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

Completed

• Conditions: Acute Kidney Injury; End Stage Liver Disease; Hyperglycemia; Hypoglycemia
• Interventions: Other: Observational study, records of blood glucose level after reperfusion

• Registration Number: NCT06320730
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study Start: 2020-08-25
• Primary Completion: 2020-08-29
• Study Completion: 2021-03-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-19
• Last Update Submitted: 2024-03-19
• Study First Posted: 2024-03-20
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3790

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 110 < REP BG < 180	Observational study, records of blood glucose level after reperfusion	Those with blood glucose levels over 110 and under 180 after reperfusion in liver transplantation recipients.

Primary Outcome Measures

Name	Time	Method
incidence of acute kidney injury	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)

Secondary Outcome Measures

Name	Time	Method
incidence of severe AKI	within 7 days after surgery	Severe AKI was defined as KIDIGO stage 2 or 3
incidence of chronic kidney disease (CKD)	within 1 year after surgery	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
incidence of Major adverse cardiac event (MACE)	within postoperative 30 days (POD30)	MACE was defined including myocardial infarction (MI), atrial fibrillation (AF), pulmonary thromboembolism (PTE), heart failure (HF), cardiac arrest, and/or stroke
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)	overall mortality

Trial Locations

Locations (1)

Jun-Gol Song; 🇰🇷 Seoul, Song-pa Gu, Korea, Republic of