Acute Kidney InjuryPhase 4NCT07030933
Amino Acid Infusion in Cardiac Surgery
A Phase 4 study testing Travesol 10% in people with Acute Kidney Injury and Cardiac Surgery, run by Milton S. Hershey Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Cardiac Surgery
- What is being tested?
- Travesol 10%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Nov 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Travesol 10%
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Travesol 10% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of acute kidney injury biomarker: tissue inhibitor of metalloproteinases 2 (TIMP-2)
Urinary TIMP-2 via NephroCheck, measured in (ng/mL)/1000.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Adenwala, Milton S. Hershey Medical Center
- Investigators
- Adam Adenwala, MD, Principal investigator, Assistant Professor, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030933
- Sponsor's protocol ID
- Study01
- Status last verified
- May 2026
- First submitted
- 3 Jun 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amino Acid Infusion in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07030933
- Acronym / sponsor ID
- Study01
- Conditions
- Acute Kidney Injury, Cardiac Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Travesol 10%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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Travesol 10%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. | Drug | Post-Implementation - Amino Acid Treatment |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Kidney Injury
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
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Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
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Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
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WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam Adenwala, MD principal investigator
Assistant Professor, Department of Anesthesiology
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Travesol 10% in people with Acute Kidney Injury and Cardiac Surgery, run by Milton S. Hershey Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam Adenwala, MD (office #717-531-2525, aadenwala@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.