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NCT Number: NCT07030933

Amino Acid Infusion in Cardiac Surgery

The goal of this study is to see if an infusion of amino acids given to adult male and female patients during cardiac surgery can help prevent acute kidney injury that commonly occurs when patients undergo cardiac surgery needing cardiopulmonary bypass. The main question the study aims to answer is if a short infusion of amino acids given to study participants during their scheduled heart surgery can decrease rates of acute kidney injury - which will be measured by biological markers of kidney injury in the urine.

The study will be conducted in 2 phases. Participants in the first phase will receive the current standard of anesthetic care for patients having heart surgery and markers of acute kidney injury will be measured before and after their surgery. Participants in the second group will receive the anesthetic standard of care plus a short infusion of amino acids during their surgery. They will also have markers of kidney injury measured before and after their surgery. This study is based on prior studies that showed amino acid infusions are protective against kidney injury; however, these past studies did not look at markers of kidney injury in the urine.

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Key information

Conditions

Acute Kidney Injury Cardiac Surgery Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female patients 18 years of age or older undergoing elective cardiac surgery requiring cardiopulmonary bypass.
  • Anticipated stay of at least one night in the ICU following cardiac surgery.
  • Eligible patients must have a baseline serum creatinine measurement obtained during the current hospitalization, or within 365 days of the current hospitalization.
  • Patients agree to participation and completed informed consent process.

Exclusion criteria

  • Preoperative or planned post-operative need for renal replacement therapy.
  • Stage IV or greater chronic kidney disease, defined as estimated glomular filtration rate of less than 30 mL/minute per 1.73 M^2 of body surface area as calculated by the Cockcroft-Gault equation.
  • Emergent cardiac surgical patients and patients undergoing orthotopic heart transplant.
  • Any patient who has a history of renal transplant.
  • Patients who have a documented allergy or hypersensitivity to one or more of the amino acids.
  • Patients with cognitive impairment who cannot provide consent.
  • Patients with congenital alteration of amino acid metabolism.
  • Any patient who declines to participate in the study.

Treatment and study plan

Travesol 10%

Drug

Travesol 10% (Baxter) will be administered to the post-intervention participants at a dose of 2g per kilogram of ideal body weight for up to 3 days or until the participant's discharge from the intensive care unit.

Primary outcomes

  1. Quantification of acute kidney injury biomarker: tissue inhibitor of metalloproteinases 2 (TIMP-2)

    Time frame: In the first hour upon arrival to the ICU, following completion of surgery. On average 6 hours from start of procedure, up to 12 hours.

    Urinary TIMP-2 via NephroCheck, measured in (ng/mL)/1000.

  2. Quantification of acute kidney injury biomarker: insulin-like growth factor-binding protein 7 (IGFBP7)

    Time frame: Baseline prior to cardiopulmonary bypass

    Urinary IGFBP7, measured in (ng/mL)/1000.

  3. Quantification of acute kidney injury biomarker: insulin-like growth factor-binding protein 7 (IGFBP7)

    Time frame: In the first hour upon arrival to the ICU, following the completion of surgery. On average 6 hours from the start of the procedure, up to 12 hours.

    Urinary IGFBP7, measured in (ng/mL)/1000.

Other outcomes

  1. Quantification of acute kidney injury biomarker: tissue inhibitor of metalloproteinases 2 (TIMP-2)

    Time frame: Baseline prior to cardiopulmonary bypass

    Urinary TIMP-2 via NephroCheck, measured in (ng/mL)/1000.

Study contacts

Contact information is provided by the study sponsor or research team.

Adam Adenwala, MD

CONTACT

[email protected]

office #717-531-2525

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 22, 2025
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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