Liver TransplantationPhase 4NCT01886664
Comparison of PRS According to Inhalation Agent During LDLT
A Phase 4 study testing sevoflurane and Desflurane in people with Liver Transplantation and Postreperfusion Syndrome, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators tried to evaluate the effect of desflurane on the incidence of postreperfusion syndrome during living donor liver transplantation surgery. The investigators used sevoflurane as a comparison. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplantation, Postreperfusion Syndrome
- What is being tested?
- sevoflurane and Desflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to Dec 2013
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective LDLT
Who cannot join
- age < 18, age > 65
- patient refusal
- re-transplantation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 110-744
About this study
The investigators tried to evaluate the effect of desflurane on the incidence of postreperfusion syndrome during living donor liver transplantation surgery. The investigators used sevoflurane as a comparison.
- Conditions
- Liver Transplantation, Postreperfusion Syndrome
- Being tested
- sevoflurane, Desflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sevofluraneDrug
DesfluraneDrug
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Active comparator | Performing liver transplantation under general anesthesia using sevoflurane Receives: Drug: sevoflurane |
| Desflurane | Experimental | Performing liver transplantation under general anesthesia using desflurane Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of PRS
reperfusion syndrome occurs, if it occurs, immediately after reperfusion. Therefore, the primary outcome, reperfusion syndrome, can only be assessed immediately after reperfusion.
Measured: immediately after reperfusion
Secondary outcomes (1)
ICU length of stay
Measured: after LT until the patient is transferred to the ward
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startDec 2012
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886664
- Sponsor's protocol ID
- Des vs Sevo PRS
- Status last verified
- Jun 2014
- First submitted
- 20 Aug 2012
- Last updated
- 26 Jun 2014
- Results posted
- No
Publications
Lee J, Yoo YJ, Lee JM, Park YJ, Ryu HG. Sevoflurane Versus Desflurane on the Incidence of Postreperfusion Syndrome During Living Donor Liver Transplantation: A Randomized Controlled Trial. Transplantation. 2016 Mar;100(3):600-6. doi: 10.1097/TP.0000000000000874.
PubMed 26335917
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of PRS According to Inhalation Agent During LDLT
- ClinicalTrials.gov ID
- NCT01886664
- Acronym / sponsor ID
- Des vs Sevo PRS
- Conditions
- Liver Transplantation, Postreperfusion Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Jun 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.
The investigators tried to evaluate the effect of desflurane on the incidence of postreperfusion syndrome during living donor liver transplantation surgery. The investigators used sevoflurane as a comparison.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Active comparator | Drug: sevofluranePerforming liver transplantation under general anesthesia using sevoflurane |
| Desflurane | Experimental | Drug: DesfluranePerforming liver transplantation under general anesthesia using desflurane |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective LDLT
Key exclusion criteria (3 listed)
- age < 18, age > 65
- patient refusal
- re-transplantation
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 |
|---|---|---|
| sevoflurane | Drug | Sevoflurane |
| Desflurane | Drug | Desflurane |
Primary outcome
frequency of PRS
Time frame: immediately after reperfusion
reperfusion syndrome occurs, if it occurs, immediately after reperfusion. Therefore, the primary outcome, reperfusion syndrome, can only be assessed immediately after reperfusion.
1 secondary outcome
ICU length of stay
Time frame: after LT until the patient is transferred to the ward
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 26 Jun 2014.
- Derived from this study: PubMed 26335917Lee J, Yoo YJ, Lee JM, Park YJ, Ryu HG. Sevoflurane Versus Desflurane on the Incidence of Postreperfusion Syndrome During Living Donor Liver Transplantation: A Randomized Controlled Trial. Transplantation. 2016 Mar;100(3):600-6. doi: 10.1097/TP.0000000000000874.
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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.
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 and Desflurane in people with Liver Transplantation and Postreperfusion Syndrome, run by Seoul National University Hospital at 1 site in South Korea.
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 3 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 26 Jun 2014. 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 South Korea. 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?
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?
frequency of PRS (time frame: immediately after reperfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01886664, which also lists 1 linked publication.
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 26 Jun 2014.