Amino Acid Infusion in Cardiac Surgery

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT07030933
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Acute Kidney Injury
  • Cardiac Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jun 22, 2025
Start date
Oct 1, 2026
Status verified
May 2026
Primary completion
Oct 1, 2027
Completion
Nov 1, 2027

Study Design

Enrollment
130 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Pre-Implementation - Standard of Care
    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.
  • Experimental: Post-Implementation - Amino Acid Treatment
    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.

Primary Outcome Measure

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. ]

Central Contacts

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