Impact of Glycemic Control After Reperfusion on Acute Kidney Injury in Living Donor Liver Transplantation

Acute Kidney Injury Clinical Trial

Official title:

Impact of Glycemic Control After Reperfusion on Acute Kidney Injury in Living Donor Liver Transplantation: A Propensity Score-matched Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06320730
• Other study ID #: 2020-0675
• Status: Completed
• Start date: August 25, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2024
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Furthermore, severe AKI, chronic kidney disease (CKD), major adverse cardiac event (MACE) and mortality were also investigated.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3790
• Est. completion date: March 1, 2021
• Est. primary completion date: August 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• End Stage Liver Disease
• Hyperglycemia
• Hypoglycemia
• Liver Diseases
• Wounds and Injuries

Intervention

Other:
• Observational study, records of blood glucose level after reperfusion
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.

Locations

Country	Name	City	State
Korea, Republic of	Jun-Gol Song	Seoul	Song-pa Gu

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	within 7 days after surgery
Secondary	incidence of severe AKI	Severe AKI was defined as KIDIGO stage 2 or 3	within 7 days after surgery
Secondary	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	within 1 year after surgery
Secondary	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	within postoperative 30 days (POD30)
Secondary	overall mortality	overall mortality	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)