Clinical trial NCT06320730: Impact of Glycemic Control After Reperfusion on Acute Kidney Injury in Living Donor Liver Transplantation
Official title: Impact of Glycemic Control After Reperfusion on Acute Kidney Injury in Living Donor Liver Transplantation: A Propensity Score-matched Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Hyperglycemia
Hypoglycemia
End Stage Liver Disease
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 3790
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: living donor liver transplant recipients at Asan Medical Center, Seoul, Korea, Republic of Korea, from January 2008 to December 2019.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Living donor liver transplantation recipients

Exclusion Criteria:

* 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

Primary outcomes:
measure: incidence of acute kidney injury
timeFrame: within 7 days after surgery
Secondary outcomes:
measure: incidence of severe AKI
timeFrame: within 7 days after surgery
measure: incidence of chronic kidney disease (CKD)
timeFrame: within 1 year after surgery
measure: incidence of Major adverse cardiac event (MACE)
timeFrame: within postoperative 30 days (POD30)
measure: overall mortality
timeFrame: 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)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jun-Gol Song
state: Song-pa Gu
Study officials:
References: