Hepatorenal SyndromeNCT01932151
Treatment of Type-1 Hepatorenal Syndrome Associated With Sepsis
A study testing Terlipressin and albumin in people with Hepatorenal Syndrome, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Type 1 Hepatorenal syndrome (type-1 HRS) is a severe complication of patients with advanced cirrhosis characterized by marked renal failure and is associated with a very poor prognosis. Type-1 HRS is often precipitated by a bacterial infection, though it may occur spontaneously. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hepatorenal Syndrome
- What is being tested?
- Terlipressin and albumin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2012to Aug 2013
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis as diagnosed by liver biopsy or a combination of clinical, biochemical, ultrasonographic, and/or endoscopic findings.
- Age between 18 and 85 years.
- Presence of sepsis, as defined by active infection, and signs of Systemic Inflammatory Response Syndrome.
- Occurrence of type-1 HRS during the infection, as defined by standard diagnostic criteria.
Who cannot join
- Hepatocellular carcinoma outside the Milan criteria.
- Any severe extrahepatic condition, including cardiovascular, neurological, and organic kidney diseases.
- Septic or hypovolemic shock.
- Terminal condition (death expected in less than 48 hours).
- Lack of informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Terlipressin and Albumin in Patients With Type-1 Hepatorenal Syndrome Associated With Sepsis
Type 1 Hepatorenal syndrome (type-1 HRS) is a severe complication of patients with advanced cirrhosis characterized by marked renal failure and is associated with a very poor prognosis. Type-1 HRS is often precipitated by a bacterial infection, though it may occur spontaneously. It has been demonstrated that vasoconstrictor agents plus albumin are effective in the reversal of the renal failure. A large number of studies have shown that terlipressin improves renal function in patients with type 1 HRS; treatment is effective in 50-75% of patients approximately. Currently there are no specific studies about the treatment of type-1 HRS with ongoing infections.
Read the detailed description
All consecutive patients with cirrhosis hospitalized with an infection or who developed an infection during hospitalization for an acute decompensation of the disease in four university hospitals.
Criteria for inclusion were: 1/ cirrhosis as diagnosed by liver biopsy or a combination of clinical, biochemical, ultrasonographic, and/or endoscopic findings; 2/ age between 18 and 80 years; 3/ presence of sepsis, as defined by infection and signs of Systemic Inflammatory Response Syndrome; and 4/ occurrence of type-1 HRS during the infection, as defined by standard diagnostic criteria. Exclusion criteria were: 1/ hepatocellular carcinoma outside the Milan criteria; 2/ any severe extrahepatic condition, including cardiovascular, neurological, and organic kidney diseases; 3/ septic or hypovolemic shock; 4/ terminal condition (death expected in less than 48 hours); and 5/ lack of informed consent.
Aim: A proof of concept study to evaluate whether treatment with terlipressin and albumin in the course of an infection associated with type-1 HRS is effective and safe.
- Conditions
- Hepatorenal Syndrome
- Being tested
- Terlipressin and albumin
- Keywords
- type-1 HRS, active bacterial infections, terlipressin and albumin, kidney function
- Medical subject headings
- Hepatorenal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terlipressin and albuminDrug
Also called - Glypressyn, Ferring SA, Saint-Prex, Switzerland., - Albúmina Humana Grífols, Grífols , Barcelona, Spain.
Single-group study (Type-1 Hepatorenal Syndrome Associated With Active Infections) Terlipressin was initially given at a dose of 1 mg/4h as an intravenous bolus for 2 days. If at day 3 serum creatinine had decreased at least 25% of the pretreatment values, the dose of terlipressin was not modified. In the remaining patients, the dose was increased up to a maximum of 2 mg/4h. Terlipressin was given until serum creatinine had decreased below 1.5 mg/dL (133 µmol/L) or for a maximum of 14 days.
In addition to terlipressin, all patients received albumin at a dose of 1g per kg body weight during the first 24 hours, followed by 40g daily,targeted to obtain a central venous pressure (CVP) between 10 and 15 cm of water.
| Study group | Role | What they receive |
|---|---|---|
| Terlipressin and albumin | Other | Single-group study (Type-1 Hepatorenal Syndrome Associated With Active Infections) Terlipressin was initially given at a dose of 1 mg/4h as an intravenous bolus for 2 days. If at day 3 serum creatinine had decreased at least 25% of the pretreatment values, the dose of terlipressin was not modified. In the remaining patients, the dose was increased up to a maximum of 2 mg/4h. Terlipressin was given until serum creatinine had decreased below 1.5 mg/dL (133 µmol/L) or for a maximum of 14 days. Receives: Drug: Terlipressin and albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum creatinine values
Measured: baseline and 14 days
Secondary outcomes (4)
changes in glomerular filtration rate
Measured: at 3 days and 14 days
Changes in arterial pressure
Measured: baseline to 14 days
changes in plasma renin activity
Measured: at 3 days and 14 days
changes in norepinephrine concentration
Measured: at 3 days and 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startDec 2012
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatorenal SyndromeStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pere Gines, Hospital Clinic of Barcelona
- Investigators
- Pere Ginès, MD, Principal investigator, Hospital Clinc of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932151
- Sponsor's protocol ID
- GIN-TER-2010-01
- Status last verified
- Sep 2013
- First submitted
- 14 Aug 2013
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Terlipressin and Albumin in Patients With Type-1 Hepatorenal Syndrome Associated With Sepsis
- ClinicalTrials.gov ID
- NCT01932151
- Acronym / sponsor ID
- GIN-TER-2010-01
- Conditions
- Hepatorenal Syndrome
- Keywords
- type-1 HRS, active bacterial infections, terlipressin and albumin, kidney function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 30 Aug 2013 (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.
Type 1 Hepatorenal syndrome (type-1 HRS) is a severe complication of patients with advanced cirrhosis characterized by marked renal failure and is associated with a very poor prognosis. Type-1 HRS is often precipitated by a bacterial infection, though it may occur spontaneously. It has been demonstrated that vasoconstrictor agents plus albumin are effective in the reversal of the renal failure. A large number of studies have shown that terlipressin improves renal function in patients with type 1 HRS; treatment is effective in 50-75% of patients approximately. Currently there are no specific studies about the treatment of type-1 HRS with ongoing infections.
Detailed description
All consecutive patients with cirrhosis hospitalized with an infection or who developed an infection during hospitalization for an acute decompensation of the disease in four university hospitals.
Criteria for inclusion were: 1/ cirrhosis as diagnosed by liver biopsy or a combination of clinical, biochemical, ultrasonographic, and/or endoscopic findings; 2/ age between 18 and 80 years; 3/ presence of sepsis, as defined by infection and signs of Systemic Inflammatory Response Syndrome; and 4/ occurrence of type-1 HRS during the infection, as defined by standard diagnostic criteria. Exclusion criteria were: 1/ hepatocellular carcinoma outside the Milan criteria; 2/ any severe extrahepatic condition, including cardiovascular, neurological, and organic kidney diseases; 3/ septic or hypovolemic shock; 4/ terminal condition (death expected in less than 48 hours); and 5/ lack of informed consent.
Aim: A proof of concept study to evaluate whether treatment with terlipressin and albumin in the course of an infection associated with type-1 HRS is effective and safe.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Terlipressin and albumin | Other | Drug: Terlipressin and albuminSingle-group study (Type-1 Hepatorenal Syndrome Associated With Active Infections) Terlipressin was initially given at a dose of 1 mg/4h as an intravenous bolus for 2 days. If at day 3 serum creatinine had decreased at least 25% of the pretreatment values, the dose of terlipressin was not modified. In the remaining patients, the dose was increased up to a maximum of 2 mg/4h. Terlipressin was given until serum creatinine had decreased below 1.5 mg/dL (133 µmol/L) or for a maximum of 14 days. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cirrhosis as diagnosed by liver biopsy or a combination of clinical, biochemical, ultrasonographic, and/or endoscopic findings.
- Age between 18 and 85 years.
- Presence of sepsis, as defined by active infection, and signs of Systemic Inflammatory Response Syndrome.
- Occurrence of type-1 HRS during the infection, as defined by standard diagnostic criteria.
Key exclusion criteria (5 listed)
- Hepatocellular carcinoma outside the Milan criteria.
- Any severe extrahepatic condition, including cardiovascular, neurological, and organic kidney diseases.
- Septic or hypovolemic shock.
- Terminal condition (death expected in less than 48 hours).
- Lack of informed consent.
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 |
|---|---|---|
| Terlipressin and albuminAlso: - Glypressyn, Ferring SA, Saint-Prex, Switzerland., - Albúmina Humana Grífols, Grífols , Barcelona, Spain.Single-group study (Type-1 Hepatorenal Syndrome Associated With Active Infections) Terlipressin was initially given at a dose of 1 mg/4h as an intravenous bolus for 2 days. If at day 3 serum creatinine had decreased at least 25% of the pretreatment values, the dose of terlipressin was not modified. In the remaining patients, the dose was increased up to a maximum of 2 mg/4h. Terlipressin was given until serum creatinine had decreased below 1.5 mg/dL (133 µmol/L) or for a maximum of 14 days. In addition to terlipressin, all patients received albumin at a dose of 1g per kg body weight during the first 24 hours, followed by 40g daily,targeted to obtain a central venous pressure (CVP) between 10 and 15 cm of water. | Drug | Terlipressin and albumin |
Primary outcome
Change in serum creatinine values
Time frame: baseline and 14 days
4 secondary outcomes
changes in glomerular filtration rate
Time frame: at 3 days and 14 days
Changes in arterial pressure
Time frame: baseline to 14 days
changes in plasma renin activity
Time frame: at 3 days and 14 days
changes in norepinephrine concentration
Time frame: at 3 days and 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 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.
Pere Ginès, MD principal investigator
Hospital Clinc of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Terlipressin and albumin in people with Hepatorenal Syndrome, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 5 Sep 2013. 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 Spain. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in serum creatinine values (time frame: baseline and 14 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 5 Sep 2013.