Continuous deep sedation versus minimal sedation after cardiac arrest and resuscitation (SED-CARE): A protocol for a randomized clinical trial

A Ceric; J Dankiewicz; J Hästbacka; P Young; V H Niemelä; F Bass; M B Skrifvars; N Hammond; M Saxena; H Levin; G Lilja; M Moseby-Knappe; M Tiainen; M Reinikainen; J Holgersson; C B Kamp; M P Wise; P J McGuigan; J White; K Sweet; T R Keeble; G Glover; P Hopkins; C Remmington; J M Cole; N Gorgoraptis; D G Pogson; P Jackson; J Düring; A Lybeck; J Johnsson; J Unden; A Lundin; J Kåhlin; J Grip; E M Lotman; L Romundstad; P Seidel; P Stammet; T Graf; A Mengel; C Leithner; J Nee; P Druwé; K Ameloot; A Nichol; M Haenggi; M P Hilty; M Iten; C Schrag; M Nafi; M Joannidis; C Robba; T Pellis; J Belohlavek; D Rob; Y M Arabi; S Buabbas; C Yew Woon; A Aneman; A Stewart; M Reade; C Delcourt; A Delaney; M Ramanan; B Venkatesh; L Navarra; B Crichton; A Williams; D Knight; J Tirkkonen; T Oksanen; T Kaakinen; S Bendel; H Friberg; T Cronberg; J C Jakobsen; N Nielsen

doi:10.1111/aas.70022

Continuous deep sedation versus minimal sedation after cardiac arrest and resuscitation (SED-CARE): A protocol for a randomized clinical trial

A Ceric, J Dankiewicz, J Hästbacka, P Young, V H Niemelä, F Bass, M B Skrifvars, N Hammond, M Saxena, H Levin, G Lilja, M Moseby-Knappe, M Tiainen, M Reinikainen, J Holgersson, C B Kamp, M P Wise, P J McGuigan, J White, K SweetT R Keeble, G Glover, P Hopkins, C Remmington, J M Cole, N Gorgoraptis, D G Pogson, P Jackson, J Düring, A Lybeck, J Johnsson, J Unden, A Lundin, J Kåhlin, J Grip, E M Lotman, L Romundstad, P Seidel, P Stammet, T Graf, A Mengel, C Leithner, J Nee, P Druwé, K Ameloot, A Nichol, M Haenggi, M P Hilty, M Iten, C Schrag, M Nafi, M Joannidis, C Robba, T Pellis, J Belohlavek, D Rob, Y M Arabi, S Buabbas, C Yew Woon, A Aneman, A Stewart, M Reade, C Delcourt, A Delaney, M Ramanan, B Venkatesh, L Navarra, B Crichton, A Williams, D Knight, J Tirkkonen, T Oksanen, T Kaakinen, S Bendel, H Friberg, T Cronberg, J C Jakobsen, N Nielsen

Clinic of Internal Medicine II - Cardiology

Abstract

BACKGROUND: Sedation is often provided to resuscitated out-of-hospital cardiac arrest (OHCA) patients to tolerate post-cardiac arrest care, including temperature management. However, the evidence of benefit or harm from routinely administered deep sedation after cardiac arrest is limited. The aim of this trial is to investigate the effects of continuous deep sedation compared to minimal sedation on patient-important outcomes in resuscitated OHCA patients in a large clinical trial.

METHODS: The SED-CARE trial is part of the 2 × 2 × 2 factorial Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation (STEPCARE) trial, a randomized international, multicentre, parallel-group, investigator-initiated, superiority trial with three simultaneous intervention arms. In the SED-CARE trial, adults with sustained return of spontaneous circulation (ROSC) who are comatose following resuscitation from OHCA will be randomized within 4 hours to continuous deep sedation (Richmond agitation and sedation scale (RASS) -4/-5) (intervention) or minimal sedation (RASS 0 to -2) (comparator), for 36 h after ROSC. The primary outcome will be all-cause mortality at 6 months after randomization. The two other components of the STEPCARE trial evaluate sedation and temperature control strategies. Apart from the STEPCARE trial interventions, all other aspects of general intensive care will be according to the local practices of the participating site. Neurological prognostication will be performed according to European Resuscitation Council and European Society of Intensive Care Medicine guidelines by a physician blinded to the allocation group. To detect an absolute risk reduction of 5.6% with an alpha of 0.05, 90% power, 3500 participants will be enrolled. The secondary outcomes will be the proportion of participants with poor functional outcomes 6 months after randomization, serious adverse events in the intensive care unit, and patient-reported overall health status 6 months after randomization.

CONCLUSION: The SED-CARE trial will investigate if continuous deep sedation (RASS -4/-5) for 36 h confers a mortality benefit compared to minimal sedation (RASS 0 to -2) after cardiac arrest.

Original language	English
Journal	Acta Anaesthesiologica Scandinavica
Volume	69
Issue number	5
Pages (from-to)	e70022
ISSN	0001-5172
DOIs	https://doi.org/10.1111/aas.70022
Publication status	Published - 05.2025

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Ceric, A., Dankiewicz, J., Hästbacka, J., Young, P., Niemelä, V. H., Bass, F., Skrifvars, M. B., Hammond, N., Saxena, M., Levin, H., Lilja, G., Moseby-Knappe, M., Tiainen, M., Reinikainen, M., Holgersson, J., Kamp, C. B., Wise, M. P., McGuigan, P. J., White, J., ... Nielsen, N. (2025). Continuous deep sedation versus minimal sedation after cardiac arrest and resuscitation (SED-CARE): A protocol for a randomized clinical trial. Acta Anaesthesiologica Scandinavica, 69(5), e70022. https://doi.org/10.1111/aas.70022

@article{49ea3358e2df45fcb1b994e9096a01fd,

title = "Continuous deep sedation versus minimal sedation after cardiac arrest and resuscitation (SED-CARE): A protocol for a randomized clinical trial",

abstract = "BACKGROUND: Sedation is often provided to resuscitated out-of-hospital cardiac arrest (OHCA) patients to tolerate post-cardiac arrest care, including temperature management. However, the evidence of benefit or harm from routinely administered deep sedation after cardiac arrest is limited. The aim of this trial is to investigate the effects of continuous deep sedation compared to minimal sedation on patient-important outcomes in resuscitated OHCA patients in a large clinical trial.METHODS: The SED-CARE trial is part of the 2 × 2 × 2 factorial Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation (STEPCARE) trial, a randomized international, multicentre, parallel-group, investigator-initiated, superiority trial with three simultaneous intervention arms. In the SED-CARE trial, adults with sustained return of spontaneous circulation (ROSC) who are comatose following resuscitation from OHCA will be randomized within 4 hours to continuous deep sedation (Richmond agitation and sedation scale (RASS) -4/-5) (intervention) or minimal sedation (RASS 0 to -2) (comparator), for 36 h after ROSC. The primary outcome will be all-cause mortality at 6 months after randomization. The two other components of the STEPCARE trial evaluate sedation and temperature control strategies. Apart from the STEPCARE trial interventions, all other aspects of general intensive care will be according to the local practices of the participating site. Neurological prognostication will be performed according to European Resuscitation Council and European Society of Intensive Care Medicine guidelines by a physician blinded to the allocation group. To detect an absolute risk reduction of 5.6% with an alpha of 0.05, 90% power, 3500 participants will be enrolled. The secondary outcomes will be the proportion of participants with poor functional outcomes 6 months after randomization, serious adverse events in the intensive care unit, and patient-reported overall health status 6 months after randomization.CONCLUSION: The SED-CARE trial will investigate if continuous deep sedation (RASS -4/-5) for 36 h confers a mortality benefit compared to minimal sedation (RASS 0 to -2) after cardiac arrest.",

author = "A Ceric and J Dankiewicz and J H{\"a}stbacka and P Young and Niemel{\"a}, {V H} and F Bass and Skrifvars, {M B} and N Hammond and M Saxena and H Levin and G Lilja and M Moseby-Knappe and M Tiainen and M Reinikainen and J Holgersson and Kamp, {C B} and Wise, {M P} and McGuigan, {P J} and J White and K Sweet and Keeble, {T R} and G Glover and P Hopkins and C Remmington and Cole, {J M} and N Gorgoraptis and Pogson, {D G} and P Jackson and J D{\"u}ring and A Lybeck and J Johnsson and J Unden and A Lundin and J K{\aa}hlin and J Grip and Lotman, {E M} and L Romundstad and P Seidel and P Stammet and T Graf and A Mengel and C Leithner and J Nee and P Druw{\'e} and K Ameloot and A Nichol and M Haenggi and Hilty, {M P} and M Iten and C Schrag and M Nafi and M Joannidis and C Robba and T Pellis and J Belohlavek and D Rob and Arabi, {Y M} and S Buabbas and {Yew Woon}, C and A Aneman and A Stewart and M Reade and C Delcourt and A Delaney and M Ramanan and B Venkatesh and L Navarra and B Crichton and A Williams and D Knight and J Tirkkonen and T Oksanen and T Kaakinen and S Bendel and H Friberg and T Cronberg and Jakobsen, {J C} and N Nielsen",

note = "{\textcopyright} 2025 The Author(s). Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.",

year = "2025",

month = may,

doi = "10.1111/aas.70022",

language = "English",

volume = "69",

pages = "e70022",

journal = "Acta Anaesthesiologica Scandinavica",

issn = "0001-5172",

number = "5",

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Ceric, A, Dankiewicz, J, Hästbacka, J, Young, P, Niemelä, VH, Bass, F, Skrifvars, MB, Hammond, N, Saxena, M, Levin, H, Lilja, G, Moseby-Knappe, M, Tiainen, M, Reinikainen, M, Holgersson, J, Kamp, CB, Wise, MP, McGuigan, PJ, White, J, Sweet, K, Keeble, TR, Glover, G, Hopkins, P, Remmington, C, Cole, JM, Gorgoraptis, N, Pogson, DG, Jackson, P, Düring, J, Lybeck, A, Johnsson, J, Unden, J, Lundin, A, Kåhlin, J, Grip, J, Lotman, EM, Romundstad, L, Seidel, P, Stammet, P, Graf, T, Mengel, A, Leithner, C, Nee, J, Druwé, P, Ameloot, K, Nichol, A, Haenggi, M, Hilty, MP, Iten, M, Schrag, C, Nafi, M, Joannidis, M, Robba, C, Pellis, T, Belohlavek, J, Rob, D, Arabi, YM, Buabbas, S, Yew Woon, C, Aneman, A, Stewart, A, Reade, M, Delcourt, C, Delaney, A, Ramanan, M, Venkatesh, B, Navarra, L, Crichton, B, Williams, A, Knight, D, Tirkkonen, J, Oksanen, T, Kaakinen, T, Bendel, S, Friberg, H, Cronberg, T, Jakobsen, JC & Nielsen, N 2025, 'Continuous deep sedation versus minimal sedation after cardiac arrest and resuscitation (SED-CARE): A protocol for a randomized clinical trial', Acta Anaesthesiologica Scandinavica, vol. 69, no. 5, pp. e70022. https://doi.org/10.1111/aas.70022

TY - JOUR

T1 - Continuous deep sedation versus minimal sedation after cardiac arrest and resuscitation (SED-CARE)

T2 - A protocol for a randomized clinical trial

AU - Ceric, A

AU - Dankiewicz, J

AU - Hästbacka, J

AU - Young, P

AU - Niemelä, V H

AU - Bass, F

AU - Skrifvars, M B

AU - Hammond, N

AU - Saxena, M

AU - Levin, H

AU - Lilja, G

AU - Moseby-Knappe, M

AU - Tiainen, M

AU - Reinikainen, M

AU - Holgersson, J

AU - Kamp, C B

AU - Wise, M P

AU - McGuigan, P J

AU - White, J

AU - Sweet, K

AU - Keeble, T R

AU - Glover, G

AU - Hopkins, P

AU - Remmington, C

AU - Cole, J M

AU - Gorgoraptis, N

AU - Pogson, D G

AU - Jackson, P

AU - Düring, J

AU - Lybeck, A

AU - Johnsson, J

AU - Unden, J

AU - Lundin, A

AU - Kåhlin, J

AU - Grip, J

AU - Lotman, E M

AU - Romundstad, L

AU - Seidel, P

AU - Stammet, P

AU - Graf, T

AU - Mengel, A

AU - Leithner, C

AU - Nee, J

AU - Druwé, P

AU - Ameloot, K

AU - Nichol, A

AU - Haenggi, M

AU - Hilty, M P

AU - Iten, M

AU - Schrag, C

AU - Nafi, M

AU - Joannidis, M

AU - Robba, C

AU - Pellis, T

AU - Belohlavek, J

AU - Rob, D

AU - Arabi, Y M

AU - Buabbas, S

AU - Yew Woon, C

AU - Aneman, A

AU - Stewart, A

AU - Reade, M

AU - Delcourt, C

AU - Delaney, A

AU - Ramanan, M

AU - Venkatesh, B

AU - Navarra, L

AU - Crichton, B

AU - Williams, A

AU - Knight, D

AU - Tirkkonen, J

AU - Oksanen, T

AU - Kaakinen, T

AU - Bendel, S

AU - Friberg, H

AU - Cronberg, T

AU - Jakobsen, J C

AU - Nielsen, N

PY - 2025/5

Y1 - 2025/5

N2 - BACKGROUND: Sedation is often provided to resuscitated out-of-hospital cardiac arrest (OHCA) patients to tolerate post-cardiac arrest care, including temperature management. However, the evidence of benefit or harm from routinely administered deep sedation after cardiac arrest is limited. The aim of this trial is to investigate the effects of continuous deep sedation compared to minimal sedation on patient-important outcomes in resuscitated OHCA patients in a large clinical trial.METHODS: The SED-CARE trial is part of the 2 × 2 × 2 factorial Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation (STEPCARE) trial, a randomized international, multicentre, parallel-group, investigator-initiated, superiority trial with three simultaneous intervention arms. In the SED-CARE trial, adults with sustained return of spontaneous circulation (ROSC) who are comatose following resuscitation from OHCA will be randomized within 4 hours to continuous deep sedation (Richmond agitation and sedation scale (RASS) -4/-5) (intervention) or minimal sedation (RASS 0 to -2) (comparator), for 36 h after ROSC. The primary outcome will be all-cause mortality at 6 months after randomization. The two other components of the STEPCARE trial evaluate sedation and temperature control strategies. Apart from the STEPCARE trial interventions, all other aspects of general intensive care will be according to the local practices of the participating site. Neurological prognostication will be performed according to European Resuscitation Council and European Society of Intensive Care Medicine guidelines by a physician blinded to the allocation group. To detect an absolute risk reduction of 5.6% with an alpha of 0.05, 90% power, 3500 participants will be enrolled. The secondary outcomes will be the proportion of participants with poor functional outcomes 6 months after randomization, serious adverse events in the intensive care unit, and patient-reported overall health status 6 months after randomization.CONCLUSION: The SED-CARE trial will investigate if continuous deep sedation (RASS -4/-5) for 36 h confers a mortality benefit compared to minimal sedation (RASS 0 to -2) after cardiac arrest.

AB - BACKGROUND: Sedation is often provided to resuscitated out-of-hospital cardiac arrest (OHCA) patients to tolerate post-cardiac arrest care, including temperature management. However, the evidence of benefit or harm from routinely administered deep sedation after cardiac arrest is limited. The aim of this trial is to investigate the effects of continuous deep sedation compared to minimal sedation on patient-important outcomes in resuscitated OHCA patients in a large clinical trial.METHODS: The SED-CARE trial is part of the 2 × 2 × 2 factorial Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation (STEPCARE) trial, a randomized international, multicentre, parallel-group, investigator-initiated, superiority trial with three simultaneous intervention arms. In the SED-CARE trial, adults with sustained return of spontaneous circulation (ROSC) who are comatose following resuscitation from OHCA will be randomized within 4 hours to continuous deep sedation (Richmond agitation and sedation scale (RASS) -4/-5) (intervention) or minimal sedation (RASS 0 to -2) (comparator), for 36 h after ROSC. The primary outcome will be all-cause mortality at 6 months after randomization. The two other components of the STEPCARE trial evaluate sedation and temperature control strategies. Apart from the STEPCARE trial interventions, all other aspects of general intensive care will be according to the local practices of the participating site. Neurological prognostication will be performed according to European Resuscitation Council and European Society of Intensive Care Medicine guidelines by a physician blinded to the allocation group. To detect an absolute risk reduction of 5.6% with an alpha of 0.05, 90% power, 3500 participants will be enrolled. The secondary outcomes will be the proportion of participants with poor functional outcomes 6 months after randomization, serious adverse events in the intensive care unit, and patient-reported overall health status 6 months after randomization.CONCLUSION: The SED-CARE trial will investigate if continuous deep sedation (RASS -4/-5) for 36 h confers a mortality benefit compared to minimal sedation (RASS 0 to -2) after cardiac arrest.

U2 - 10.1111/aas.70022

DO - 10.1111/aas.70022

M3 - Journal articles

C2 - 40178107

SN - 0001-5172

VL - 69

SP - e70022

JO - Acta Anaesthesiologica Scandinavica

JF - Acta Anaesthesiologica Scandinavica

IS - 5

ER -

Continuous deep sedation versus minimal sedation after cardiac arrest and resuscitation (SED-CARE): A protocol for a randomized clinical trial

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