Liver Transplant; ComplicationsNCT07132697
The Efficacy of Intravenous Amino Acids in Reducing the Occurrence of AKI After Live Donor Liver Transplant
A study testing L-Amino acid mixture in people with Liver Transplant; Complications and AKI - Acute Kidney Injury, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Transplant; Complications, AKI - Acute Kidney Injury
- What is being tested?
- L-Amino acid mixture
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 25 Aug 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All LDLT Recipient
- Age: > 18 years
- Signed informed consent
Who cannot join
- Negative consent.
- Pediatric LDLT.
- ALF patient undergoing LDLT.
- Patients on intermittent or continuous renal replacement therapy.
- Patients with eGFR less then 40 ml per min per 1.73 m2.
- SLKT and prior Kidney transplant.
- Patient has a hypersensitivity (known allergy) to one or more of the included amino acids.
- Patient has a known congenital alteration of amino acid metabolism.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Ilbs Hospital, D1 Vasant Kunj, New Delhi
New Delhi, National Capital Territory of Delhi, 110070
Ravi Roshan, MBBS, MS, 8010396811, raviroshan10011994@gmail.com
About this study
Official title: The Efficacy of Intravenous Amino Acids in Reducing the Occurrence of AKI After Live Donor Liver Transplant: An Open Label Randomized Trial
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.
Read the 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.
- Being tested
- L-Amino acid mixture, Standard of care
- Keywords
- Liver Transplantation, Acute Kidney Injury, Amino Acids, KDIGO, NGAL, Randomized Controlled Trial
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-Amino acid mixtureDrug
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 of careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: L-Amino acid mixture; Other: Standard of care |
| Standard care | Active comparator | Standard peri liver transplant care as per our institution Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 7 days post transplant
Secondary outcomes (6)
To Determine the severity of early post Liver transplant AKI
To Determine the severity of early post Liver transplant AKI
Measured: 7 days
To determine eGFR at Day 30 and 90.
To determine eGFR at Day 30 and 90.
Measured: 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
Measured: 1 month
The duration of mechanical ventilation, ICU stay and in hospital stay.
The duration of mechanical ventilation, ICU stay and in hospital stay.
Measured: 1 month
In Hospital Mortality
In Hospital Mortality
Measured: 1 month
Major Morbidity (Clavien-Dindo ≥3) and Early Graft Dysfunction.
Major Morbidity (Clavien-Dindo ≥3) and Early Graft Dysfunction.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start25 Aug 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132697
- Sponsor's protocol ID
- IEC/2025/119/MA05
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Intravenous Amino Acids in Reducing the Occurrence of AKI After Live Donor Liver Transplant: An Open Label Randomized Trial
- ClinicalTrials.gov ID
- NCT07132697
- Acronym / sponsor ID
- IEC/2025/119/MA05
- Keywords
- Liver Transplantation, Acute Kidney Injury, Amino Acids, KDIGO, NGAL, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 25 Aug 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amino acid mixture infusion with standard of care | Experimental | Drug: L-Amino acid mixture, Other: Standard of careContinuous 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 | Other: Standard of careStandard peri liver transplant care as per our institution |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All LDLT Recipient
- Age: > 18 years
- Signed informed consent
Key exclusion criteria (8 listed)
- Negative consent.
- Pediatric LDLT.
- ALF patient undergoing LDLT.
- Patients on intermittent or continuous renal replacement therapy.
- Patients with eGFR less then 40 ml per min per 1.73 m2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-Amino acid mixtureContinuous 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 | Drug | Amino acid mixture infusion with standard of care |
| Standard of careStandard peri tranplant care as per out institution including intra operative and post operative care. Its includes starting of immunosuppression after serial blood investigation monitoring. | Other | Amino acid mixture infusion with standard of care, Standard care |
Primary outcome
To compare the incidence of early post transplant AKI
Time frame: 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
6 secondary outcomes
To Determine the severity of early post Liver transplant AKI
Time frame: 7 days
To determine eGFR at Day 30 and 90.
Time frame: 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
Time frame: 1 month
The duration of mechanical ventilation, ICU stay and in hospital stay.
Time frame: 1 month
In Hospital Mortality
Time frame: 1 month
Major Morbidity (Clavien-Dindo ≥3) and Early Graft Dysfunction.
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-Amino acid mixture in people with Liver Transplant; Complications and AKI - Acute Kidney Injury, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ravi Roshan (+91 8010396811, raviroshan10011994@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the incidence of early post transplant AKI (time frame: Within 7 days post transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.