Patients Undergoing Lung Transplantation Under Extracorporeal Membrane OxygenationPhase 4NCT02009280
A Comparison of Propofol Based Total Intravenous Anesthesia and Sevoflurane Based Balanced Anesthesia on Renal Protection During Lung Transplantation Under Extracorporeal Membrane Oxygenation - A Prospective, Randomized Trial
A Phase 4 study testing Administration of anesthesia: Propofol and Administration of anesthesia: Sevoflurane in people with Patients Undergoing Lung Transplantation Under Extracorporeal Membrane Oxygenation, run by Yonsei University at 1 site in South Korea.
Trial summary
The aim of this study is to investigate whether propofol based total intravenous anesthesia reduces incidence of acute kidney injury following the lung transplantation under extracorporeal membrane oxygenation Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Patients Undergoing Lung Transplantation Under Extracorporeal Membrane Oxygenation
- What is being tested?
- Administration of anesthesia: Propofol and Administration of anesthesia: Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to Jul 2016
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sixty adults undergoing lung transplantation under extracorporeal membrane oxygenation
Who cannot join
- Patient having propofol allergy, BMI > 30 kg/m2
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System
Seoul, 120-752
About this study
The aim of this study is to investigate whether propofol based total intravenous anesthesia reduces incidence of acute kidney injury following the lung transplantation under extracorporeal membrane oxygenation
- Being tested
- Administration of anesthesia: Propofol, Administration of anesthesia: Sevoflurane
- Keywords
- Propofol, Lung transplantation, Extracorporeal membrane oxygenation, Acute kidney injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of anesthesia: PropofolDrug
Maintenance of anesthesia with the propofol
Administration of anesthesia: SevofluraneDrug
Maintenance of anesthesia with the sevoflurane
| Study group | Role | What they receive |
|---|---|---|
| Propofol group | Experimental | Propofol group Receives: Drug: Administration of anesthesia: Propofol |
| Sevoflurane group | Active comparator | Sevoflurane group Receives: Drug: Administration of anesthesia: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the incidence of acute kidney injury between the lung transplantation recipients under propofol based anesthesia and inhalation based anesthesia
Developement of the acute kidney injury is determined by Plasma neutrophil gelatinase-associated lipocalin (NGAL), Cystatin C, and Creatinine
Measured: Postoperative 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Lung Transplantation Under Extracorporeal Membrane OxygenationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009280
- Sponsor's protocol ID
- 4-2013-0648
- Status last verified
- Aug 2016
- First submitted
- 8 Dec 2013
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Propofol Based Total Intravenous Anesthesia and Sevoflurane Based Balanced Anesthesia on Renal Protection During Lung Transplantation Under Extracorporeal Membrane Oxygenation - A Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT02009280
- Acronym / sponsor ID
- 4-2013-0648
- Keywords
- Propofol, Lung transplantation, Extracorporeal membrane oxygenation, Acute kidney injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 11 Dec 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 aim of this study is to investigate whether propofol based total intravenous anesthesia reduces incidence of acute kidney injury following the lung transplantation under extracorporeal membrane oxygenation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol group | Experimental | Drug: Administration of anesthesia: PropofolPropofol group |
| Sevoflurane group | Active comparator | Drug: Administration of anesthesia: SevofluraneSevoflurane group |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Sixty adults undergoing lung transplantation under extracorporeal membrane oxygenation
Key exclusion criteria (1 listed)
- Patient having propofol allergy, BMI > 30 kg/m2
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 |
|---|---|---|
| Administration of anesthesia: PropofolMaintenance of anesthesia with the propofol | Drug | Propofol group |
| Administration of anesthesia: SevofluraneMaintenance of anesthesia with the sevoflurane | Drug | Sevoflurane group |
Primary outcome
Comparison of the incidence of acute kidney injury between the lung transplantation recipients under propofol based anesthesia and inhalation based anesthesia
Time frame: Postoperative 48 hours
Developement of the acute kidney injury is determined by Plasma neutrophil gelatinase-associated lipocalin (NGAL), Cystatin C, and Creatinine
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 17 Aug 2016.
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 Administration of anesthesia: Propofol and Administration of anesthesia: Sevoflurane in people with Patients Undergoing Lung Transplantation Under Extracorporeal Membrane Oxygenation, run by Yonsei University 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 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: finished, as of the sponsor's last update on 17 Aug 2016. 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?
Comparison of the incidence of acute kidney injury between the lung transplantation recipients under propofol based anesthesia and inhalation based anesthesia (time frame: Postoperative 48 hours). 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 17 Aug 2016.