Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amino acid mixture infusion with standard of care | Experimental | 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 |
|
| Standard care | Active Comparator | Standard peri liver transplant care as per our institution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-Amino acid mixture | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the incidence of early post transplant AKI | 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 | Within 7 days post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| To Determine the severity of early post Liver transplant AKI | To Determine the severity of early post Liver transplant AKI | 7 days |
| To determine eGFR at Day 30 and 90. | To determine eGFR at Day 30 and 90. |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ravi Roshan | Contact | +91 8010396811 | raviroshan10011994@gmail.com | |
| Nilesh Patil | Contact | +91 99115 94576 | dr.nils.p@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ilbs Hospital, D1 Vasant Kunj, New Delhi | New Delhi | National Capital Territory of Delhi | 110070 | India |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard of care | Other | 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. |
|
| 90 days |
| The use and duration of kidney-replacement therapy during the hospital stay The use and duration of kidney-replacement therapy during the hospital stay | 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 duration of mechanical ventilation, ICU stay and in hospital stay. | The duration of mechanical ventilation, ICU stay and in hospital stay. | 1 month |
| In Hospital Mortality | In Hospital Mortality | 1 month |
| Major Morbidity (Clavien-Dindo ≥3) and Early Graft Dysfunction. | Major Morbidity (Clavien-Dindo ≥3) and Early Graft Dysfunction. | 1 month |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided