The study addresses the impact of amino acid infusion in the early post-transplant period on graft function and the incidence of post-transplant complications.
Background and Rationale: Delayed graft function (DGF) remains a significant challenge in kidney transplantation, particularly in recipients of deceased donor organs. DGF, often defined as the need for dialysis within the first post-transplant week, is associated with poorer long-term graft survival and increased immunological risk. Ischemia-reperfusion injury (IRI) plays a crucial role in the pathogenesis of DGF, contributing to oxidative stress, inflammation, and endothelial dysfunction. Strategies to mitigate IRI and enhance early graft recovery are highly sought after. Amino acids play a critical role in cellular metabolism, protein synthesis, and immunomodulation. Prior research suggests that amino acid supplementation may improve nitrogen balance, enhance mitochondrial function, and reduce oxidative stress, potentially benefiting graft recovery. However, there is limited clinical evidence assessing whether perioperative amino acid administration improves graft function in kidney transplant recipients. The AID-KT study aims to evaluate the impact of intravenous amino acid infusion on early graft function following kidney transplantation. Study Design: AID-KT is a prospective, interventional cohort study with a retrospective control group. The intervention group will receive intravenous amino acid (AA) supplementation at a dose of 1g/kg body weight daily for three days post-transplant. The historical control group consists of kidney transplant recipients from previous years who did not receive amino acid infusion. The study will evaluate graft function, metabolic response, and patient outcomes over a 12-month follow-up period.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
100
Infusion of amino acids once daily - dose 1g/kg, maximum 100 g daily for 3 consecutive days starting D1 after kidney transplantation procedure
Infusion of saline solution a s standard rehydration therapy after kidney transplantation
University Hospital Martin
Martin, Slovakia, Slovakia
Improving graft function 3 months after kidney transplantation
Investigators assume infusion of amino acids will improve eGFR in the intervals: 7 days / 14 days / 30 days / 90 days after kidney transplantation.
Time frame: 90 days after enrollment/kidney transplantation
Decrease of the biopsy proven acute rejection incidence
Investigators assume the infusion of amino acids will decrease the incidence of biopsy proven acute rejection in 3rd month after kidney transplantation
Time frame: 90 days after enrollment
Improving levels of total proteins and albumin
Investigators assume infusion amino acids will improve levels of total proteins and albumin.
Time frame: 90 days after enrollment/kidney transplantation
Lipid profile improvement
Investigators assume infusion amino acids will improve levels of total cholesterol, triacyglycerides and LDL-cholesterol.
Time frame: 90 days after enrollment/kidney transplantation
Decreasing the incidence of delayed graft function
Investigators assume the infusion of amino acids will decrease the incidence of DGF defined as a need for hemodialysis first week (7 days) after kidney transplantation.
Time frame: 7 days after enrollment / kidney transplantation
Monitoring the incidence of severe hyperkalemia
Investigators will compare the safety of infusion if amino acids reflected by the incidence of hyperkalemia \> 6.5 mmol/l
Time frame: 90 days after enrollment/kidney transplantation
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Monitoring the incidence of metabolic acidosis
Investigators will compare the safety of infusion if amino acids reflected by the incidence of metabolic acidosis - serum bicarbonate levels \< 20 mmol/l
Time frame: 90 days after enrollment/kidney transplantation
Monitoring the incidence of elevated liver enzymes
Investigators will compare the safety of infusion if amino acids with the incidence of increased levels of liver enzymes (AST, ALT, ALP, GMT) \> 2x Upper Limit of Normal increased levels of total and conjugated bilirubin \> 2x Upper Limit of Normal
Time frame: 90 days after enrollment/kidney transplantation
Monitoring the incidence of elevated bilirubin
Investigators will compare the safety of infusion if amino acids with the incidence of increased levels of total and conjugated bilirubin \> 2x Upper Limit of Normal.
Time frame: 90 days after enrollment/kidney transplantation