Kidney FailurePhase 2TIROLNCT02368249
Does Terlipressin Improve Renal Outcome After Liver Surgery
A Phase 2 study testing Terlipressin in people with Kidney Failure, run by University of Zurich at 1 site in Switzerland.
Trial summary
The investigators aim to address whether terlipressin improves the renal outcome after liver surgery. Therefore the investigators are planning to conduct a double-blinded randomized control trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure
- What is being tested?
- Terlipressin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2020to Feb 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >=12% risk for post-operative ARF on our recently developed and validated prediction score for ARF after liver surgery, patients will need five points or more in the pre-operative assessment of the predictors to be enrolled in the trial
Who cannot join
- < 18 years
- liver cirrhosis
- coronary insufficiency with ST-elevation or ST-depression in the - - intra-operative ECG as signs of an acute coronary syndrome
- pregnancy and breast feed
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Visceral and Transplantation Surgery of the University Hospital of Zurich
Zurich, 8091
About this study
Official title: Does Terlipressin Improve Renal Outcome After Liver Surgery - A Double-Blinded Randomized Control Trial (TIROL-Trial)
The investigators aim to address whether terlipressin improves the renal outcome after liver surgery. Therefore the investigators are planning to conduct a double-blinded randomized control trial. The investigators will randomize patients undergoing any kind of liver surgery and being at increased moderate to high risk for post-operative acute renal failure into a control group receiving post- operative a placebo or into a group receiving post-operatively terlipressin in combination with human albumin.
- Conditions
- Kidney Failure
- Being tested
- Terlipressin, Placebo
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerlipressinDrug
Also called Gylpressin
Patients are receiving a post-operative intravenous terlipressin treatment in association with human albumin to preserve the renal function
PlaceboDrug
Also called Ringer's lactate solution
Patients are receiving a post-operative intravenous Ringer's lactate solution
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Patients receiving post-operative placebo (Ringer lactate solution) treatment to preserve the renal function Receives: Drug: Placebo |
| Terlipressin Group | Experimental | Patients receiving a post-operative intravenous terlipressin treatment in association with human albumin to preserve the renal function Receives: Drug: Terlipressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum creatinine peak level within 48 hours post-operative
Measured: within 48 hours post-operative
Secondary outcomes (6)
the urinary output/24h
Measured: Post Operative Day 0 to 3
Need for hemofiltration and/or hemodialysis
participants will be followed for the duration of hospital stay, an expected average of 14 days
Measured: Post Operative Day 0 - 14
Morbidity & mortality
measured by the comprehensive complication index; participants will be followed for the duration of hospital stay, an expected average of 14 days
Measured: Post Operative Day 0 - 14
Liver function
assessed by serum levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
Measured: Post Operative Day 0 - 5
length of hospital stay
in days; participants will be followed for the duration of hospital stay, an expected average of 14 days
Measured: Post Operative Day 0 - 14
length of ICU stay
in days; participants will be followed for the duration of ICU stay, an expected average of 7 days
Measured: Post Operative Day 0 - 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startJan 2020 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Why it stopped: no focus on this topic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ksenija Slankamenac, University of Zurich
- Investigators
- Pierre-Alain Clavien, MD PhD, Study director, Departement of Visceral and Transplantation Surgery Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368249
- Sponsor's protocol ID
- 2012-0581
- Acronym
- TIROL
- Status last verified
- May 2017
- First submitted
- 9 Feb 2015
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Terlipressin Improve Renal Outcome After Liver Surgery - A Double-Blinded Randomized Control Trial (TIROL-Trial)
- ClinicalTrials.gov ID
- NCT02368249
- Acronym / sponsor ID
- TIROL / 2012-0581
- Conditions
- Kidney Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no focus on this topic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 23 Feb 2015 (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.
The investigators aim to address whether terlipressin improves the renal outcome after liver surgery. Therefore the investigators are planning to conduct a double-blinded randomized control trial. The investigators will randomize patients undergoing any kind of liver surgery and being at increased moderate to high risk for post-operative acute renal failure into a control group receiving post- operative a placebo or into a group receiving post-operatively terlipressin in combination with human albumin.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Drug: PlaceboPatients receiving post-operative placebo (Ringer lactate solution) treatment to preserve the renal function |
| Terlipressin Group | Experimental | Drug: TerlipressinPatients receiving a post-operative intravenous terlipressin treatment in association with human albumin to preserve the renal function |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- >=12% risk for post-operative ARF on our recently developed and validated prediction score for ARF after liver surgery, patients will need five points or more in the pre-operative assessment of the predictors to be enrolled in the trial
Key exclusion criteria (4 listed)
- < 18 years
- liver cirrhosis
- coronary insufficiency with ST-elevation or ST-depression in the - - intra-operative ECG as signs of an acute coronary syndrome
- pregnancy and breast feed
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 |
|---|---|---|
| TerlipressinAlso: GylpressinPatients are receiving a post-operative intravenous terlipressin treatment in association with human albumin to preserve the renal function | Drug | Terlipressin Group |
| PlaceboAlso: Ringer's lactate solutionPatients are receiving a post-operative intravenous Ringer's lactate solution | Drug | Control Group |
Primary outcome
serum creatinine peak level within 48 hours post-operative
Time frame: within 48 hours post-operative
6 secondary outcomes
the urinary output/24h
Time frame: Post Operative Day 0 to 3
Need for hemofiltration and/or hemodialysis
Time frame: Post Operative Day 0 - 14
Morbidity & mortality
Time frame: Post Operative Day 0 - 14
Liver function
Time frame: Post Operative Day 0 - 5
length of hospital stay
Time frame: Post Operative Day 0 - 14
length of ICU stay
Time frame: Post Operative Day 0 - 7
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
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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.
Pierre-Alain Clavien, MD PhD study director
Departement of Visceral and Transplantation Surgery Zurich
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 Terlipressin in people with Kidney Failure, run by University of Zurich at 1 site 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 1 inclusion and 4 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: withdrawn, as of the sponsor's last update on 5 May 2017. 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 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
serum creatinine peak level within 48 hours post-operative (time frame: within 48 hours post-operative). 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 May 2017.