Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/30790
Title: 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.
Austin Authors: Landoni, Giovanni;Brambillasca, Claudio;Redaelli, Martina Baiardo;Bradić, Nikola;Ti, Lian Kah;Povšić-Čevra, Zdenko;Nepomniashchikh, Valery A;Zoccai, Giuseppe Biondi;D'Ascenzo, Fabrizio;Romagnoli, Enrico;Scandroglio, Anna Mara;Ballotta, Andrea;Rondello, Nicola;Franco, Annalisa;Massaro, Cristiano;Viscido, Cristina;Calabrò, Maria Grazia;Garofalo, Eugenio;Canichella, Flaminia;Monaco, Fabrizio;Severi, Luca;Pisano, Antonio;Barucco, Gaia;Venditto, Maria;Federici, Francesco;Licheri, Margherita;Paternoster, Gianluca;Trompeo, Annachiara;Belletti, Alessandro;Mantovani, Lorenzo Filippo;Perone, Romina;Dalessandro, Giuseppe;Kroeller, Daniel;Haxhiademi, Dorela;Galbiati, Carola;Tripodi, Vincenzo Francesco;Giardina, Giuseppe;Lembo, Rosalba;Nakhnoukh, Cristina;Guarracino, Fabio;Longhini, Federico;Bove, Tiziana;Zangrillo, Alberto;Bellomo, Rinaldo ;Fominskiy, Evgeny
Affiliation: Intensive Care
IRCCS San Raffaele Scientific Institute, Via Olgettina, 60, 20132 Milan, Italy; Vita-Salute San Raffaele University, Via Olgettina, 58, 20132 Milan, Italy..
IRCCS Centro Cardiologico Monzino, Via Carlo Parea, 4, 20138 Milan, Italy..
IRCCS San Raffaele Scientific Institute, Via Olgettina, 60, 20132 Milan, Italy..
University Hospital Dubrava, Avenija Gojka Šuška 6, 10000 Zagreb, Croatia; University North, Ul. 104. brigade 3, 42000 Varaždin, Croatia..
National University Health System, 5 Lower Kent Ridge Rd, 119074, Singapore City, Singapore..
Special Hospital for Cardiovascular Surgery and Cardiology Magdalena, Ul. Ljudevita Gaja 2, 49217 Krapinske Toplice, Croatia; Josip Juraj Strossmayer University of Osijek, Trg Svetog Trojstva 3, 31000 Osijek, Croatia..
E.N. Meshalkin National Medical Research Center, Rechkunovskaya Ulitsa, 15, Novosibirsk, Russia..
Sapienza Università di Roma, Piazzale Aldo Moro, 5, 00185 Rome, Italy; Mediterranea Cardiocentro, Via Orazio, 2, 80122 Naples, Italy..
Azienda Ospedaliero Universitaria Città della Salute e della Scienza, Corso Bramante, 88, 10126 Turin, Italy..
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Via Pineta Sacchetti, 217, 00168 Rome, Italy; Università Cattolica del Sacro Cuore, Campus di Roma, Largo Francesco Vito, 1, 00168 Rome, Italy..
IRCCS San Raffaele Scientific Institute, Via Olgettina, 60, 20132 Milan, Italy..
IRCCS Centro Cardiologico Monzino, Via Carlo Parea, 4, 20138 Milan, Italy..
IRCCS San Raffaele Scientific Institute, Via Olgettina, 60, 20132 Milan, Italy..
ASO Ordine Mauriziano, Via Magellano, 1, 10128 Turin, Italy..
IRCCS San Raffaele Scientific Institute, Via Olgettina, 60, 20132 Milan, Italy..
Magna Graecia University, Viale Europa, 88100 Catanzaro, Italy..
Azienda Ospedaliera San Camillo Forlanini, Circonvallazione Gianicolense, 87, 00152 Rome, Italy..
IRCCS San Raffaele Scientific Institute, Via Olgettina, 60, 20132 Milan, Italy..
Azienda Ospedaliera San Camillo Forlanini, Circonvallazione Gianicolense, 87, 00152 Rome, Italy..
A.O.R.N. "Dei Colli", Monaldi Hospital, Via Leonardo Bianchi, Naples, Italy..
IRCCS San Raffaele Scientific Institute, Via Olgettina, 60, 20132 Milan, Italy..
A.O.R.N. "Dei Colli", Monaldi Hospital, Via Leonardo Bianchi, Naples, Italy..
Azienda Ospedaliero-Universitaria Sant'Andrea di Roma, Via di Grottarossa, 1035/1039, 00189 Rome, Italy..
IRCCS San Raffaele Scientific Institute, Via Olgettina, 60, 20132 Milan, Italy..
Azienda Ospedaliera Regionale San Carlo, Via Potito Petrone, 85100 Potenza, Italy..
Azienda Ospedaliero Universitaria Città della Salute e della Scienza, Corso Bramante, 88, 10126 Turin, Italy..
IRCCS San Raffaele Scientific Institute, Via Olgettina, 60, 20132 Milan, Italy..
GVM - Maria Cecilia Hospital, Via Corriera, 1, 48033 Cotignola (RA), Italy..
Pineta Grande Hospital, Via Domitiana, km 30/00, 81030 Castel Volturno (CE), Italy..
IRCCS San Raffaele Scientific Institute, Via Olgettina, 60, 20132 Milan, Italy..
IRCCS Humanitas Research Hospital, Via Alessandro Manzoni, 56, 20089 Rozzano (MI), Italy..
Ospedale del Cuore, Fondazione Toscana "Gabriele Monasterio", Via Aurelia Sud, 54100 Massa, Italy..
IRCCS San Raffaele Scientific Institute, Via Olgettina, 60, 20132 Milan, Italy..
Grande Ospedale Metropolitano, Via Giuseppe Melacrino, 21, 89124 Reggio Calabria, Italy..
IRCCS San Raffaele Scientific Institute, Via Olgettina, 60, 20132 Milan, Italy..
Azienda Ospedaliero Universitaria Pisana, Via Roma, 67, 56126 Pisa, Italy..
Magna Graecia University, Viale Europa, 88100 Catanzaro, Italy..
Università degli Studi di Udine, Via Palladio 8, 33100 Udine, Italy; Azienda Sanitaria Universitaria Friuli Centrale, Via Pozzuolo, 330, 33100 Udine, Italy..
IRCCS San Raffaele Scientific Institute, Via Olgettina, 60, 20132 Milan, Italy; Vita-Salute San Raffaele University, Via Olgettina, 58, 20132 Milan, Italy..
IRCCS San Raffaele Scientific Institute, Via Olgettina, 60, 20132 Milan, Italy..
Issue Date: 26-Aug-2022
Date: 2022
Publication information: Contemporary Clinical Trials 2022:121,106898
Abstract: Postoperative acute kidney injury (AKI) is frequent in cardiac surgery patients. Its pathophysiology is complex and involves decreased renal perfusion. Preliminary clinical evidence in critically ill patients shows that amino acids infusion increases renal blood flow and may decrease the incidence and severity of AKI. We designed a study to evaluate the effectiveness of perioperative continuous infusion of amino acids in decreasing AKI. This is a phase III, multi-center, randomized, double-blind, placebo-controlled trial. Adults undergoing cardiac surgery with cardiopulmonary bypass (CPB) are included. Patients are randomly assigned to receive either continuous infusion of a balanced mixture of amino acids in a dose of 2 g/kg ideal body weight/day or placebo (balanced crystalloid solution) from the operating room up to start of renal replacement therapy (RRT), or ICU discharge, or 72 h after the first dose. The primary outcome is the incidence of AKI during hospital stay defined by KDIGO (Kidney Disease: Improving Global Outcomes). Secondary outcomes include the need for, and duration of, RRT, mechanical ventilation; ICU and hospital length of stay; all-cause mortality at ICU, hospital discharge, 30, 90, and 180 days after randomization; quality of life at 180 days. Data will be analyzed in 3500 patients on an intention-to-treat basis. The trial is ongoing and currently recruiting. It will be one of the first randomized controlled studies to assess the relationship between amino acids use and kidney injury in cardiac surgery. If our hypothesis is confirmed, this practice could reduce morbidity in the studied population. This trial was registered on ClinicalTrials.gov with the trial identification NCT03709264 in October 2018.
URI: https://ahro.austin.org.au/austinjspui/handle/1/30790
DOI: 10.1016/j.cct.2022.106898
Journal: Contemporary Clinical Trials
PubMed URL: 36038001
Type: Journal Article
Subjects: Acute kidney injury
Amino acids
Anesthesia
Cardiac surgery
Intensive care
Randomized controlled trial
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