Liver Transplant DisorderNCT06312098
Perioperative Factors and Living Donor Liver Transplantation
An observational study of Liver Transplant Disorder, run by Min Suk Chae.
Trial summary
Liver transplant surgery is one of the treatments provided to patients suffering from end-stage liver disease, and has a successful treatment prognosis. However, it is clear that patient management before, during, and after surgery is a difficult task for medical staff due to the complex clinical and pathological… Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Liver Transplant Disorder
- What is being tested?
- remote ischemic preconditioning (RIPC)
- How many people
- 533 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Jul 2024
- 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 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data from adult patients undergoing elective living donor liver transplantation at Seoul St. Mary's Hospital were retrospectively collected with the electronic medical record system.
Who may be able to join
- adults
- elective surgery
- American Society of Anesthesiologists (ASA) physical status classification system I, II, III
Who cannot join
- American Society of Anesthesiologists (ASA) physical status classification system IV, V
About this study
Official title: The Study on Perioperative Factors Affecting Postoperative Outcomes in Patients Who Underwent Adult Liver Transplantation
Liver transplant surgery is one of the treatments provided to patients suffering from end-stage liver disease, and has a successful treatment prognosis. However, it is clear that patient management before, during, and after surgery is a difficult task for medical staff due to the complex clinical and pathological problems of end-stage liver disease. Moreover, the complex surgical technique of the liver transplant surgery itself and the severe hemodynamic fluctuations and multi-organ dysfunction that patients experience during the surgery have been shown to have a tremendous impact on the patient's prognosis after surgery.
A study on which clinical, laboratory, and hemodynamic factors experienced by patients during the perioperative period, including before, during, and after surgery, affect the survival rate of patients and transplanted organs. will definitely be helpful in the treatment of patients suffering from end-stage liver disease.
- Conditions
- Liver Transplant Disorder
- Being tested
- remote ischemic preconditioning (RIPC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischemic preconditioning (RIPC)Other
After induction of anesthesia, the paired RIPC group took the RIPC intervention on the upper arm in the lateral position. The RIPC intervention was applied using a manual cuff inflator, which consisted of three cycles of 5-min inflation of the blood pressure cuff (to 250 mmHg, or to 50 mmHg higher than the preoperative SBP), followed by 5-min deflation of the cuff. In the no-RIPC group, a blood pressure cuff was also applied on the upper arm but was not inflated.
| Study group | Role | What they receive |
|---|---|---|
| no-remote ischemic preconditioning group | patients who did not receive remote ischemic preconditioning | |
| paired remote ischemic preconditioning group | patients who receive remote ischemic preconditioning Receives: Other: remote ischemic preconditioning (RIPC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postreperfusion syndrome
mean blood pressure decreases by 30% based on the value on preoperative day
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 533 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min Suk Chae
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Min Suk Chae, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312098
- Sponsor's protocol ID
- KC21RISI0576
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or analyzed during this study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study on Perioperative Factors Affecting Postoperative Outcomes in Patients Who Underwent Adult Liver Transplantation
- ClinicalTrials.gov ID
- NCT06312098
- Acronym / sponsor ID
- KC21RISI0576
- Conditions
- Liver Transplant Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 533 participants (estimated)
- Lead sponsor
- Min Suk ChaeUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 15 Mar 2024 (actual)
- 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.
Liver transplant surgery is one of the treatments provided to patients suffering from end-stage liver disease, and has a successful treatment prognosis. However, it is clear that patient management before, during, and after surgery is a difficult task for medical staff due to the complex clinical and pathological problems of end-stage liver disease. Moreover, the complex surgical technique of the liver transplant surgery itself and the severe hemodynamic fluctuations and multi-organ dysfunction that patients experience during the surgery have been shown to have a tremendous impact on the patient's prognosis after surgery.
A study on which clinical, laboratory, and hemodynamic factors experienced by patients during the perioperative period, including before, during, and after surgery, affect the survival rate of patients and transplanted organs. will definitely be helpful in the treatment of patients suffering from end-stage liver disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no-remote ischemic preconditioning group | – | –patients who did not receive remote ischemic preconditioning |
| paired remote ischemic preconditioning group | – | Other: remote ischemic preconditioning (RIPC)patients who receive remote ischemic preconditioning |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data from adult patients undergoing elective living donor liver transplantation at Seoul St. Mary's Hospital were retrospectively collected with the electronic medical record system.
Key inclusion criteria (3 listed)
- adults
- elective surgery
- American Society of Anesthesiologists (ASA) physical status classification system I, II, III
Key exclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status classification system IV, V
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 |
|---|---|---|
| remote ischemic preconditioning (RIPC)After induction of anesthesia, the paired RIPC group took the RIPC intervention on the upper arm in the lateral position. The RIPC intervention was applied using a manual cuff inflator, which consisted of three cycles of 5-min inflation of the blood pressure cuff (to 250 mmHg, or to 50 mmHg higher than the preoperative SBP), followed by 5-min deflation of the cuff. In the no-RIPC group, a blood pressure cuff was also applied on the upper arm but was not inflated. | Other | paired remote ischemic preconditioning group |
Primary outcome
Incidence of postreperfusion syndrome
Time frame: during surgery
mean blood pressure decreases by 30% based on the value on preoperative day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: No. The datasets used and/or analyzed during this study are available from the corresponding author on reasonable request.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant Disorder, run by Min Suk Chae.
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 3 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 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Incidence of postreperfusion syndrome (time frame: during surgery). 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 18 Mar 2024.