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1. Fenoldopam to prevent renal replacement therapy after cardiac surgery. Design of the FENO-HSR study

Author

Landoni, G, Bove, T, Pasero, D, Comis, M, Orando, S, Pinelli, F, Guarracino, F, Corcione, A, Galdieri, N, Zucchetti, M, Maglioni, E, Biagioli, B, Pala, G, Frontini, M, Caramelli, F, Persi, B, Renzini, M, Paoletti, F, Lorini, F, Morelli, A, Alvaro, G, Bianco, R, Pittarello, D, Manzato, A, Pedersini, G, Mizzi, A, Lojacono, N, Leoncini, P, Iovino, T, Cariello, C, Baldassarri, R, Camata, A, Padua, G, Frascaroli, G, Leonardi S, Bignami, E, Zangrillo, A, Landoni G, Bove T, Pasero D, Comis M, Orando S, Pinelli F, Guarracino F, Corcione A, Galdieri N, Zucchetti M, Maglioni E, Biagioli B, Pala G, Frontini M, Caramelli F, Persi B, Renzini M, Paoletti F, Lorini F, Morelli A, Alvaro G, Bianco R, Pittarello D, Manzato A, Pedersini G, Mizzi A, Lojacono N, Leoncini P, Iovino T, Cariello C, Baldassarri R, Camata AM, Padua G, Frascaroli G, Bignami E, Zangrillo A, Landoni, G, Bove, T, Pasero, D, Comis, M, Orando, S, Pinelli, F, Guarracino, F, Corcione, A, Galdieri, N, Zucchetti, M, Maglioni, E, Biagioli, B, Pala, G, Frontini, M, Caramelli, F, Persi, B, Renzini, M, Paoletti, F, Lorini, F, Morelli, A, Alvaro, G, Bianco, R, Pittarello, D, Manzato, A, Pedersini, G, Mizzi, A, Lojacono, N, Leoncini, P, Iovino, T, Cariello, C, Baldassarri, R, Camata, A, Padua, G, Frascaroli, G, Leonardi S, Bignami, E, Zangrillo, A, Landoni G, Bove T, Pasero D, Comis M, Orando S, Pinelli F, Guarracino F, Corcione A, Galdieri N, Zucchetti M, Maglioni E, Biagioli B, Pala G, Frontini M, Caramelli F, Persi B, Renzini M, Paoletti F, Lorini F, Morelli A, Alvaro G, Bianco R, Pittarello D, Manzato A, Pedersini G, Mizzi A, Lojacono N, Leoncini P, Iovino T, Cariello C, Baldassarri R, Camata AM, Padua G, Frascaroli G, Bignami E, and Zangrillo A

Abstract

Introduction: Acute kidney injury requiring renal replacement therapy is a serious complication following cardiac surgery associated with poor clinical outcomes. Until now no drug showed nephroprotective effects. Fenoldopam is a dopamine-1 receptor agonist which seems to be effective in improving postoperative renal function. The aim of this paper is to describe the design of the FENO-HSR study, planned to assess the effect of a continuous infusion of fenoldopam in reducing the need for renal replacement therapy in patients with acute kidney injury after cardiac surgery. Methods: We're performing a double blind, placebo-controlled multicentre randomized trial in over 20 Italian hospitals. Patients who develop acute renal failure defined as R of RIFLE score following cardiac surgery are randomized to receive a 96-hours continuous infusion of either fenoldopam (0.025-0.3 µg/kg/min) or placebo. Results: The primary endpoint will be the rate of renal replacement therapy. Secondary endpoints will be: mortality, time on mechanical ventilation, length of intensive care unit and hospital stay, peak serum creatinine and the rate of acute renal failure (following the RIFLE score). Conclusions: This trial is planned to assess if fenoldopam could improve relevant outcomes in patients undergoing cardiac surgery who develop acute renal dysfunction. Results of this double-blind randomized trial could provide important insights to improve the management strategy of patients at high risk for postoperative acute kidney injury.

Published
2010

2. Fenoldopam to prevent renal replacement therapy after cardiac surgery. Design of the FENO-HSR study

Author

Landoni G, Bove T, Pasero D, Comis M, Orando S, Pinelli F, Guarracino F, Corcione A, Galdieri N, Zucchetti M, Maglioni E, Biagioli B, Pala G, Frontini M, Caramelli F, Persi B, Renzini M, Paoletti F, Lorini F, Morelli A, Alvaro G, Bianco R, Pittarello D, Manzato A, Pedersini G, Mizzi A, Lojacono N, Leoncini P, Iovino T, Cariello C, Baldassarri R, Camata AM, Padua G, Frascaroli G, Leonardi S, Bignami E, Zangrillo A, Landoni, Giovanni, Bove, T, Pasero, D, Comis, M, Orando, S, Pinelli, F, Guarracino, F, Corcione, A, Galdieri, N, Zucchetti, M, Maglioni, E, Biagioli, B, Pala, G, Frontini, M, Caramelli, F, Persi, B, Renzini, M, Paoletti, F, Lorini, L, Morelli, A, Alvaro, G, Bianco, R, Pittarello, D, Manzato, A, Pedersini, G, Mizzi, A, Lojacono, N, Leoncini, P, Iovino, T, Cariello, C, Baldassarri, R, Camata, Am, Padua, G, Frascaroli, G, Leonardi, S, Bignami, E, Zangrillo, Alberto, Landoni, G, Lorini, F, Camata, A, Leonardi S, and Zangrillo, A

Subjects
cardiac surgical procedure, Research-Article, fenoldopam, anesthesia, cardiac surgical procedures, acute renal failure, renal replacement therapy, cardiac surgery
Abstract

Introduction: Acute kidney injury requiring renal replacement therapy is a serious complication following cardiac surgery associated with poor clinical outcomes. Until now no drug showed nephroprotective effects. Fenoldopam is a dopamine-1 receptor agonist which seems to be effective in improving postoperative renal function. The aim of this paper is to describe the design of the FENO-HSR study, planned to assess the effect of a continuous infusion of fenoldopam in reducing the need for renal replacement therapy in patients with acute kidney injury after cardiac surgery. Methods: We're performing a double blind, placebo-controlled multicentre randomized trial in over 20 Italian hospitals. Patients who develop acute renal failure defined as R of RIFLE score following cardiac surgery are randomized to receive a 96-hours continuous infusion of either fenoldopam (0.025-0.3 µg/kg/min) or placebo. Results: The primary endpoint will be the rate of renal replacement therapy. Secondary endpoints will be: mortality, time on mechanical ventilation, length of intensive care unit and hospital stay, peak serum creatinine and the rate of acute renal failure (following the RIFLE score). Conclusions: This trial is planned to assess if fenoldopam could improve relevant outcomes in patients undergoing cardiac surgery who develop acute renal dysfunction. Results of this double-blind randomized trial could provide important insights to improve the management strategy of patients at high risk for postoperative acute kidney injury.

Published
2010

5. Combined spinal and epidural anesthesia for open abdominal aortic aneurysm surgery in vigil patients with severe chronic obstructive pulmonary disease ineligible for endovascular aneurysm repair. Analysis of results and description of the technique.

Author

Berardi G, Ferrero E, Fadde M, Lojacono N, Ferri M, Viazzo A, Gaggiano A, Bianchi A, Maggio D, Ganzaroli M, Piazza S, Cumbo P, Lamorgese V, Verdecchia C, and Nessi F

Subjects
Aged, Aged, 80 and over, Aortic Aneurysm, Abdominal complications, Aortic Aneurysm, Abdominal diagnostic imaging, Aortography methods, Bupivacaine analogs & derivatives, Feasibility Studies, Female, Fentanyl, Humans, Italy, Levobupivacaine, Male, Severity of Illness Index, Time Factors, Tomography, X-Ray Computed, Treatment Outcome, Adjuvants, Anesthesia, Anesthesia, Epidural adverse effects, Anesthesia, Spinal adverse effects, Anesthetics, Local, Aortic Aneurysm, Abdominal surgery, Pulmonary Disease, Chronic Obstructive complications, Vascular Surgical Procedures adverse effects
Abstract

This study evaluated the feasibility of open infrarenal abdominal aortic aneurysm (AAA) surgery under peridural and spinal anesthesia (vigil patient) alone in high-risk patients with severe chronic obstructive pulmonary disease (COPD) ineligible for endovascular aneurysm repair (EVAR) or open surgery in general anesthesia. Between January 2005 and July 2007, seven patients underwent open AAA surgery with combined spinal and epidural anesthesia ([CSEA] without intubation) alone. Regional abdominal anesthesia was established by spinal anesthesia at L2-3 (levobupivacaine plus fentanyl) associated with peridural anesthesia at T7-8 (levobupivacaine). In this series (6 males and 1 female) the average age was 76.5 years (70-87); the AAA measured 7 cm in diameter on average (range 6-12.2). The survival rate was 100% (7/7 patients) at 6-12 months postoperative; no morbidities occurred during the postoperative phase. Owing to the small size of the series, no statistically significant conclusions can be drawn; even so, repair surgery was found to be effective, without the occurrence of morbidities or mortalities. In high-risk patients (severe COPD), open surgical repair of infrarenal AAA may be done with CSEA alone without intubation when, because of the patient's health, general anesthesia would pose too high a risk or when EVAR is unfeasible. Furthermore, the authors believe that surgical AAA repair under CSEA in vigil patients is a valid treatment option in those subjects with a high operative risk (severe COPD) and untreatable by either open AAA surgery under general anesthesia or EVAR.

Published
2010

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