Cardiac SurgeryPhase 3PROTectionNCT03709264
Intravenous Amino Acid Therapy for Kidney Protection in Cardiac Surgery.
A Phase 3 study testing Amino Acids in people with Cardiac Surgery, run by Università Vita-Salute San Raffaele at 22 sites in 3 countries.
Trial summary
To date, no pharmacological agents are proven efficacious in treating perioperative AKI. There is a strong biological rationale for the administration of amino acid in the management of patients at risk of AKI with increases in renal blood flow and GFR of 25 to 60% for several hours after the administration of amino… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Amino Acids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,511 participants
- Where
- 22 sitesin 3 countries
- Study dates
- 7 Oct 2019to 17 Jan 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- age > 18 years
- scheduled cardiac surgery
- expected to stay in ICU at least 1 night after surgery
- signed informed consent
Who cannot join
- Patient currently enrolled into another randomized clinical trial
- Patient currently receiving or scheduled for intermittent or continuous renal replacement therapy
- Patients with CKD of equal or more than CKD stage IV (GFR<30 ml/min/1.73 m2)
- Patient with a kidney transplant
- Patient is not expected to survive ICU or hospital discharge
- Patient previously been enrolled and randomized into this study
Show all 11Show fewer
- Patient has severe liver disease (Child-Pugh score >7 points)
- Patient has a hypersensitivity (known allergy) to one or more of the included amino acids
- Patient has a congenital alteration of amino acid metabolism
- Pregnant or currently breastfeeding patients
- Patients with any of the contraindications reported in the summary product characteristics.
Trial locations and contacts
22 sites in 3 countries.
22 sites in 3 countries
Italy19 sites
Pineta Grande Hospital
Castel Volturno, Caserta
Ospedale Mater Domini
Catanzaro, Calabria
Maria Cecilia Hospital
Cotignola, Ravenna
IRCCS San Martino Istitute
Genoa, Liguria
Ospedale del cuore - Fondazione Toscana Gabriele Monasterio
Massa, Tuscany
IRCCS Ospedale San Donato
Miano, Milano
IRCCS Cardiologico Monzino
Milan, Lombardy, 20100
Ospedale San Raffaele
Milan, 20132
Ospedale Monaldi
Naples, Campania
AOU Policlinico Paolo Giaccone
Palermo
Azienda Ospedaliera Universitaria Pisana
Pisa
Ospedale San Carlo
Potenza, Basilicate
Grande Ospedale Metropolitano
Reggio Calabria
Azienda Ospedaliera Sant'Andrea
Rome, Lazio
Ospedale San Camillo
Rome, Lazio
Istituto Clinico Humanitas
Rozzano, Lombardy
Città della Salute
Turin, Piedmont
Ospedale Ordine Mauriziano
Turin, Piedmont
Ospedale Santa Maria della Misericordia
Udine
Croatia2 sites
University Hospital Dubrava
Dubrava
Magdalena Clinic for Cardiovascular Diseases
Zagreb
About this study
Official title: Intravenous Amino Acid Therapy for Kidney Protection in Cardiac Surgery: a Multi-centre Randomized Blinded Placebo Controlled Clinical Trial.
To date, no pharmacological agents are proven efficacious in treating perioperative AKI. There is a strong biological rationale for the administration of amino acid in the management of patients at risk of AKI with increases in renal blood flow and GFR of 25 to 60% for several hours after the administration of amino acids (Woods LL 1993) mediated by a afferent arteriolar dilation.(Meyer TW 1983) Moreover, animal models have demonstrated that an increase in renal blood flow in response to a short-term amino acid infusion can protect the kidney from acute ischemic insults. Finally, these nephro-protective effects are preserved in critical illness. Cardiac surgery appears to be the best setting to test the likely beneficial renal effects of amino acid because of pathophysiological principles and the ability to intervene before the injury has begun. Although the etiology of AKI in cardiac surgery is multifactorial, renal hypoperfusion is believed to play a major role in this development by decreasing renal perfusion through a reduction in renal blood flow and through the activation of the sympathetic nervous system and the renin-angiotensin system with afferent arteriolar vasoconstriction. In this setting, a global increase in renal blood flow by means of Amino Acid therapy appears a logical and promising intervention.
The primary aim of the study is to determine whether providing continuous infusion of a balanced mixture of amino acids, compared to placebo (balanced crystalloid solution), reduces the incidence of acute kidney injury (AKI) in patients scheduled for cardiac surgery defined as KDIGO stage 1 or greater during hospital stay.
- Conditions
- Cardiac Surgery
- Being tested
- Amino Acids, Placebos
- Keywords
- kidney protection, acute kidney injury, cardiac surgery, amino acids, mortality, ICU
- 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.
Amino AcidsDrug
Patients randomized to experimental arm receive a continuous infusion of a balanced mixture of amino acids in a dose of 2 g/kg ideal body weight/day (to a maximum 100 g/day) from the operating room admission up to either death, start of RRT, ICU discharge or 72 hours after treatment initiation, trough a central venous line
PlacebosDrug
Placebo: standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Amino Acids infusion | Experimental | Not described Receives: Drug: Amino Acids |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
AKI incidence
Incidence of Acute Kidney Injury during hospital stay
Measured: Until hospital discharge, an average of 10 days
Secondary outcomes (6)
Mortality
All-cause mortality at ICU discharge, hospital discharge, 30 and 90 and 180 days after randomization
Measured: 180 days
RRT
Need and duration of renal replacement therapy
Measured: 180 days
ICU stay
Duration of Intensive Care Unit stay
Measured: Until ICU discharge, an average of 2 days
Hospital stay
Duration of hospital stay
Measured: Until hospital discharge, an average of 10 days
Mechanical Ventilation
Need and duration of mechanical ventilation
Measured: Until ICU discharge, an average of 2 days
EQ-5D
Quality of life at 180 days after randomization as measured by the EQ-5D
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start7 Oct 2019
- Primary completion17 Jan 2024
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3,511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Landoni, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709264
- Sponsor's protocol ID
- PROTection/47/OSR
- Acronym
- PROTection
- Status last verified
- Aug 2025
- First submitted
- 9 Oct 2018
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Losiggio R, Redaelli MB, Landoni G, Bellomo R. Intravenous Amino-acid Infusion to Prevent Acute Kidney Injury after Cardiac Surgery: A Review of the Evidence. Ann Thorac Surg. 2025 Aug;120(2):256-266. doi: 10.1016/j.athoracsur.2024.11.020. Epub 2024 Dec 4.
PubMed 39643100Baiardo Redaelli M, Landoni G, Monti G, Bellomo R. Amino acids and the kidney; friends or foes? Curr Opin Clin Nutr Metab Care. 2025 Mar 1;28(2):156-159. doi: 10.1097/MCO.0000000000001083. Epub 2024 Oct 21.
PubMed 39485306Pruna A, Losiggio R, Landoni G, Kotani Y, Redaelli MB, Veneziano M, Lee TC, Zangrillo A, Gaudino MFL, Bellomo R; for Protection Study group. Amino Acid Infusion for Perioperative Functional Renal Protection: A Meta-analysis. J Cardiothorac Vasc Anesth. 2024 Dec;38(12):3076-3085. doi: 10.1053/j.jvca.2024.08.033. Epub 2024 Aug 22.
PubMed 39384419Landoni G, Brambillasca C, Baiardo Redaelli M, Bradic N, Ti LK, Povsic-Cevra Z, Nepomniashchikh VA, Zoccai GB, D'Ascenzo F, Romagnoli E, Scandroglio AM, Ballotta A, Rondello N, Franco A, Massaro C, Viscido C, Calabro MG, Garofalo E, Canichella F, Monaco F, Severi L, Pisano A, Barucco G, Venditto M, Federici F, Licheri M, Paternoster G, Trompeo A, Belletti A, Mantovani LF, Perone R, Dalessandro G, Kroeller D, Haxhiademi D, Galbiati C, Tripodi VF, Giardina G, Lembo R, Nakhnoukh C, Guarracino F, Longhini F, Bove T, Zangrillo A, Bellomo R, Fominskiy E. Intravenous amino acid therapy for kidney protection in cardiac surgery a protocol for a multi-centre randomized blinded placebo controlled clinical trial. The PROTECTION trial. Contemp Clin Trials. 2022 Oct;121:106898. doi: 10.1016/j.cct.2022.106898. Epub 2022 Aug 28.
PubMed 36038001Rosario Losiggio, Martina Baiardo Redaelli, Alessandro Pruna, Giovanni Landoni, Rinaldo Bellomo. The renal effects of amino acids infusion. Signa Vitae. 2024. 20(7);1-4.
Bellomo R, Monaco F, Paternoster G. Intravenous Amino Acids and Kidney Protection. Reply. N Engl J Med. 2024 Nov 21;391(20):1965-1966. doi: 10.1056/NEJMc2412012. No abstract available.
PubMed 39566002Kotani Y, Baiardo Redaelli M, Pruna A, Losiggio R, Cocozza S, Ti LK, Bradic N, Comis M, Landoni G, Bellomo R. Intravenous amino acid for kidney protection: current understanding and future perspectives. Clin Kidney J. 2024 Dec 26;18(2):sfae409. doi: 10.1093/ckj/sfae409. eCollection 2025 Feb.
PubMed 39981140Pruna A, Monaco F, Asiller OO, Delrio S, Yavorovskiy A, Bellomo R, Landoni G. How Would We Prevent Our Own Acute Kidney Injury After Cardiac Surgery? J Cardiothorac Vasc Anesth. 2025 May;39(5):1123-1134. doi: 10.1053/j.jvca.2025.01.019. Epub 2025 Jan 13.
PubMed 39922732Bottussi A, D'Andria Ursoleo J, Agosta VT, De Luca M, Monaco F. The role of amino acids and protein administration in preventing cardiac surgery-associated acute kidney injury. Future Cardiol. 2025 Mar;21(3):191-202. doi: 10.1080/14796678.2025.2463271. Epub 2025 Feb 8.
PubMed 39921856Landoni G, Monaco F, Ti LK, Baiardo Redaelli M, Bradic N, Comis M, Kotani Y, Brambillasca C, Garofalo E, Scandroglio AM, Viscido C, Paternoster G, Franco A, Porta S, Ferrod F, Calabro MG, Pisano A, Vendramin I, Barucco G, Federici F, Severi L, Belletti A, Cortegiani A, Bruni A, Galbiati C, Covino A, Baryshnikova E, Giardina G, Venditto M, Kroeller D, Nakhnoukh C, Mantovani L, Silvetti S, Licheri M, Guarracino F, Lobreglio R, Di Prima AL, Fresilli S, Labanca R, Mucchetti M, Lembo R, Losiggio R, Bove T, Ranucci M, Fominskiy E, Longhini F, Zangrillo A, Bellomo R; PROTECTION Study Group. A Randomized Trial of Intravenous Amino Acids for Kidney Protection. N Engl J Med. 2024 Aug 22;391(8):687-698. doi: 10.1056/NEJMoa2403769. Epub 2024 Jun 12.
PubMed 38865168Baiardo Redaelli M, Monaco F, Bradic N, Scandroglio AM, Ti LK, Belletti A, Viscido C, Licheri M, Guarracino F, Pruna A, Pisano A, Pontillo D, Federici F, Losiggio R, Serena G, Tomasi E, Silvetti S, Ranucci M, Brazzi L, Cortegiani A, Landoni G, Mastroroberto P, Paternoster G, Gaudino MFL, Zangrillo A, Bellomo R; for the PROTECTION Study Group Collaborators. Amino Acid Infusion for Kidney Protection in Cardiac Surgery Patients with Chronic Kidney Disease: A Secondary Analysis of the PROTECTION Trial. Anesthesiology. 2025 May 1;142(5):818-828. doi: 10.1097/ALN.0000000000005336. Epub 2024 Dec 19.
PubMed 39705670Belletti A, Pisano A, Scandroglio AM, Garofalo E, Calabro MG, Ferrod F, Monaco F, Brambillasca C, Baiardo Redaelli M, Meroi F, Fominskiy E, Vignale R, Ajello S, Venditto M, Scquizzato T, Porta S, Losiggio R, Suriano P, Pontillo D, Orso D, Tomasi E, Paternoster G, Lomivorotov V, Longhini F, Landoni G, Zangrillo A, Maisano F, Bellomo R, Pieri M; PROTECTION Study Group Collaborators. Intravenous amino acids for renal protection in patients receiving temporary mechanical circulatory support: a secondary subgroup analysis of the PROTECTION study. Eur J Cardiothorac Surg. 2025 Feb 4;67(2):ezaf035. doi: 10.1093/ejcts/ezaf035.
PubMed 39977357Pontillo D, Rong LQ, Pruna A, Pisano A, Monaco F, Bruni A, Baiardo Redaelli M, Ti LK, Belletti A, Bradic N, Massaro C, Barucco G, Viscido C, Losiggio R, Federici F, Marmiere M, Silvetti S, Marchetti C, Carmosino M, Manazza M, Oliva FM, Cortegiani A, Guarracino F, Ranucci M, Paternoster G, Landoni G, Zangrillo A, Gaudino MFL, Bellomo R; PROTECTION Study Group Collaborators. Impact of Cardiopulmonary Bypass Duration on the Renal Effects of Amino Acids Infusion in Cardiac Surgery Patients. J Cardiothorac Vasc Anesth. 2025 Sep;39(9):2296-2306. doi: 10.1053/j.jvca.2025.05.050. Epub 2025 Jun 2.
PubMed 40571473Landoni G, Oriani A, Ti LK, Losiggio R, Bradic N, Pruna A, Burrell A, Pieri M, Hodgson CL, D'Amico F, Ranucci M, Oliva FM, Comis M, Calabro MG, Viscido C, Ajello S, Ferrod F, Fresilli S, Guarracino F, Damiani D, Pisano A, Bonizzoni MA, Silvetti S, Pontillo D, Neri G, Scquizzato T, Bosco V, Marmiere M, Carmosino M, Labanca R, Federici F, Giardina G, Baiardo Redaelli M, Belletti A, Costamagna A, Fominskiy E, Arangino C, Scandroglio AM, Monti G, Cortegiani A, Paternoster G, Bove T, Bellomo R, Zangrillo A, Monaco F; PROTECTION Study Group Collaborators. Association of duration of amino acids infusion and renal protection: a secondary analysis of the PROTECTION trial. Br J Anaesth. 2026 Jul;137(1):110-117. doi: 10.1016/j.bja.2025.12.054. Epub 2026 Feb 24.
PubMed 41741282Consonni M, Fresilli S, Kotani Y, Garofalo E, Bradic N, Scandroglio AM, Ti LK, Comis M, Oriani A, Pisano A, Belletti A, Guarracino F, Losiggio R, Redaelli MB, Pontillo D, Arangino C, Pruna A, Federici F, D'Amico F, Silvetti S, Labanca R, Ferrod F, Pittella G, Corbo F, Ranucci M, Cortegiani A, Paternoster G, Bove T, Longhini F, Monaco F, Zangrillo A, Piemonti L; PROTECTION Study Group Collaborators. Diabetes does not modify the renal-protective effect of intravenous amino acids infusion after cardiac surgery. J Endocrinol Invest. 2026 May;49(5):1163-1172. doi: 10.1007/s40618-025-02804-0. Epub 2026 Jan 9.
PubMed 41511746
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Amino Acid Therapy for Kidney Protection in Cardiac Surgery: a Multi-centre Randomized Blinded Placebo Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03709264
- Acronym / sponsor ID
- PROTection / PROTection/47/OSR
- Conditions
- Cardiac Surgery
- Keywords
- kidney protection, acute kidney injury, cardiac surgery, amino acids, mortality, ICU
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,511 participants (actual)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 17 Oct 2018 (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.
To date, no pharmacological agents are proven efficacious in treating perioperative AKI. There is a strong biological rationale for the administration of amino acid in the management of patients at risk of AKI with increases in renal blood flow and GFR of 25 to 60% for several hours after the administration of amino acids (Woods LL 1993) mediated by a afferent arteriolar dilation.(Meyer TW 1983) Moreover, animal models have demonstrated that an increase in renal blood flow in response to a short-term amino acid infusion can protect the kidney from acute ischemic insults. Finally, these nephro-protective effects are preserved in critical illness. Cardiac surgery appears to be the best setting to test the likely beneficial renal effects of amino acid because of pathophysiological principles and the ability to intervene before the injury has begun. Although the etiology of AKI in cardiac surgery is multifactorial, renal hypoperfusion is believed to play a major role in this development by decreasing renal perfusion through a reduction in renal blood flow and through the activation of the sympathetic nervous system and the renin-angiotensin system with afferent arteriolar vasoconstriction. In this setting, a global increase in renal blood flow by means of Amino Acid therapy appears a logical and promising intervention.
The primary aim of the study is to determine whether providing continuous infusion of a balanced mixture of amino acids, compared to placebo (balanced crystalloid solution), reduces the incidence of acute kidney injury (AKI) in patients scheduled for cardiac surgery defined as KDIGO stage 1 or greater during hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amino Acids infusion | Experimental | Drug: Amino Acids |
| Placebo | Placebo comparator | Drug: Placebos |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age > 18 years
- scheduled cardiac surgery
- expected to stay in ICU at least 1 night after surgery
- signed informed consent
Key exclusion criteria (11 listed)
- Patient currently enrolled into another randomized clinical trial
- Patient currently receiving or scheduled for intermittent or continuous renal replacement therapy
- Patients with CKD of equal or more than CKD stage IV (GFR<30 ml/min/1.73 m2)
- Patient with a kidney transplant
- Patient is not expected to survive ICU or hospital discharge
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 |
|---|---|---|
| Amino AcidsPatients randomized to experimental arm receive a continuous infusion of a balanced mixture of amino acids in a dose of 2 g/kg ideal body weight/day (to a maximum 100 g/day) from the operating room admission up to either death, start of RRT, ICU discharge or 72 hours after treatment initiation, trough a central venous line | Drug | Amino Acids infusion |
| PlacebosPlacebo: standard treatment | Drug | Placebo |
Primary outcome
AKI incidence
Time frame: Until hospital discharge, an average of 10 days
Incidence of Acute Kidney Injury during hospital stay
6 secondary outcomes
Mortality
Time frame: 180 days
RRT
Time frame: 180 days
ICU stay
Time frame: Until ICU discharge, an average of 2 days
Hospital stay
Time frame: Until hospital discharge, an average of 10 days
Mechanical Ventilation
Time frame: Until ICU discharge, an average of 2 days
EQ-5D
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Background: PubMed 39643100Losiggio R, Redaelli MB, Landoni G, Bellomo R. Intravenous Amino-acid Infusion to Prevent Acute Kidney Injury after Cardiac Surgery: A Review of the Evidence. Ann Thorac Surg. 2025 Aug;120(2):256-266. doi: 10.1016/j.athoracsur.2024.11.020. Epub 2024 Dec 4.
- Background: PubMed 39485306Baiardo Redaelli M, Landoni G, Monti G, Bellomo R. Amino acids and the kidney; friends or foes? Curr Opin Clin Nutr Metab Care. 2025 Mar 1;28(2):156-159. doi: 10.1097/MCO.0000000000001083. Epub 2024 Oct 21.
- Background: PubMed 39384419Pruna A, Losiggio R, Landoni G, Kotani Y, Redaelli MB, Veneziano M, Lee TC, Zangrillo A, Gaudino MFL, Bellomo R; for Protection Study group. Amino Acid Infusion for Perioperative Functional Renal Protection: A Meta-analysis. J Cardiothorac Vasc Anesth. 2024 Dec;38(12):3076-3085. doi: 10.1053/j.jvca.2024.08.033. Epub 2024 Aug 22.
- Background: PubMed 36038001Landoni G, Brambillasca C, Baiardo Redaelli M, Bradic N, Ti LK, Povsic-Cevra Z, Nepomniashchikh VA, Zoccai GB, D'Ascenzo F, Romagnoli E, Scandroglio AM, Ballotta A, Rondello N, Franco A, Massaro C, Viscido C, Calabro MG, Garofalo E, Canichella F, Monaco F, Severi L, Pisano A, Barucco G, Venditto M, Federici F, Licheri M, Paternoster G, Trompeo A, Belletti A, Mantovani LF, Perone R, Dalessandro G, Kroeller D, Haxhiademi D, Galbiati C, Tripodi VF, Giardina G, Lembo R, Nakhnoukh C, Guarracino F, Longhini F, Bove T, Zangrillo A, Bellomo R, Fominskiy E. Intravenous amino acid therapy for kidney protection in cardiac surgery a protocol for a multi-centre randomized blinded placebo controlled clinical trial. The PROTECTION trial. Contemp Clin Trials. 2022 Oct;121:106898. doi: 10.1016/j.cct.2022.106898. Epub 2022 Aug 28.
- BackgroundRosario Losiggio, Martina Baiardo Redaelli, Alessandro Pruna, Giovanni Landoni, Rinaldo Bellomo. The renal effects of amino acids infusion. Signa Vitae. 2024. 20(7);1-4.
- Background: PubMed 39566002Bellomo R, Monaco F, Paternoster G. Intravenous Amino Acids and Kidney Protection. Reply. N Engl J Med. 2024 Nov 21;391(20):1965-1966. doi: 10.1056/NEJMc2412012. No abstract available.
- Background: PubMed 39981140Kotani Y, Baiardo Redaelli M, Pruna A, Losiggio R, Cocozza S, Ti LK, Bradic N, Comis M, Landoni G, Bellomo R. Intravenous amino acid for kidney protection: current understanding and future perspectives. Clin Kidney J. 2024 Dec 26;18(2):sfae409. doi: 10.1093/ckj/sfae409. eCollection 2025 Feb.
- Background: PubMed 39922732Pruna A, Monaco F, Asiller OO, Delrio S, Yavorovskiy A, Bellomo R, Landoni G. How Would We Prevent Our Own Acute Kidney Injury After Cardiac Surgery? J Cardiothorac Vasc Anesth. 2025 May;39(5):1123-1134. doi: 10.1053/j.jvca.2025.01.019. Epub 2025 Jan 13.
- Background: PubMed 39921856Bottussi A, D'Andria Ursoleo J, Agosta VT, De Luca M, Monaco F. The role of amino acids and protein administration in preventing cardiac surgery-associated acute kidney injury. Future Cardiol. 2025 Mar;21(3):191-202. doi: 10.1080/14796678.2025.2463271. Epub 2025 Feb 8.
- Results publication: PubMed 38865168Landoni G, Monaco F, Ti LK, Baiardo Redaelli M, Bradic N, Comis M, Kotani Y, Brambillasca C, Garofalo E, Scandroglio AM, Viscido C, Paternoster G, Franco A, Porta S, Ferrod F, Calabro MG, Pisano A, Vendramin I, Barucco G, Federici F, Severi L, Belletti A, Cortegiani A, Bruni A, Galbiati C, Covino A, Baryshnikova E, Giardina G, Venditto M, Kroeller D, Nakhnoukh C, Mantovani L, Silvetti S, Licheri M, Guarracino F, Lobreglio R, Di Prima AL, Fresilli S, Labanca R, Mucchetti M, Lembo R, Losiggio R, Bove T, Ranucci M, Fominskiy E, Longhini F, Zangrillo A, Bellomo R; PROTECTION Study Group. A Randomized Trial of Intravenous Amino Acids for Kidney Protection. N Engl J Med. 2024 Aug 22;391(8):687-698. doi: 10.1056/NEJMoa2403769. Epub 2024 Jun 12.
- Results publication: PubMed 39705670Baiardo Redaelli M, Monaco F, Bradic N, Scandroglio AM, Ti LK, Belletti A, Viscido C, Licheri M, Guarracino F, Pruna A, Pisano A, Pontillo D, Federici F, Losiggio R, Serena G, Tomasi E, Silvetti S, Ranucci M, Brazzi L, Cortegiani A, Landoni G, Mastroroberto P, Paternoster G, Gaudino MFL, Zangrillo A, Bellomo R; for the PROTECTION Study Group Collaborators. Amino Acid Infusion for Kidney Protection in Cardiac Surgery Patients with Chronic Kidney Disease: A Secondary Analysis of the PROTECTION Trial. Anesthesiology. 2025 May 1;142(5):818-828. doi: 10.1097/ALN.0000000000005336. Epub 2024 Dec 19.
- Results publication: PubMed 39977357Belletti A, Pisano A, Scandroglio AM, Garofalo E, Calabro MG, Ferrod F, Monaco F, Brambillasca C, Baiardo Redaelli M, Meroi F, Fominskiy E, Vignale R, Ajello S, Venditto M, Scquizzato T, Porta S, Losiggio R, Suriano P, Pontillo D, Orso D, Tomasi E, Paternoster G, Lomivorotov V, Longhini F, Landoni G, Zangrillo A, Maisano F, Bellomo R, Pieri M; PROTECTION Study Group Collaborators. Intravenous amino acids for renal protection in patients receiving temporary mechanical circulatory support: a secondary subgroup analysis of the PROTECTION study. Eur J Cardiothorac Surg. 2025 Feb 4;67(2):ezaf035. doi: 10.1093/ejcts/ezaf035.
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Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amino Acids in people with Cardiac Surgery, run by Università Vita-Salute San Raffaele at 22 sites in 3 countries.
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 11 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: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Italy, Croatia, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AKI incidence (time frame: Until hospital discharge, an average of 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03709264, which also lists 15 linked publications.
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 7 Aug 2025.