Amino Acids for Cardiac Surgery Associated AKI

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT07001098
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Acute Kidney Injury

Eligibility Criteria

Sex
ALL
Age
1 Day - 18 Years
Healthy Volunteers
Not accepted

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
  • 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

Study Details

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

Key Dates

Start date
Sep 30, 2025
Status verified
May 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Amino acid
    Participants receive amino acids for up to 3 days starting at the time of their cardiac surgery
  • Placebo Comparator: Placebo
    Participants receive equivalent volume of placebo for up to 3 days starting at the time of their cardiac surgery

Primary Outcome Measure

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) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Lucile Packard Children's HospitalPalo AltoCalifornia94305-

Find similar trials in Palo Alto, CA

By research site
Lucile Packard Children's Hospital· Palo Alto, CA

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