Heart InjuriesNCT06280898
Perioperative Factors and Early Postoperative Kidney Graft Function Recovery
An observational study of Heart Injuries and Kidney Transplant; Complications, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
Divided into two groups based on acute kidney injury: non-acute kidney injury group vs. non-acute kidney injury group. Acute kidney injury group, Acute Kidney Injury Network (AKIN), Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease (RIFLE), or Kidney Disease: Improving Global Outcomes… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Heart Injuries, Kidney Transplant; Complications
- What is being tested?
- Remote ischemic conditioning
- Type of treatment
- Surgery or procedure
- How many people
- 539 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2020to 14 Mar 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 19 or older who underwent kidney transplant surgery in the operating room of Seoul St. Mary's Hospital from January 1, 2016 to March 28, 2022.
Who may be able to join
- Adult patients aged 19 years or older who underwent kidney transplant surgery in the operating room
Who cannot join
- Pediatric patients under 19 years of age
- Patients with multiple organ transplants, including kidney transplants
- Patients undergoing re-kidney transplant surgery
- Patient examination findings missing from electronic medical record
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Perioperative Factors Affecting Early Postoperative Kidney Graft Function Recovery in Patients Undergoing Living Kidney Transplant Surgery
Divided into two groups based on acute kidney injury: non-acute kidney injury group vs. non-acute kidney injury group. Acute kidney injury group, Acute Kidney Injury Network (AKIN), Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease (RIFLE), or Kidney Disease: Improving Global Outcomes (KDIGO) I would like to divide it according to the definition. After testing the normal distribution of patients, donors, grafts, types of immunosuppressants, surgery/anesthesia factors, and blood test findings between the two groups through the Shapiro-Wilk test, continuous data was tested using the student t-test or Mann-Whitney U test. Sizes are compared using , and categorical data is compared with proportions using the χ2 test or Fisher's exact test. Analysis of factors related to acute kidney injury will be performed through univariate and multivariate logistic regression analysis.
- Conditions
- Heart Injuries, Kidney Transplant; Complications
- Being tested
- Remote ischemic conditioning
- Medical subject headings
- Heart Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningProcedure or surgery
Remote ischemic condition
| Study group | Role | What they receive |
|---|---|---|
| nonischemic | Not described | |
| ischemic | Not described Receives: Procedure: Remote ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin I
Troponin I difference in two groups
Measured: up to 24 hour postoperatively
Secondary outcomes (2)
Troponin T
Troponin T difference in two groups
Measured: up to 24 hour postoperatively
QTc interval
OTc interval difference in two groups
Measured: up to 24 hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 May 2020
- Primary completion14 Mar 2022
- Study completion14 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart InjuriesStudies 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
- 539 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Suk Chae, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280898
- Sponsor's protocol ID
- KC22RISI0395
- Status last verified
- Feb 2024
- First submitted
- 16 Feb 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Perioperative Factors Affecting Early Postoperative Kidney Graft Function Recovery in Patients Undergoing Living Kidney Transplant Surgery
- ClinicalTrials.gov ID
- NCT06280898
- Acronym / sponsor ID
- KC22RISI0395
- Conditions
- Heart Injuries, Kidney Transplant; Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 539 participants (actual)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 28 Feb 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.
Divided into two groups based on acute kidney injury: non-acute kidney injury group vs. non-acute kidney injury group. Acute kidney injury group, Acute Kidney Injury Network (AKIN), Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease (RIFLE), or Kidney Disease: Improving Global Outcomes (KDIGO) I would like to divide it according to the definition. After testing the normal distribution of patients, donors, grafts, types of immunosuppressants, surgery/anesthesia factors, and blood test findings between the two groups through the Shapiro-Wilk test, continuous data was tested using the student t-test or Mann-Whitney U test. Sizes are compared using , and categorical data is compared with proportions using the χ2 test or Fisher's exact test. Analysis of factors related to acute kidney injury will be performed through univariate and multivariate logistic regression analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nonischemic | – | – |
| ischemic | – | Procedure: Remote ischemic conditioning |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 19 or older who underwent kidney transplant surgery in the operating room of Seoul St. Mary's Hospital from January 1, 2016 to March 28, 2022.
Key inclusion criteria (1 listed)
- Adult patients aged 19 years or older who underwent kidney transplant surgery in the operating room
Key exclusion criteria (4 listed)
- Pediatric patients under 19 years of age
- Patients with multiple organ transplants, including kidney transplants
- Patients undergoing re-kidney transplant surgery
- Patient examination findings missing from electronic medical record
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 conditioningRemote ischemic condition | Procedure or surgery | ischemic |
Primary outcome
Troponin I
Time frame: up to 24 hour postoperatively
Troponin I difference in two groups
2 secondary outcomes
Troponin T
Time frame: up to 24 hour postoperatively
QTc interval
Time frame: up to 24 hour postoperatively
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 29 Feb 2024.
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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?
An observational study of Heart Injuries and Kidney Transplant; Complications, run by Seoul St. Mary's 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 4 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 29 Feb 2024. 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?
Troponin I (time frame: up to 24 hour postoperatively). 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 29 Feb 2024.