Geneva, Canton of Geneva
University Hospital Lausanne
Lausanne, Canton of Vaud
About this study
Official title: Prospective Randomized Double Blind Placebo Controlled Intervention Study of the Effect of Dexamethasone on the Sodium Retention in Patients With Liver Cirrhosis
Accumulation of salt and water in patients with liver disease (so called liver cirrhosis) is possibly related to the increased effect of steroid hormones on salt reabsorption in the kidney. By reducing overall steroid production with the dexamethasone the accumulation of salt and water could be prevented.
- Conditions
- Liver Cirrhosis
- Being tested
- Dexamethasone, Placebo
- Keywords
- Dexamethasone, Sodium
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Daily administration of 2 mg of dexamethasone for 4 days
PlaceboDrug
Daily administration of 2 mg of placebo for 4 days
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Not described Receives: Drug: Dexamethasone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily sodium excretion of sodium in the urine
Measured: 4 days
Secondary outcomes (6)
Daily potassium excretion
Measured: 4 days
weight reduction
Measured: 4 days
Reduction of doses of diuretics
Measured: 4 days
Reduction of ascites
Measured: 4 days
Reduction of cortisol excretion in the urine
Measured: 4 days
Reduction of cortisol levels in the urine
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: Recruitment problems (not enough patients were found who met eligibility criteria)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311167
- Sponsor's protocol ID
- Dexa_Cirr_2011
- Status last verified
- Apr 2013
- First submitted
- 7 Mar 2011
- Last updated
- 18 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Double Blind Placebo Controlled Intervention Study of the Effect of Dexamethasone on the Sodium Retention in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT01311167
- Acronym / sponsor ID
- Dexa_Cirr_2011
- Conditions
- Liver Cirrhosis
- Keywords
- Dexamethasone, Sodium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment problems (not enough patients were found who met eligibility criteria)
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University Hospital, Geneva, University of Lausanne Hospitals
- Study start
- Feb 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 9 Mar 2011 (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.
Accumulation of salt and water in patients with liver disease (so called liver cirrhosis) is possibly related to the increased effect of steroid hormones on salt reabsorption in the kidney. By reducing overall steroid production with the dexamethasone the accumulation of salt and water could be prevented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: Dexamethasone |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patients with established liver cirrhosis (biopsy or biochemically)
- hepatorenal syndrome type 1 or 2 (with a serum creatinin >175 umol/l)
- age between 18 and 75
- no bacterial infection
- no cardiovascular or extrahepatic disease (end of life)
Key exclusion criteria (7 listed)
- age under 15 or over 75
- treatment with corticosteroids (dexamethasone included)
- bacterial infection
- cardiovascular or extrahepatic disease (end of life)
- structural kidney disease (indicated by hematuria, proteinuria)
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 |
|---|---|---|
| DexamethasoneDaily administration of 2 mg of dexamethasone for 4 days | Drug | Dexamethasone |
| PlaceboDaily administration of 2 mg of placebo for 4 days | Drug | Placebo |
Primary outcome
Daily sodium excretion of sodium in the urine
Time frame: 4 days
6 secondary outcomes
Daily potassium excretion
Time frame: 4 days
weight reduction
Time frame: 4 days
Reduction of doses of diuretics
Time frame: 4 days
Reduction of ascites
Time frame: 4 days
Reduction of cortisol excretion in the urine
Time frame: 4 days
Reduction of cortisol levels in the urine
Time frame: 4 days
Results and safety
The study was stopped early (reason given: Recruitment problems (not enough patients were found who met eligibility criteria)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone in people with Liver Cirrhosis, run by Insel Gruppe AG, University Hospital Bern at 3 sites in Switzerland.
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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 18 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment problems (not enough patients were found who met eligibility criteria)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily sodium excretion of sodium in the urine (time frame: 4 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 18 Apr 2013.