Amino Acids for Cardiac Surgery Associated AKI

NCT07001098 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-06-03

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

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

DRUG

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

Sponsors & Collaborators

Principal Investigators

  • Shina Menon, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07001098 on ClinicalTrials.gov