Amino Acid Infusion in Cardiac Surgery

NCT07030933 | Not Yet Recruiting Phase 4

• 1 other identifier: Study01
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Kidney Injury; Cardiac Surgery

Outcome Measures

Primary Outcomes (3)

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

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

  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.

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

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

  Baseline prior to cardiopulmonary bypass

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

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

  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.

Other Outcomes (1)

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

  Baseline prior to cardiopulmonary bypass

Study Arms (2)

Pre-Implementation - Standard of Care

NO INTERVENTION

Participants in this group will receive their anesthetic care that is the current standard of care at our institution for patients undergoing cardiac surgery with cardiopulmonary bypass.

Post-Implementation - Amino Acid Treatment

EXPERIMENTAL

Participants in this group will receive the standard of anesthetic care at our institution plus treatment of amino acid infusion (Travesol 10%, Baxter) at a dose of 2g per kilogram of ideal body weight per day until their discharge from the intensive care unit or up to 72 hours.

Drug: Travesol 10%

Interventions

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.

Post-Implementation - Amino Acid Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Adam Adenwala, MD

  Assistant Professor, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Adenwala, MD

CONTACT

office #717-531-2525; aadenwala@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 22, 2025
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05