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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aminoacid infusion | Active Comparator | Infusion of amino acids,1 g/kg, maximum of 100g AA a day. |
|
| Placebo arm | Placebo Comparator | Infusion of saline solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infusion Therapy | Drug | Infusion of amino acids once daily - dose 1g/kg, maximum 100 g daily for 3 consecutive days starting D1 after kidney transplantation procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days after enrollment/kidney transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 90 days after enrollment |
| Improving levels of total proteins and albumin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matej Vnučák, assoc.prof., MD, PhD. | Contact | +421434203795 | matej.vnucak@unm.sk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Martin | Martin | Slovakia | 03601 | Slovakia |
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| ID | Term |
|---|---|
| D051799 | Delayed Graft Function |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D018718 | Home Infusion Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D006699 | Home Care Services |
| D003153 | Community Health Services |
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| Saline solution infusion | Drug | Infusion of saline solution a s standard rehydration therapy after kidney transplantation |
|
Investigators assume infusion amino acids will improve levels of total proteins and albumin. |
| 90 days after enrollment/kidney transplantation |
| Lipid profile improvement | Investigators assume infusion amino acids will improve levels of total cholesterol, triacyglycerides and LDL-cholesterol. | 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. | 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 | 90 days after enrollment/kidney transplantation |
| 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 | 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 | 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. | 90 days after enrollment/kidney transplantation |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |