Amino Acids for Cardiac Surgery Associated AKI

NCT07001098 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 80133
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Kidney Injury

Keywords

cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Amino acids Related Adverse Events

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

Study Arms (2)

Amino acid

EXPERIMENTAL

Participants receive amino acids for up to 3 days starting at the time of their cardiac surgery

Drug: Amino Acids

Placebo

PLACEBO COMPARATOR

Participants receive equivalent volume of placebo for up to 3 days starting at the time of their cardiac surgery

Drug: Placebo

Interventions

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

Also known as: AA, Trophamine

Amino acid

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

Also known as: Lactated Ringer

Placebo

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Undergoing cardiac surgery and expected to be high risk

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Amino Acids; amino-acid, glucose, and electrolyte solution; Ringer's Lactate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Shina Menon, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Pediatrics

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 3, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)