Amino Acids for Cardiac Surgery Associated AKI

NCT ID: NCT07001098

Last Updated: 2025-06-03

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2026-11-30

Brief Summary

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

Detailed Description

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Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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

Group Type EXPERIMENTAL

Amino Acids

Intervention Type 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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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AA, Trophamine Lactated Ringer

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Shina Menon

Associate Professor, Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

Other Identifiers

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80133

Identifier Type: -

Identifier Source: org_study_id

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