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

Giovanni Landoni, Claudio Brambillasca, Martina Baiardo Redaelli, Nikola Bradić, Lian Kah Ti, Zdenko Povšić-Čevra, Valery A. Nepomniashchikh, Giuseppe Biondi Zoccai, Fabrizio D'Ascenzo, Enrico Romagnoli, Anna Mara Scandroglio, Andrea Ballotta, Nicola Rondello, Annalisa Franco, Cristiano Massaro, Cristina Viscido, Maria Grazia Calabrò, Eugenio Garofalo, Flaminia Canichella, Fabrizio MonacoLuca Severi, Antonio Pisano, Gaia Barucco, Maria Venditto, Francesco Federici, Margherita Licheri, Gianluca Paternoster, Annachiara Trompeo, Alessandro Belletti, Lorenzo Filippo Mantovani, Romina Perone, Giuseppe Dalessandro, Daniel Kroeller, Dorela Haxhiademi, Carola Galbiati, Vincenzo Francesco Tripodi, Giuseppe Giardina, Rosalba Lembo, Cristina Nakhnoukh, Fabio Guarracino, Federico Longhini, Tiziana Bove, Alberto Zangrillo, Rinaldo Bellomo, Evgeny Fominskiy

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Abstract

Background: 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. Methods: 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. Discussion: 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. Study registration: This trial was registered on ClinicalTrials.gov with the trial identification NCT03709264 in October 2018.

Original languageEnglish
Article number106898
Number of pages9
JournalContemporary Clinical Trials
Volume121
DOIs
Publication statusPublished - Oct 2022

Keywords

  • Acute kidney injury
  • Amino acids
  • Anesthesia
  • Cardiac surgery
  • Intensive care
  • Randomized controlled trial

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