Amino Acids for Cardiac Surgery Associated AKI

Phase 2Not Yet RecruitingNCT07001098

Stanford University30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Acute Kidney Injury

Interventions

Amino AcidsDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 1 DayMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Lucile Packard Children's Hospital

Palo Alto, California, United States

Outcomes

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)

Data from ClinicalTrials.gov

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