Post-transplantation Liver Allograft FunctionPhase 4NCT02341833
Effects of Preconditioning With Sevoflurane During Organ Procurement From Brain Dead Donors: Impact on Early Function of Liver Allografts
A Phase 4 study testing Sevoflurane in people with Post-transplantation Liver Allograft Function, run by University of Liege at 1 site in Belgium.
Trial summary
The aim of the investigators study is to investigate the effects of anaesthetic preconditioning with sevoflurane during organs harvesting in brain dead donors. More particularly, the investigators will investigate whether sevoflurane preconditioning protects against ischaemia-reperfusion the livers and kidneys… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post-transplantation Liver Allograft Function
- What is being tested?
- Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2015to Dec 2017
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all consecutive brain dead donors in the Belgian university hospitals of Leuven, Brussels, Louvain and Liège eligible for organs harvesting followed by organs transplantation in the Eurotransplant area. There is no age limitation for eligibility
Who cannot join
- haemodynamic instability that precludes safe administration of 2% sevoflurane.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Department of Anesthesiology, CHU Liège
Liège, B-4000
Jean L Joris, MD, PhD, 32-4-3667180, jean.joris@chu.ulg.ac.be
Gregory G Minguet, MD
About this study
The aim of the investigators study is to investigate the effects of anaesthetic preconditioning with sevoflurane during organs harvesting in brain dead donors. More particularly, the investigators will investigate whether sevoflurane preconditioning protects against ischaemia-reperfusion the livers and kidneys allografts after a prolonged period of cold ischaemia and whether this protection translates in a better clinical functional recovery of these allografts.
- Being tested
- Sevoflurane
- Keywords
- Anesthetic preconditioning, Sevoflurane, Liver transplantation, brain-death donors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
In the sevoflurane group, the anesthetic agent has to be administered immediately after arrival in the operating room to reach an end-expiratory target concentration of 2%. This concentration of sevoflurane should be maintained until the procedural cardiac arrest and for at least 15 min.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Active comparator | 1 MAC of sevoflurane for 15 minutes before organs procurement. Receives: Drug: Sevoflurane |
| No intervention | No intervention | No volatile anesthetics during organs procurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome of liver function following liver transplantation.
- Transaminases, bilirubin, prothrombin time (PT) and international normalized ratio (INR) on the first post-transplantation blood test and on the following samples from the 1st to the 7th postoperative days.
- Number of liver recipients that will meet the criteria for "early allograft dysfunction" as defined by :
- bilirubin ≥10 mg/dL on the 7th day.
- INR ≥ 1.6 on the 7th day.
- ALAT or ASAT > 2000 UI/L during the first 7 postoperative days.
Measured: First week post-transplantation
Secondary outcomes (4)
• Incidence of primary non function (liver failure requiring emergent re-transplantation)
Measured: 30-day and 6-month after transplantation.
• Hospital length of stay.
Measured: 30-day and 6-month after transplantation.
• Allograft function (yes/no) at 30-day and 6-month after transplantation.
Measured: 30-day and 6-month after transplantation.
• Hospital mortality and at 30-day.
Measured: 30-day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-transplantation Liver Allograft FunctionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Minguet, University of Liege
- Investigators
- Jean L Joris, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341833
- Sponsor's protocol ID
- 2014-26-06
- Status last verified
- Jan 2015
- First submitted
- 26 Jun 2014
- Last updated
- 21 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preconditioning With Sevoflurane During Organ Procurement From Brain Dead Donors: Impact on Early Function of Liver Allografts
- ClinicalTrials.gov ID
- NCT02341833
- Acronym / sponsor ID
- 2014-26-06
- Keywords
- Anesthetic preconditioning, Sevoflurane, Liver transplantation, brain-death donors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (estimated)
- First posted
- 19 Jan 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 aim of the investigators study is to investigate the effects of anaesthetic preconditioning with sevoflurane during organs harvesting in brain dead donors. More particularly, the investigators will investigate whether sevoflurane preconditioning protects against ischaemia-reperfusion the livers and kidneys allografts after a prolonged period of cold ischaemia and whether this protection translates in a better clinical functional recovery of these allografts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Active comparator | Drug: Sevoflurane1 MAC of sevoflurane for 15 minutes before organs procurement. |
| No intervention | No intervention | –No volatile anesthetics during organs procurement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all consecutive brain dead donors in the Belgian university hospitals of Leuven, Brussels, Louvain and Liège eligible for organs harvesting followed by organs transplantation in the Eurotransplant area. There is no age limitation for eligibility
Key exclusion criteria (1 listed)
- haemodynamic instability that precludes safe administration of 2% sevoflurane.
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 |
|---|---|---|
| SevofluraneIn the sevoflurane group, the anesthetic agent has to be administered immediately after arrival in the operating room to reach an end-expiratory target concentration of 2%. This concentration of sevoflurane should be maintained until the procedural cardiac arrest and for at least 15 min. | Drug | Sevoflurane |
Primary outcome
Composite outcome of liver function following liver transplantation.
Time frame: First week post-transplantation
* Transaminases, bilirubin, prothrombin time (PT) and international normalized ratio (INR) on the first post-transplantation blood test and on the following samples from the 1st to the 7th postoperative days. * Number of liver recipients that will meet the criteria for "early allograft dysfunction" as defined by : * bilirubin ≥10 mg/dL on the 7th day. * INR ≥ 1.6 on the 7th day. * ALAT or ASAT > 2000 UI/L during the first 7 postoperative days.
4 secondary outcomes
• Incidence of primary non function (liver failure requiring emergent re-transplantation)
Time frame: 30-day and 6-month after transplantation.
• Hospital length of stay.
Time frame: 30-day and 6-month after transplantation.
• Allograft function (yes/no) at 30-day and 6-month after transplantation.
Time frame: 30-day and 6-month after transplantation.
• Hospital mortality and at 30-day.
Time frame: 30-day.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2015.
- Department of Anesthesiology, CHU Liège, BelgiumLink provided by the sponsor.
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.
Jean L Joris, MD, PhD principal investigator
Centre Hospitalier Universitaire de Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevoflurane in people with Post-transplantation Liver Allograft Function, run by University of Liege at 1 site in Belgium.
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 1 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 21 Jan 2015. 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 Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Jean L Joris, MD, PhD (32-4-3667180, jean.joris@chu.ulg.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome of liver function following liver transplantation. (time frame: First week post-transplantation). 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 21 Jan 2015.