Patients With Postoperative Mechanical Ventilation After Liver TransplantationNCT02402634
Inflammatory Gene Polymorphism and Prolonged Mechanical Ventilation After Liver Transplantation
An observational study of Patients With Postoperative Mechanical Ventilation After Liver Transplantation, run by Yonsei University at 1 site in South Korea.
Trial summary
Mechanical ventilatory lung care is essential for postoperative care in liver transplantation recipients, for such patients are under massive fluid challenge and hemodynamic alterations perioperatively. Some of the recipients experience difficulty in weaning off from the mechanical ventilator due to various causes. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Patients With Postoperative Mechanical Ventilation After Liver Transplantation
- What is being tested?
- Mechanical ventilatory lung care
- How many people
- 141 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2015to 8 Jan 2018
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 20-65 years old, scheduled for liver transplantation.
Who may be able to join
- 20-65 years old
- scheduled for liver transplantation
Who cannot join
- Patients under mechanical ventilation prior to surgery
- patients with muscular skeletal disorder, probable cause for respiratory depression
- patients not able to read, or understand the consent form
- ethnicity, other than asian
- patients refusal
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 120-752
About this study
Mechanical ventilatory lung care is essential for postoperative care in liver transplantation recipients, for such patients are under massive fluid challenge and hemodynamic alterations perioperatively. Some of the recipients experience difficulty in weaning off from the mechanical ventilator due to various causes. This study is to investigate the relationship between the inflammatory gene polymorphism, known for acute lung injury, and the duration of mechanical ventilatory care for such liver transplantation recipients.
- Being tested
- Mechanical ventilatory lung care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilatory lung careOther
| Study group | Role | What they receive |
|---|---|---|
| Mechanical ventilatory lung care | liver transplantation recipients under mechanical ventilatory lung care Receives: Other: Mechanical ventilatory lung care |
What is being measured
The primary outcome is the main question the study is designed to answer.
total duration of postoperative ventilator care
Time for successful weaning from ventilator could correlate with the inflammtory gene polymorphism, especially those related to acute lung injury.
Measured: an expected average of 2-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startJan 2015
- Primary completion8 Jan 2018
- Study completion8 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Postoperative Mechanical Ventilation After Liver TransplantationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 141 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
- NCT02402634
- Sponsor's protocol ID
- 4-2014-0989
- Status last verified
- Feb 2019
- First submitted
- 25 Mar 2015
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Gene Polymorphism and Prolonged Mechanical Ventilation After Liver Transplantation
- ClinicalTrials.gov ID
- NCT02402634
- Acronym / sponsor ID
- 4-2014-0989
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 8 Jan 2018 (actual)
- First posted
- 30 Mar 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.
Mechanical ventilatory lung care is essential for postoperative care in liver transplantation recipients, for such patients are under massive fluid challenge and hemodynamic alterations perioperatively. Some of the recipients experience difficulty in weaning off from the mechanical ventilator due to various causes. This study is to investigate the relationship between the inflammatory gene polymorphism, known for acute lung injury, and the duration of mechanical ventilatory care for such liver transplantation recipients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanical ventilatory lung care | – | Other: Mechanical ventilatory lung careliver transplantation recipients under mechanical ventilatory lung care |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 20-65 years old, scheduled for liver transplantation.
Key inclusion criteria (2 listed)
- 20-65 years old
- scheduled for liver transplantation
Key exclusion criteria (5 listed)
- Patients under mechanical ventilation prior to surgery
- patients with muscular skeletal disorder, probable cause for respiratory depression
- patients not able to read, or understand the consent form
- ethnicity, other than asian
- patients refusal
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 |
|---|---|---|
| Mechanical ventilatory lung care | Other | Mechanical ventilatory lung care |
Primary outcome
total duration of postoperative ventilator care
Time frame: an expected average of 2-3 days
Time for successful weaning from ventilator could correlate with the inflammtory gene polymorphism, especially those related to acute lung injury.
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 15 Feb 2019.
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?
An observational study of Patients With Postoperative Mechanical Ventilation After Liver Transplantation, 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 2 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 15 Feb 2019. 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.
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?
total duration of postoperative ventilator care (time frame: an expected average of 2-3 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 15 Feb 2019.