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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06320730
Other study ID # 2020-0675
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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)
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