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.

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.

The augmented-feedback rehabilitation technique facilitates the arm motor recovery in patients after a recent stroke.

Previous studies have shown that the motor training in a virtual-environment with the augmented feedback promotes motor learning in normal subjects and in long-term post-stroke patients. We evaluated whether this approach could be useful also for treating patients with arm motor deficits due to a recent stroke. Twenty-four patients were included in the study within 3 months from an ischemic stroke in the territory of the middle cerebral artery. Twelve subjects received virtual-environment-training (VET) therapy for the arm, and twelve patients received an equal amount of a conventional rehabilitation therapy focused to the upper limb. Before and after therapy, the autonomy of daily living activities were assessed with the Functional Independence Measure and the degree of motor impairment was measured with the Fugl-Meyer scale for the upper extremity. For both groups the therapy lasted from 5 to 7 weeks, 1 hour daily for five days a week. The VET therapy group showed 20,2% and 12,4% improvements in the Fugl-Meyer and the Functional Independence Measure scale mean scores respectively. In a comparable way, the conventional therapy determined significant, but smaller scores improvements: 11,3% and 9,1%, respectively. These data indicate that the recovery of arm motor function in patients after a recent stroke is promoted by an augmented feedback strategy applied through a virtual-environment.

Virtual environment system for motor tele-rehabilitation.

The present cutting-edge communication technology applied to the rehabilitation may change the real possibility of providing therapeutic treatments to the patients at their home. In order to confirm this assertion a current study on motor telerehabilitation was undertaken. Through a virtual reality based system, and a complementary video conference apparatus, we supplied five post stroke patients with a motor rehabilitation therapy. The rehabilitation technique was based on the augmented feedback. Subjects underwent the telerehabilitation program for six weeks. Before and after the evaluated therapy, arm motor performance and the activities of daily living were evaluated by the means of clinical scales and measuring the affected arm velocity (end-effector). This pilot study suggested that telerehabilitation could promote the learning of arm motor abilities at distance from the health facilities. From an economic point of view, it could be proposed also as an opportune strategy for saving resources.