Intravenous Amino Acid Therapy for Kidney Protection in Cardiac Surgery.

PHASE3CompletedINTERVENTIONAL
Enrollment

3,511

Participants

Timeline

Start Date

October 7, 2019

Primary Completion Date

January 17, 2024

Study Completion Date

January 17, 2025

Conditions
Cardiac Surgery
Interventions
DRUG

Amino Acids

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

DRUG

Placebos

Placebo: standard treatment

Trial Locations (22)

20100

IRCCS Cardiologico Monzino, Milan

20132

Ospedale San Raffaele, Milan

Unknown

University Hospital Dubrava, Dubrava

Magdalena Clinic for Cardiovascular Diseases, Zagreb

Ospedale San Carlo, Potenza

Ospedale Mater Domini, Catanzaro

Ospedale Monaldi, Napoli

Pineta Grande Hospital, Castel Volturno

Azienda Ospedaliera Sant'Andrea, Rome

Ospedale San Camillo, Rome

IRCCS San Martino Istitute, Genoa

Istituto Clinico Humanitas, Rozzano

IRCCS Ospedale San Donato, Miano

Città della Salute, Turin

Ospedale Ordine Mauriziano, Turin

Maria Cecilia Hospital, Cotignola

Ospedale del cuore - Fondazione Toscana Gabriele Monasterio, Massa

AOU Policlinico Paolo Giaccone, Palermo

Azienda Ospedaliera Universitaria Pisana, Pisa

Grande Ospedale Metropolitano, Reggio Calabria

Ospedale Santa Maria della Misericordia, Udine

National University Hospital, Singapore

All Listed Sponsors
lead

Università Vita-Salute San Raffaele

OTHER

NCT03709264 - Intravenous Amino Acid Therapy for Kidney Protection in Cardiac Surgery. | Biotech Hunter | Biotech Hunter