AKI - Acute Kidney Injury, Liver Transplant; Complications
Conditions
Keywords
Liver Transplantation, Acute Kidney Injury, Amino Acids, KDIGO, NGAL, Randomized Controlled Trial
Brief summary
This prospective, open-label, randomized controlled trial aims to evaluate the efficacy of intravenous amino acid infusion in reducing AKI after LDLT. Eligible adult patients undergoing LDLT will be randomized into two groups: one receiving Continuous infusion of a L-amino acids mixture in a dose of 2 g/kg dry body weight/day (to a maximum 100 g/day) after induction of anesthesia and insertion of CVP line till 72 hours after treatment initiation, and the other receiving standard management. The primary outcome is the incidence of AKI as per KDIGO criteria within 7 days of transplant.
Detailed description
This prospective, open-label, randomized controlled trial aims to evaluate the efficacy of intravenous amino acid infusion in reducing AKI after LDLT. Eligible adult patients undergoing LDLT will be randomized into two groups: one receiving Continuous infusion of a L-amino acids mixture in a dose of 2 g/kg dry body weight/day (to a maximum 100 g/day) after induction of anesthesia and insertion of CVP line till 72 hours after treatment initiation, and the other receiving standard management. The primary outcome is the incidence of AKI as per KDIGO criteria within 7 days of transplant.
Interventions
DRUGL-Amino acid mixture
Continuous infusion of a L-amino acids mixture in a dose of 2 g/kg dry body weight/day (to a maximum 100 g/day) after induction of anesthesia and insertion of CVP line till 72 hours after treatment initiation
OTHERStandard of care
Standard peri tranplant care as per out institution including intra operative and post operative care. Its includes starting of immunosuppression after serial blood investigation monitoring.
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. All LDLT Recipient 2. Age: \> 18 years 3. Signed informed consent
Exclusion criteria
1. Negative consent. 2. Pediatric LDLT. 3. ALF patient undergoing LDLT. 4. Patients on intermittent or continuous renal replacement therapy. 5. Patients with eGFR less then 40 ml per min per 1.73 m2. 6. SLKT and prior Kidney transplant. 7. Patient has a hypersensitivity (known allergy) to one or more of the included amino acids. 8. Patient has a known congenital alteration of amino acid metabolism.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare the incidence of early post transplant AKI | Within 7 days post transplant | To compare the incidence of early post transplant AKI (within 1st week) in patients undergoing LDLT between L-amino acids infusion and standard treatment groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To determine eGFR at Day 30 and 90. | 90 days | To determine eGFR at Day 30 and 90. |
| The use and duration of kidney-replacement therapy during the hospital stay The use and duration of kidney-replacement therapy during the hospital stay | 1 month | The use and duration of kidney-replacement therapy during the hospital stay The use and duration of kidney-replacement therapy during the hospital stay |
| To Determine the severity of early post Liver transplant AKI | 7 days | To Determine the severity of early post Liver transplant AKI |
| In Hospital Mortality | 1 month | In Hospital Mortality |
| Major Morbidity (Clavien-Dindo ≥3) and Early Graft Dysfunction. | 1 month | Major Morbidity (Clavien-Dindo ≥3) and Early Graft Dysfunction. |
| The duration of mechanical ventilation, ICU stay and in hospital stay. | 1 month | The duration of mechanical ventilation, ICU stay and in hospital stay. |
Countries
India
Contacts
Primary ContactRavi Roshan
Backup ContactNilesh Patil
Outcome results
None listed