Enteral versus intravenous approach for the sedation of critically ill patients: A randomized and controlled trial 11 Medical and Health Sciences 1103 Clinical Sciences

Giovanni Mistraletti; Michele Umbrello; Silvia Salini; Sara Salini; Paolo Cadringher; Paolo Formenti; Davide Chiumello; Cristina Villa; Riccarda Russo; Silvia Francesconi; Federico Valdambrini; Giacomo Bellani; Alessandra Palo; Francesca Riccardi; Enrica Ferretti; Maurilio Festa; Anna Maria Gado; Martina Taverna; Cristina Pinna; Alessandro Barbiero; Pier Alda Ferrari; Gaetano Iapichino; Alberto Morabito; Martin Langer; Franco Valenza; Roberto Malacrida; Marco Rambaldi; Paolo Spanu; Stefania Anania; Elisa Andrighi; Alessandra Di Carlo; Federica Martinetti; Serena Barello; Andrea Noto; Gianfranco Capello; Bruno Sabatelli; Giovanni Brenna; Morena Astori; Pietro Placido; Luciano Gattinoni; Alessandro Protti; Francesca Pagan; Virna Berto; Paola Roselli; Giulio Ronzoni; Eduardo Beck; Maurizio Gaiotto; Danilo Radrizzani; Luca Ferla; Riccardo Giudici; Laura Merlini; Antonio Pesenti; Alessia La Bruna; Emanuele Rezoagli; Alberto Lucchini; Antonio Braschi; Thekla Niebel; Marina Selvini; Sergio Cortesi; Attilio Quaini; Giorgio Iotti; Enrico Contri; Antonella Sacchi; Sergio Livigni; Giuseppe Naretto; Alessandro Deprado; Virna Venturi Degli Esposti; Pietro Caironi; Giulio Radeschi; Lorenzo Odetto; Daniele Ferrero; Stefano Cognolato; Roberto Penso; Roberta Vacchelli; Silvano Cardellino; Edda Bosco; Anna Bresciani; Ivana Pozzo; Annachiara Alessio; Vanessa Clarindo Rodrigues; Edna Biase; Nicoletta Vivaldi; Antonella Nava; Francesco Ponzetta; Lucilla Bavutti; Paola Martina; Beatriz Palacios; Giancarla Bergonzini

doi:10.1186/s13054-018-2280-x

Enteral versus intravenous approach for the sedation of critically ill patients: A randomized and controlled trial 11 Medical and Health Sciences 1103 Clinical Sciences

Giovanni Mistraletti, Michele Umbrello, Silvia Salini, Sara Salini, Paolo Cadringher, Paolo Formenti, Davide Chiumello, Cristina Villa, Riccarda Russo, Silvia Francesconi, Federico Valdambrini, Giacomo Bellani, Alessandra Palo, Francesca Riccardi, Enrica Ferretti, Maurilio Festa, Anna Maria Gado, Martina Taverna, Cristina Pinna, Alessandro BarbieroPier Alda Ferrari, Gaetano Iapichino, Alberto Morabito, Martin Langer, Franco Valenza, Roberto Malacrida, Marco Rambaldi, Paolo Spanu, Stefania Anania, Elisa Andrighi, Alessandra Di Carlo, Federica Martinetti, Serena Barello, Andrea Noto, Gianfranco Capello, Bruno Sabatelli, Giovanni Brenna, Morena Astori, Pietro Placido, Luciano Gattinoni, Alessandro Protti, Francesca Pagan, Virna Berto, Paola Roselli, Giulio Ronzoni, Eduardo Beck, Maurizio Gaiotto, Danilo Radrizzani, Luca Ferla, Riccardo Giudici, Laura Merlini, Antonio Pesenti, Alessia La Bruna, Emanuele Rezoagli, Alberto Lucchini, Antonio Braschi, Thekla Niebel, Marina Selvini, Sergio Cortesi, Attilio Quaini, Giorgio Iotti, Enrico Contri, Antonella Sacchi, Sergio Livigni, Giuseppe Naretto, Alessandro Deprado, Virna Venturi Degli Esposti, Pietro Caironi, Giulio Radeschi, Lorenzo Odetto, Daniele Ferrero, Stefano Cognolato, Roberto Penso, Roberta Vacchelli, Silvano Cardellino, Edda Bosco, Anna Bresciani, Ivana Pozzo, Annachiara Alessio, Vanessa Clarindo Rodrigues, Edna Biase, Nicoletta Vivaldi, Antonella Nava, Francesco Ponzetta, Lucilla Bavutti, Paola Martina, Beatriz Palacios, Giancarla Bergonzini

Risultato della ricerca: Contributo in rivista › Articolo in rivista › peer review

5 Citazioni (Scopus)

Abstract

Background: ICU patients must be kept conscious, calm, and cooperative even during the critical phases of illness. Enteral administration of sedative drugs might avoid over sedation, and would be as adequate as intravenous administration in patients who are awake, with fewer side effects and lower costs. This study compares two sedation strategies, for early achievement and maintenance of the target light sedation. Methods: This was a multicenter, single-blind, randomized and controlled trial carried out in 12 Italian ICUs, involving patients with expected mechanical ventilation duration > 72 h at ICU admission and predicted mortality > 12% (Simplified Acute Physiology Score II > 32 points) during the first 24 h on ICU. Patients were randomly assigned to receive intravenous (midazolam, propofol) or enteral (hydroxyzine, lorazepam, and melatonin) sedation. The primary outcome was percentage of work shifts with the patient having an observed Richmond Agitation-Sedation Scale (RASS) = target RASS ±1. Secondary outcomes were feasibility, delirium-free and coma-free days, costs of drugs, length of ICU and hospital stay, and ICU, hospital, and one-year mortality. Results: There were 348 patients enrolled. There were no differences in the primary outcome: enteral 89.8% (74.1-100), intravenous 94.4% (78-100), p = 0.20. Enteral-treated patients had more protocol violations: n = 81 (46.6%) vs 7 (4.2%), p < 0.01; more self-extubations: n = 14 (8.1%) vs 4 (2.4%), p = 0.03; a lighter sedative target (RASS = 0): 93% (71-100) vs 83% (61-100), p < 0.01; and lower total drug costs: 2.39 (0.75-9.78) vs 4.15 (1.20-20.19) €/day with mechanical ventilation (p = 0.01). Conclusions: Although enteral sedation of critically ill patients is cheaper and permits a lighter sedation target, it is not superior to intravenous sedation for reaching the RASS target. Trial registration: ClinicalTrials.gov, NCT01360346. Registered on 25 March 2011.

Lingua originale	English
pagine (da-a)	3-N/A
Rivista	Critical Care
Volume	23
DOI	https://doi.org/10.1186/s13054-018-2280-x
Stato di pubblicazione	Pubblicato - 2019

Keywords

Aged
Anesthesia
Antipruritics
Central Nervous System Depressants
Critical Illness
Deep Sedation
Enteral Nutrition
Female
Humans
Hydroxyzine
Hypnotics and Sedatives
Hypnotics and sedatives
Intensive Care Units
Male
Melatonin
Middle Aged
Nursing education research
Patient care planning
Poisson Distribution
Simplified Acute Physiology Score
Single-Blind Method

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10.1186/s13054-018-2280-x

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Mistraletti, G., Umbrello, M., Salini, S., Salini, S., Cadringher, P., Formenti, P., Chiumello, D., Villa, C., Russo, R., Francesconi, S., Valdambrini, F., Bellani, G., Palo, A., Riccardi, F., Ferretti, E., Festa, M., Gado, A. M., Taverna, M., Pinna, C., ... Bergonzini, G. (2019). Enteral versus intravenous approach for the sedation of critically ill patients: A randomized and controlled trial 11 Medical and Health Sciences 1103 Clinical Sciences. Critical Care, 23, 3-N/A. https://doi.org/10.1186/s13054-018-2280-x

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title = "Enteral versus intravenous approach for the sedation of critically ill patients: A randomized and controlled trial 11 Medical and Health Sciences 1103 Clinical Sciences",

abstract = "Background: ICU patients must be kept conscious, calm, and cooperative even during the critical phases of illness. Enteral administration of sedative drugs might avoid over sedation, and would be as adequate as intravenous administration in patients who are awake, with fewer side effects and lower costs. This study compares two sedation strategies, for early achievement and maintenance of the target light sedation. Methods: This was a multicenter, single-blind, randomized and controlled trial carried out in 12 Italian ICUs, involving patients with expected mechanical ventilation duration > 72 h at ICU admission and predicted mortality > 12% (Simplified Acute Physiology Score II > 32 points) during the first 24 h on ICU. Patients were randomly assigned to receive intravenous (midazolam, propofol) or enteral (hydroxyzine, lorazepam, and melatonin) sedation. The primary outcome was percentage of work shifts with the patient having an observed Richmond Agitation-Sedation Scale (RASS) = target RASS ±1. Secondary outcomes were feasibility, delirium-free and coma-free days, costs of drugs, length of ICU and hospital stay, and ICU, hospital, and one-year mortality. Results: There were 348 patients enrolled. There were no differences in the primary outcome: enteral 89.8% (74.1-100), intravenous 94.4% (78-100), p = 0.20. Enteral-treated patients had more protocol violations: n = 81 (46.6%) vs 7 (4.2%), p < 0.01; more self-extubations: n = 14 (8.1%) vs 4 (2.4%), p = 0.03; a lighter sedative target (RASS = 0): 93% (71-100) vs 83% (61-100), p < 0.01; and lower total drug costs: 2.39 (0.75-9.78) vs 4.15 (1.20-20.19) €/day with mechanical ventilation (p = 0.01). Conclusions: Although enteral sedation of critically ill patients is cheaper and permits a lighter sedation target, it is not superior to intravenous sedation for reaching the RASS target. Trial registration: ClinicalTrials.gov, NCT01360346. Registered on 25 March 2011.",

keywords = "Aged, Anesthesia, Antipruritics, Central Nervous System Depressants, Critical Illness, Deep Sedation, Enteral Nutrition, Female, Humans, Hydroxyzine, Hypnotics and Sedatives, Hypnotics and sedatives, Intensive Care Units, Male, Melatonin, Middle Aged, Nursing education research, Patient care planning, Poisson Distribution, Simplified Acute Physiology Score, Single-Blind Method, Aged, Anesthesia, Antipruritics, Central Nervous System Depressants, Critical Illness, Deep Sedation, Enteral Nutrition, Female, Humans, Hydroxyzine, Hypnotics and Sedatives, Hypnotics and sedatives, Intensive Care Units, Male, Melatonin, Middle Aged, Nursing education research, Patient care planning, Poisson Distribution, Simplified Acute Physiology Score, Single-Blind Method",

author = "Giovanni Mistraletti and Michele Umbrello and Silvia Salini and Sara Salini and Paolo Cadringher and Paolo Formenti and Davide Chiumello and Cristina Villa and Riccarda Russo and Silvia Francesconi and Federico Valdambrini and Giacomo Bellani and Alessandra Palo and Francesca Riccardi and Enrica Ferretti and Maurilio Festa and Gado, {Anna Maria} and Martina Taverna and Cristina Pinna and Alessandro Barbiero and Ferrari, {Pier Alda} and Gaetano Iapichino and Alberto Morabito and Martin Langer and Franco Valenza and Roberto Malacrida and Marco Rambaldi and Paolo Spanu and Stefania Anania and Elisa Andrighi and {Di Carlo}, Alessandra and Federica Martinetti and Serena Barello and Andrea Noto and Gianfranco Capello and Bruno Sabatelli and Giovanni Brenna and Morena Astori and Pietro Placido and Luciano Gattinoni and Alessandro Protti and Francesca Pagan and Virna Berto and Paola Roselli and Giulio Ronzoni and Eduardo Beck and Maurizio Gaiotto and Danilo Radrizzani and Luca Ferla and Riccardo Giudici and Laura Merlini and Antonio Pesenti and {La Bruna}, Alessia and Emanuele Rezoagli and Alberto Lucchini and Antonio Braschi and Thekla Niebel and Marina Selvini and Sergio Cortesi and Attilio Quaini and Giorgio Iotti and Enrico Contri and Antonella Sacchi and Sergio Livigni and Giuseppe Naretto and Alessandro Deprado and {Venturi Degli Esposti}, Virna and Pietro Caironi and Giulio Radeschi and Lorenzo Odetto and Daniele Ferrero and Stefano Cognolato and Roberto Penso and Roberta Vacchelli and Silvano Cardellino and Edda Bosco and Anna Bresciani and Ivana Pozzo and Annachiara Alessio and {Clarindo Rodrigues}, Vanessa and Edna Biase and Nicoletta Vivaldi and Antonella Nava and Francesco Ponzetta and Lucilla Bavutti and Paola Martina and Beatriz Palacios and Giancarla Bergonzini",

year = "2019",

doi = "10.1186/s13054-018-2280-x",

language = "English",

volume = "23",

pages = "3--N/A",

journal = "Critical Care",

issn = "1364-8535",

publisher = "BioMed Central Ltd.",

}

Mistraletti, G, Umbrello, M, Salini, S, Salini, S, Cadringher, P, Formenti, P, Chiumello, D, Villa, C, Russo, R, Francesconi, S, Valdambrini, F, Bellani, G, Palo, A, Riccardi, F, Ferretti, E, Festa, M, Gado, AM, Taverna, M, Pinna, C, Barbiero, A, Ferrari, PA, Iapichino, G, Morabito, A, Langer, M, Valenza, F, Malacrida, R, Rambaldi, M, Spanu, P, Anania, S, Andrighi, E, Di Carlo, A, Martinetti, F, Barello, S, Noto, A, Capello, G, Sabatelli, B, Brenna, G, Astori, M, Placido, P, Gattinoni, L, Protti, A, Pagan, F, Berto, V, Roselli, P, Ronzoni, G, Beck, E, Gaiotto, M, Radrizzani, D, Ferla, L, Giudici, R, Merlini, L, Pesenti, A, La Bruna, A, Rezoagli, E, Lucchini, A, Braschi, A, Niebel, T, Selvini, M, Cortesi, S, Quaini, A, Iotti, G, Contri, E, Sacchi, A, Livigni, S, Naretto, G, Deprado, A, Venturi Degli Esposti, V, Caironi, P, Radeschi, G, Odetto, L, Ferrero, D, Cognolato, S, Penso, R, Vacchelli, R, Cardellino, S, Bosco, E, Bresciani, A, Pozzo, I, Alessio, A, Clarindo Rodrigues, V, Biase, E, Vivaldi, N, Nava, A, Ponzetta, F, Bavutti, L, Martina, P, Palacios, B & Bergonzini, G 2019, 'Enteral versus intravenous approach for the sedation of critically ill patients: A randomized and controlled trial 11 Medical and Health Sciences 1103 Clinical Sciences', Critical Care, vol. 23, pagg. 3-N/A. https://doi.org/10.1186/s13054-018-2280-x

TY - JOUR

T1 - Enteral versus intravenous approach for the sedation of critically ill patients: A randomized and controlled trial 11 Medical and Health Sciences 1103 Clinical Sciences

AU - Mistraletti, Giovanni

AU - Umbrello, Michele

AU - Salini, Silvia

AU - Salini, Sara

AU - Cadringher, Paolo

AU - Formenti, Paolo

AU - Chiumello, Davide

AU - Villa, Cristina

AU - Russo, Riccarda

AU - Francesconi, Silvia

AU - Valdambrini, Federico

AU - Bellani, Giacomo

AU - Palo, Alessandra

AU - Riccardi, Francesca

AU - Ferretti, Enrica

AU - Festa, Maurilio

AU - Gado, Anna Maria

AU - Taverna, Martina

AU - Pinna, Cristina

AU - Barbiero, Alessandro

AU - Ferrari, Pier Alda

AU - Iapichino, Gaetano

AU - Morabito, Alberto

AU - Langer, Martin

AU - Valenza, Franco

AU - Malacrida, Roberto

AU - Rambaldi, Marco

AU - Spanu, Paolo

AU - Anania, Stefania

AU - Andrighi, Elisa

AU - Di Carlo, Alessandra

AU - Martinetti, Federica

AU - Barello, Serena

AU - Noto, Andrea

AU - Capello, Gianfranco

AU - Sabatelli, Bruno

AU - Brenna, Giovanni

AU - Astori, Morena

AU - Placido, Pietro

AU - Gattinoni, Luciano

AU - Protti, Alessandro

AU - Pagan, Francesca

AU - Berto, Virna

AU - Roselli, Paola

AU - Ronzoni, Giulio

AU - Beck, Eduardo

AU - Gaiotto, Maurizio

AU - Radrizzani, Danilo

AU - Ferla, Luca

AU - Giudici, Riccardo

AU - Merlini, Laura

AU - Pesenti, Antonio

AU - La Bruna, Alessia

AU - Rezoagli, Emanuele

AU - Lucchini, Alberto

AU - Braschi, Antonio

AU - Niebel, Thekla

AU - Selvini, Marina

AU - Cortesi, Sergio

AU - Quaini, Attilio

AU - Iotti, Giorgio

AU - Contri, Enrico

AU - Sacchi, Antonella

AU - Livigni, Sergio

AU - Naretto, Giuseppe

AU - Deprado, Alessandro

AU - Venturi Degli Esposti, Virna

AU - Caironi, Pietro

AU - Radeschi, Giulio

AU - Odetto, Lorenzo

AU - Ferrero, Daniele

AU - Cognolato, Stefano

AU - Penso, Roberto

AU - Vacchelli, Roberta

AU - Cardellino, Silvano

AU - Bosco, Edda

AU - Bresciani, Anna

AU - Pozzo, Ivana

AU - Alessio, Annachiara

AU - Clarindo Rodrigues, Vanessa

AU - Biase, Edna

AU - Vivaldi, Nicoletta

AU - Nava, Antonella

AU - Ponzetta, Francesco

AU - Bavutti, Lucilla

AU - Martina, Paola

AU - Palacios, Beatriz

AU - Bergonzini, Giancarla

PY - 2019

Y1 - 2019

N2 - Background: ICU patients must be kept conscious, calm, and cooperative even during the critical phases of illness. Enteral administration of sedative drugs might avoid over sedation, and would be as adequate as intravenous administration in patients who are awake, with fewer side effects and lower costs. This study compares two sedation strategies, for early achievement and maintenance of the target light sedation. Methods: This was a multicenter, single-blind, randomized and controlled trial carried out in 12 Italian ICUs, involving patients with expected mechanical ventilation duration > 72 h at ICU admission and predicted mortality > 12% (Simplified Acute Physiology Score II > 32 points) during the first 24 h on ICU. Patients were randomly assigned to receive intravenous (midazolam, propofol) or enteral (hydroxyzine, lorazepam, and melatonin) sedation. The primary outcome was percentage of work shifts with the patient having an observed Richmond Agitation-Sedation Scale (RASS) = target RASS ±1. Secondary outcomes were feasibility, delirium-free and coma-free days, costs of drugs, length of ICU and hospital stay, and ICU, hospital, and one-year mortality. Results: There were 348 patients enrolled. There were no differences in the primary outcome: enteral 89.8% (74.1-100), intravenous 94.4% (78-100), p = 0.20. Enteral-treated patients had more protocol violations: n = 81 (46.6%) vs 7 (4.2%), p < 0.01; more self-extubations: n = 14 (8.1%) vs 4 (2.4%), p = 0.03; a lighter sedative target (RASS = 0): 93% (71-100) vs 83% (61-100), p < 0.01; and lower total drug costs: 2.39 (0.75-9.78) vs 4.15 (1.20-20.19) €/day with mechanical ventilation (p = 0.01). Conclusions: Although enteral sedation of critically ill patients is cheaper and permits a lighter sedation target, it is not superior to intravenous sedation for reaching the RASS target. Trial registration: ClinicalTrials.gov, NCT01360346. Registered on 25 March 2011.

AB - Background: ICU patients must be kept conscious, calm, and cooperative even during the critical phases of illness. Enteral administration of sedative drugs might avoid over sedation, and would be as adequate as intravenous administration in patients who are awake, with fewer side effects and lower costs. This study compares two sedation strategies, for early achievement and maintenance of the target light sedation. Methods: This was a multicenter, single-blind, randomized and controlled trial carried out in 12 Italian ICUs, involving patients with expected mechanical ventilation duration > 72 h at ICU admission and predicted mortality > 12% (Simplified Acute Physiology Score II > 32 points) during the first 24 h on ICU. Patients were randomly assigned to receive intravenous (midazolam, propofol) or enteral (hydroxyzine, lorazepam, and melatonin) sedation. The primary outcome was percentage of work shifts with the patient having an observed Richmond Agitation-Sedation Scale (RASS) = target RASS ±1. Secondary outcomes were feasibility, delirium-free and coma-free days, costs of drugs, length of ICU and hospital stay, and ICU, hospital, and one-year mortality. Results: There were 348 patients enrolled. There were no differences in the primary outcome: enteral 89.8% (74.1-100), intravenous 94.4% (78-100), p = 0.20. Enteral-treated patients had more protocol violations: n = 81 (46.6%) vs 7 (4.2%), p < 0.01; more self-extubations: n = 14 (8.1%) vs 4 (2.4%), p = 0.03; a lighter sedative target (RASS = 0): 93% (71-100) vs 83% (61-100), p < 0.01; and lower total drug costs: 2.39 (0.75-9.78) vs 4.15 (1.20-20.19) €/day with mechanical ventilation (p = 0.01). Conclusions: Although enteral sedation of critically ill patients is cheaper and permits a lighter sedation target, it is not superior to intravenous sedation for reaching the RASS target. Trial registration: ClinicalTrials.gov, NCT01360346. Registered on 25 March 2011.

KW - Aged

KW - Anesthesia

KW - Antipruritics

KW - Central Nervous System Depressants

KW - Critical Illness

KW - Deep Sedation

KW - Enteral Nutrition

KW - Female

KW - Humans

KW - Hydroxyzine

KW - Hypnotics and Sedatives

KW - Hypnotics and sedatives

KW - Intensive Care Units

KW - Male

KW - Melatonin

KW - Middle Aged

KW - Nursing education research

KW - Patient care planning

KW - Poisson Distribution

KW - Simplified Acute Physiology Score

KW - Single-Blind Method

KW - Aged

KW - Anesthesia

KW - Antipruritics

KW - Central Nervous System Depressants

KW - Critical Illness

KW - Deep Sedation

KW - Enteral Nutrition

KW - Female

KW - Humans

KW - Hydroxyzine

KW - Hypnotics and Sedatives

KW - Hypnotics and sedatives

KW - Intensive Care Units

KW - Male

KW - Melatonin

KW - Middle Aged

KW - Nursing education research

KW - Patient care planning

KW - Poisson Distribution

KW - Simplified Acute Physiology Score

KW - Single-Blind Method

UR - http://hdl.handle.net/10807/142603

UR - http://ccforum.com/content/17

U2 - 10.1186/s13054-018-2280-x

DO - 10.1186/s13054-018-2280-x

M3 - Article

SN - 1364-8535

VL - 23

SP - 3-N/A

JO - Critical Care

JF - Critical Care

ER -

Enteral versus intravenous approach for the sedation of critically ill patients: A randomized and controlled trial 11 Medical and Health Sciences 1103 Clinical Sciences

Abstract

Keywords

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