Amino Acid Infusion in Kidney Transplant Recipients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Infusion Therapy, Saline solution infusion.
- Who it may be relevant to
- Registry conditions: Short-term Graft Function, Metabolic Effects, Nutritional Effect, Immunological &Amp; Inflammatory Markers. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovakia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Amino Acid Infusion on Early Graft Function After Kidney Transplantation
Overview
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.
Detailed description
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.
Interventions
- Drug Infusion Therapy
Infusion of amino acids once daily - dose 1g/kg, maximum 100 g daily for 3 consecutive days starting D1 after kidney transplantation procedure - Drug Saline solution infusion
Infusion of saline solution a s standard rehydration therapy after kidney transplantation
Primary outcome measures
- Improving graft function 3 months after kidney transplantation [Time frame: 90 days after enrollment/kidney transplantation]
Secondary outcome measures (8)
- Decrease of the biopsy proven acute rejection incidence [Time frame: 90 days after enrollment]
- Improving levels of total proteins and albumin [Time frame: 90 days after enrollment/kidney transplantation]
- Lipid profile improvement [Time frame: 90 days after enrollment/kidney transplantation]
- Decreasing the incidence of delayed graft function [Time frame: 7 days after enrollment / kidney transplantation]
- Monitoring the incidence of severe hyperkalemia [Time frame: 90 days after enrollment/kidney transplantation]
- Monitoring the incidence of metabolic acidosis [Time frame: 90 days after enrollment/kidney transplantation]
- Monitoring the incidence of elevated liver enzymes [Time frame: 90 days after enrollment/kidney transplantation]
- Monitoring the incidence of elevated bilirubin [Time frame: 90 days after enrollment/kidney transplantation]
Eligibility criteria
Inclusion criteria
- Adult patients (≥18 years) undergoing deceased or living donor kidney transplantation
- First-time kidney transplant recipients
- No known allergy or contraindication to amino acids
- Stable hemodynamic status post-transplant
- Signed informed consent
Exclusion criteria
- Patients requiring immediate dialysis post-transplant
- Multi-organ transplant recipients
- Severe hepatic dysfunction (Child-Pugh C)
- Uncontrolled infection or sepsis
- Malignancy within the past 5 years (except non-melanoma skin cancer)
- Prior participation in conflicting clinical trials
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Slovakia · 1 center
- University Hospital Martin — Martin
Identifiers
NCT: NCT06929637 · TNO_UNM_3