Amino Acids for Cardiac Surgery Associated AKI

Stanford University

Status and phase: Not yet enrolling; Phase 2

Conditions: Acute Kidney Injury

Treatments: Drug: Amino Acids; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07001098

80133

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 1 day to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Amino acid

Experimental group

Description:

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

Treatment:

Drug: Amino Acids

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo