Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2025-09-30
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Amino acid
Participants receive amino acids for up to 3 days starting at the time of their cardiac surgery
Amino Acids
The participants receive a continuous infusion of a balanced mixture of amino acids (Trophamine) in a dose of 2g/kg/day (max 100g/day) starting at the time of cardiac surgery up to 3 days
Placebo
Participants receive equivalent volume of placebo for up to 3 days starting at the time of their cardiac surgery
Placebo
The participants receive a continuous infusion of a lactated ringers (placebo), equivalent volume to amino acids, starting at the time of cardiac surgery up to 3 days
Interventions
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Amino Acids
The participants receive a continuous infusion of a balanced mixture of amino acids (Trophamine) in a dose of 2g/kg/day (max 100g/day) starting at the time of cardiac surgery up to 3 days
Placebo
The participants receive a continuous infusion of a lactated ringers (placebo), equivalent volume to amino acids, starting at the time of cardiac surgery up to 3 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* CKD history (GFR\<60ml/min/1.73m2 \[≤1year\] and GFR\<90ml/min/1.73m2 \[\>1 year\])
* serum creatinine defined preoperative AKI.
1 Day
18 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Shina Menon
Associate Professor, Pediatrics
Principal Investigators
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Shina Menon, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Lucile Packard Children's Hospital
Palo Alto, California, United States
Countries
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Other Identifiers
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80133
Identifier Type: -
Identifier Source: org_study_id
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