Amino Acids for Cardiac Surgery Associated AKI

The purpose of this study is to assess the feasibility of amino acid infusions in pediatric cardiac surgery patients.

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Trial opening soon.

Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lucile Packard Children's Hospital

Palo Alto, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Undergoing cardiac surgery and expected to be high risk

Exclusion criteria

preoperative extracorporeal organ support
CKD history (GFR<60ml/min/1.73m2 [≤1year] and GFR<90ml/min/1.73m2 [>1 year])
serum creatinine defined preoperative AKI.

Treatment and study plan

Amino Acids

Drug

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

Other names: AA, Trophamine

Placebo

Drug

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 names: Lactated Ringer

Primary outcomes

Number of Participants with Amino acids Related Adverse Events

Time frame: Baseline, Daily during infusion upto 48 hours after completion of infusion (upto 5 days)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Amino Acids for the Infant at Risk for Acute Kidney Injury After Cardiac Surgery: A Pilot Study

Acronym: AKI

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jun 3, 2025
Registry last updated: Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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