Acute Kidney InjuryNCT06320730
Impact of Glycemic Control After Reperfusion on Acute Kidney Injury in Living Donor Liver Transplantation
An observational study of Acute Kidney Injury and Hyperglycemia, run by Asan Medical Center at 1 site in South Korea.
Trial summary
This retrospective cohort study of patients classified by the blood glucose level after reperfusion in liver transplantation repicient. Our object is to investigate whether controlling BG levels within the optimal range during neohepatic phase is associated with a reduction of AKI incidence. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Kidney Injury, Hyperglycemia, Hypoglycemia
- What is being tested?
- Observational study, records of blood glucose level after reperfusion
- How many people
- 3,790 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Aug 2020to 1 Mar 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: living donor liver transplant recipients at Asan Medical Center, Seoul, Korea, Republic of Korea, from January 2008 to December 2019.
Who may be able to join
- Living donor liver transplantation recipients
Who cannot join
- The exclusion criteria were as follows: recipients under 18 years old, recipients who had undergone deceased donor liver transplantation, recipients who had undergone re-transplantation, recipients with impaired renal function such as CKD or HRS, or those with insufficient data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Glycemic Control After Reperfusion on Acute Kidney Injury in Living Donor Liver Transplantation: A Propensity Score-matched Analysis
This retrospective cohort study of patients classified by the blood glucose level after reperfusion in liver transplantation repicient. Our object is to investigate whether controlling BG levels within the optimal range during neohepatic phase is associated with a reduction of AKI incidence. Furthermore, severe AKI, chronic kidney disease (CKD), major adverse cardiac event (MACE) and mortality were also investigated.
Read the detailed description
The detrimental impact of glucose instability including hyper- and hypoglycemia on postoperative outcomes has been well-established in various fields, particularly in cardiac surgery, and intensive care unit settings. Also, glucose instability occurs frequently in liver transplantation (LT) surgery, attributed to factors such as insulin resistance, surgical stress, and onset of gluconeogenesis after reperfusion of the newly transplanted graft. Previous reports have demonstrated that hyperglycemia is associated with increased mortality, a higher incidence of graft rejection, and surgical site infection in LT. Alongside hyperglycemia, it is also important to consider hypoglycemia, given its association with adverse outcomes.
Acute kidney injury (AKI) stands as one of the most common and critical complications following LT, impacting extended duration of hospital stay, increased morbidity, and mortality. Although the etiology of AKI after LT is multifactorial, perioperative hyper- and hypoglycemia have also been suggested as potential risk factors for postoperative AKI. However, a recent study only has demonstrated that increased glucose variability, rather than hyper-and hypoglycemia alone, is associated with postoperative AKI after LT. The contradictory results observed to date may be attributed to differences in the definition of hyperglycemia, reflecting the challenges in determining the optimal blood glucose (BG) level in LT. In our study, the optimal BG level was determined according to the most recently updated and professional guidelines on glycemic control.
Identifying the timing for glycemic control during LT is also as crucial as determining the optimal BG level. BG levels reach their peak in the neohepatic phase and begin to decrease 3 hours after reperfusion. This excessively elevated hyperglycemia is due to glucose influx from the grafted liver, in addition to peripheral insulin resistance, and gradually decreases after successful LT. Therefore, maintaining a well-controlled BG level within the optimal range, especially during the neohepatic phase, may be associated with better outcomes after transplantation.
Our object is to investigate whether controlling BG levels within the optimal range during neohepatic phase is associated with a reduction of AKI incidence. Furthermore, severe AKI, chronic kidney disease (CKD), major adverse cardiac event (MACE), and mortality were also investigated.
- Being tested
- Observational study, records of blood glucose level after reperfusion
- Medical subject headings
- Acute Kidney Injury, Hyperglycemia, Hypoglycemia, End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study, records of blood glucose level after reperfusionOther
Analyzes blood glucose level after reperfusion by dividing it into two groups: those with blood glucose levels between 110 and 180 and those with blood glucose levels below 110 or above 180.
| Study group | Role | What they receive |
|---|---|---|
| Group 110 < REP BG < 180 | Those with blood glucose levels over 110 and under 180 after reperfusion in liver transplantation recipients. Receives: Other: Observational study, records of blood glucose level after reperfusion | |
| Group REP BG ≤110 or ≥180 | Those with blood glucose levels below 110 or above 180 after reperfusion in liver transplantation recipients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of acute kidney injury
determined by change in sCr according to the Kidney Disease: Improving Global Outcomes (KDIGO) definition (increase in sCr of ≥26.5 mmol litre-1 within 48h or ≥1.5 times baseline within 7 days after surgery)
Measured: within 7 days after surgery
Secondary outcomes (4)
incidence of severe AKI
Severe AKI was defined as KIDIGO stage 2 or 3
Measured: within 7 days after surgery
incidence of chronic kidney disease (CKD)
when renal function assessed by calculating estimated serum glomerular filtration using the abbreviated modification of diet in renal disease equation was <60 mL/min/1.73 m2 for 3 months or more, irrespective of cause
Measured: within 1 year after surgery
incidence of Major adverse cardiac event (MACE)
MACE was defined including myocardial infarction (MI), atrial fibrillation (AF), pulmonary thromboembolism (PTE), heart failure (HF), cardiac arrest, and/or stroke
Measured: within postoperative 30 days (POD30)
overall mortality
overall mortality
Measured: the mortality at overall period (calculated from the date of surgery to the last follow-up) from the date of surgery (up to 10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start25 Aug 2020
- Primary completion29 Aug 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,790 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun-Gol Song, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320730
- Sponsor's protocol ID
- 2020-0675
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Glycemic Control After Reperfusion on Acute Kidney Injury in Living Donor Liver Transplantation: A Propensity Score-matched Analysis
- ClinicalTrials.gov ID
- NCT06320730
- Acronym / sponsor ID
- 2020-0675
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,790 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 29 Aug 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 20 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.
This retrospective cohort study of patients classified by the blood glucose level after reperfusion in liver transplantation repicient. Our object is to investigate whether controlling BG levels within the optimal range during neohepatic phase is associated with a reduction of AKI incidence. Furthermore, severe AKI, chronic kidney disease (CKD), major adverse cardiac event (MACE) and mortality were also investigated.
Detailed description
The detrimental impact of glucose instability including hyper- and hypoglycemia on postoperative outcomes has been well-established in various fields, particularly in cardiac surgery, and intensive care unit settings. Also, glucose instability occurs frequently in liver transplantation (LT) surgery, attributed to factors such as insulin resistance, surgical stress, and onset of gluconeogenesis after reperfusion of the newly transplanted graft. Previous reports have demonstrated that hyperglycemia is associated with increased mortality, a higher incidence of graft rejection, and surgical site infection in LT. Alongside hyperglycemia, it is also important to consider hypoglycemia, given its association with adverse outcomes.
Acute kidney injury (AKI) stands as one of the most common and critical complications following LT, impacting extended duration of hospital stay, increased morbidity, and mortality. Although the etiology of AKI after LT is multifactorial, perioperative hyper- and hypoglycemia have also been suggested as potential risk factors for postoperative AKI. However, a recent study only has demonstrated that increased glucose variability, rather than hyper-and hypoglycemia alone, is associated with postoperative AKI after LT. The contradictory results observed to date may be attributed to differences in the definition of hyperglycemia, reflecting the challenges in determining the optimal blood glucose (BG) level in LT. In our study, the optimal BG level was determined according to the most recently updated and professional guidelines on glycemic control.
Identifying the timing for glycemic control during LT is also as crucial as determining the optimal BG level. BG levels reach their peak in the neohepatic phase and begin to decrease 3 hours after reperfusion. This excessively elevated hyperglycemia is due to glucose influx from the grafted liver, in addition to peripheral insulin resistance, and gradually decreases after successful LT. Therefore, maintaining a well-controlled BG level within the optimal range, especially during the neohepatic phase, may be associated with better outcomes after transplantation.
Our object is to investigate whether controlling BG levels within the optimal range during neohepatic phase is associated with a reduction of AKI incidence. Furthermore, severe AKI, chronic kidney disease (CKD), major adverse cardiac event (MACE), and mortality were also investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 110 < REP BG < 180 | – | Other: Observational study, records of blood glucose level after reperfusionThose with blood glucose levels over 110 and under 180 after reperfusion in liver transplantation recipients. |
| Group REP BG ≤110 or ≥180 | – | –Those with blood glucose levels below 110 or above 180 after reperfusion in liver transplantation recipients. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- living donor liver transplant recipients at Asan Medical Center, Seoul, Korea, Republic of Korea, from January 2008 to December 2019.
Key inclusion criteria (1 listed)
- Living donor liver transplantation recipients
Key exclusion criteria (1 listed)
- The exclusion criteria were as follows: recipients under 18 years old, recipients who had undergone deceased donor liver transplantation, recipients who had undergone re-transplantation, recipients with impaired renal function such as CKD or HRS, or those with insufficient data
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 |
|---|---|---|
| Observational study, records of blood glucose level after reperfusionAnalyzes blood glucose level after reperfusion by dividing it into two groups: those with blood glucose levels between 110 and 180 and those with blood glucose levels below 110 or above 180. | Other | Group 110 < REP BG < 180 |
Primary outcome
incidence of acute kidney injury
Time frame: within 7 days after surgery
determined by change in sCr according to the Kidney Disease: Improving Global Outcomes (KDIGO) definition (increase in sCr of ≥26.5 mmol litre-1 within 48h or ≥1.5 times baseline within 7 days after surgery)
4 secondary outcomes
incidence of severe AKI
Time frame: within 7 days after surgery
incidence of chronic kidney disease (CKD)
Time frame: within 1 year after surgery
incidence of Major adverse cardiac event (MACE)
Time frame: within postoperative 30 days (POD30)
overall mortality
Time frame: the mortality at overall period (calculated from the date of surgery to the last follow-up) from the date of surgery (up to 10 years)
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 20 Mar 2024.
- Individual participant dataSharing planned: No
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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 Acute Kidney Injury and Hyperglycemia, run by Asan Medical Center 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 20 Mar 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?
incidence of acute kidney injury (time frame: within 7 days after 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 20 Mar 2024.