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

A Ceric¹, J Dankiewicz², J Hästbacka³, P Young^{4

5

6

7}, V H Niemelä⁸, F Bass^{9

10}, M B Skrifvars⁸, N Hammond^{11

12}, M Saxena¹³, H Levin^{14

15}, G Lilja^{16

17}, M Moseby-Knappe^{14

18}, M Tiainen¹⁹, M Reinikainen^{20

21}, J Holgersson^{22

23}, C B Kamp^{24

25}, M P Wise²⁶, P J McGuigan^{27

28}, J White²⁶, K Sweet²⁹, T R Keeble^{30

31}, G Glover³², P Hopkins^{33

34}, C Remmington^{35

36}, J M Cole³⁷, N Gorgoraptis³⁸, D G Pogson³⁹, P Jackson⁴⁰, J Düring⁴¹, A Lybeck⁴², J Johnsson⁴³, J Unden^{44

45}, A Lundin⁴⁶, J Kåhlin^{47

48}, J Grip^{49

50}, E M Lotman⁵¹, L Romundstad^{52

53}, P Seidel⁵⁴, P Stammet^{55

56}, T Graf^{57

58}, A Mengel⁵⁹, C Leithner⁶⁰, J Nee⁶¹, P Druwé⁶², K Ameloot⁶³, A Nichol^{64

65

66}, M Haenggi⁶⁷, M P Hilty⁶⁸, M Iten⁶⁹, C Schrag⁷⁰, M Nafi⁷¹, M Joannidis⁷², C Robba⁷³, T Pellis⁷⁴, J Belohlavek^{75

76}, D Rob⁷⁷, Y M Arabi⁷⁸, S Buabbas⁷⁹, C Yew Woon^{80

81

82}, A Aneman^{83

84

85}, A Stewart⁸⁶, M Reade⁸⁷, C Delcourt^{88

89}, A Delaney⁹⁰, M Ramanan^{91

92

93}, B Venkatesh⁹, L Navarra⁵, B Crichton⁵, A Williams⁹⁴, D Knight⁹⁵, J Tirkkonen⁹⁶, T Oksanen⁹⁷, T Kaakinen^{98

99}, S Bendel^{20

21}, H Friberg^{100

101}, T Cronberg^{16

17}, J C Jakobsen^{102

103}, N Nielsen^{22

23}

Affiliations

¹ Anesthesia and Intensive Care, Department of Clinical Sciences, Lund University, Skane University Hospital, Malmö, Sweden.
² Department of Clinical Sciences Lund, Section of Cardiology, Skåne University Hospital, Malmö, Sweden.
³ Faculty of Medicine and Health Technology, Tampere University Hospital, Wellbeing Services County of Pirkanmaa and Tampere University, Tampere, Finland.
⁴ Intensive Care Unit, Wellington Hospital, Wellington, New Zealand.
⁵ Medical Research Institute of New Zealand, Wellington, New Zealand.
⁶ Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia.
⁷ Department of Critical Care, University of Melbourne, Melbourne, Victoria, Australia.
⁸ Department of Anaesthesia and Intensive Care, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
⁹ The George Institute for Global Health, Sydney, Australia.
¹⁰ Royal North Shore Hospital, Sydney, Australia.
¹¹ Critical Care Program, The George Institute for Global Health, UNSW, Sydney, Australia.
¹² Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital, St Leonards, Australia.
¹³ Critical Care Division and Department of Intensive Care Medicine, The George Institute for Global Health and St George Hospital Clinical School, University of New South Wales, Sydney, Australia.
¹⁴ Department of Clinical Sciences Lund, Lund University, Lund, Sweden.
¹⁵ Department of Research, Development, Education and Innovation, Skåne University Hospital, Lund, Sweden.
¹⁶ Neurology, Department of Clinical Sciences Lund, Lund University, Lund, Sweden.
¹⁷ Department of Neurology, Skåne University Hospital, Lund, Sweden.
¹⁸ Department of Neurology and Rehabilitation, Skåne University Hospital, Lund, Sweden.
¹⁹ Department of Neurology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
²⁰ Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland.
²¹ Department of Anaesthesiology and Intensive Care, Kuopio University Hospital, Kuopio, Finland.
²² Department of Clinical Sciences Lund, Anesthesia and Intensive Care, Lund University, Lund, Sweden.
²³ Department of Anesthesia and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden.
²⁴ Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
²⁵ Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.
²⁶ Adult Critical Care, University Hospital of Wales, Cardiff, UK.
²⁷ Wellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast, Belfast, UK.
²⁸ Regional Intensive care Unit, Royal Victoria Hospital, Belfast, United Kingdom.
²⁹ University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
³⁰ Essex Cardiothoracic Centre, MSE NHSFT, Essex, UK.
³¹ Anglia Ruskin School of Medicine & MTRC, ARU, Chelmsford, Essex, United Kingdom.
³² Department of Critical Care, Guy's and St Thomas NHS Foundation Trust, London, UK.
³³ Faculty of Life, Sciences and Medicine, King's College, Intensive Care Medicine, Centre for Human and Applied Physiological Sciences, School of Basic and Medical Biosciences, London, UK.
³⁴ Intensive Care Medicine, King's Critical Care, King's College Hospital, NHS Foundation Trust, London, UK.
³⁵ Department of Pharmacy and Adult Critical Care, Guy's and St Thomas' NHS Foundation Trust, London, UK.
³⁶ Institute of Pharmaceutical Sciences, School of Cancer & Pharmaceutical Sciences, King's College London, London, UK.
³⁷ Critical Care, University Hospital of Wales, Cardiff, UK.
³⁸ BartsHealth NHS Trust, London, UK.
³⁹ Department of Critical Care, Portsmouth University Hospitals Trust, Portsmouth, UK.
⁴⁰ Leeds Teaching Hospitals NHS Trust, Leeds, UK.
⁴¹ Department of Clinical Sciences, Anesthesia and Intensive Care, Lund University, Skåne University Hospital, Malmö, Sweden.
⁴² Anesthesia and Intensive Care, Department of Clinical Sciences Lund, Lund University, Skane University Hospital, Lund, Sweden.
⁴³ Department of Anaesthesiology and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden.
⁴⁴ Department of Operation and Intensive Care, Hallands Hospital, Halmstad, Sweden.
⁴⁵ Department of Intensive and Perioperative Care, Skåne University Hospital, Lund University, Lund, Sweden.
⁴⁶ Department of Anaesthesiology and Intensive Care Medicine, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
⁴⁷ Perioperative Medicine and Intensive Care (PMI), Karolinska University Hospital, Stockholm, Sweden.
⁴⁸ Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.
⁴⁹ Function Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden.
⁵⁰ Department of Clinical Science, Interventionand Technology, Karolinska Institute, Stockholm, Sweden.
⁵¹ North Estonia Medical Centre, Tallinn, Estonia.
⁵² Department of Anesthesia and Intensive Care medicine, Division of Emergencies and Critical care, Oslo University Hospital, Oslo, Norway.
⁵³ Lovisenberg Diaconal University College, Oslo, Norway.
⁵⁴ Department of Intensive Care Medicine, Stavanger University Hospital, Stavanger, Norway.
⁵⁵ Department of Anaesthesia and Intensive Care Medicine, Centre Hospitalier de Luxembourg, Luxembourg, Luxembourg.
⁵⁶ Department of Life Sciences and Medicine, Faculty of Science, Technology and Medicine, University of Luxembourg, Esch-sur Alzette, Luxembourg.
⁵⁷ University Heart Center Lübeck, University Hospital Schleswig-Holstein, Schleswig-Holstein, Germany.
⁵⁸ German Center for Cardiovascular Research (DZHK), Hamburg/Lübeck/Kiel, Germany.
⁵⁹ Department of Neurology and Stroke, University Hospital Tuebingen, Hertie Institute of Clinical Brain Research, Tuebingen, Germany.
⁶⁰ Charité-Universitätsmedizin Berlin, Department of Neurology, Freie Universität and Humboldt-Universität zu Berlin, Berlin, Germany.
⁶¹ Department of Nephrology and Medical Intensive Care, Charité-Universitaetsmedizin Berlin, Berlin, Germany.
⁶² Department of Intensive Care Medicine, Ghent University Hospital, Ghent, Belgium.
⁶³ Department of Cardiology, Ziekenhuis Oost-, Genk, Limburg, Belgium.
⁶⁴ University College Dublin Clinical Research Centre at St Vincent's University Hospital, University College Dublin, Dublin, Ireland.
⁶⁵ The Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia.
⁶⁶ The Alfred Hospital, Melbourne, Australia.
⁶⁷ Institute of Intensive Care Medicine University Hospital Zurich, Zurich, Switzerland.
⁶⁸ Institute of Intensive Care Medicine, University Hospital Zurich, Zurich, Switzerland.
⁶⁹ Department of Intensive Care Medicine, Inselspital University Hospital Bern, Bern, Switzerland.
⁷⁰ Klinik für Intensivmedizin, Kantonsspital St. Gallen, St. Gallen, Switzerland.
⁷¹ Istituto Cardiocentro Ticino, Lugano, Switzerland.
⁷² Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Insbruck, Innsbruck, Austria.
⁷³ IRCCS Policlinico San Martino, Genova, Italy. Dipartimento di Scienze Chirurgiche Diagnostiche Integrate, University of Genova, Genova, Italy.
⁷⁴ Anaesthesia and Intensive Care, Pordenone Hospital, Azienda Sanitaria Friuli Occidentale, Pordenone, Italy.
⁷⁵ First Faculty of Medicine, Charles University in Prague, Institute for Heart Diseases, Prauge, Czech Republic.
⁷⁶ Second Department of Internal Medicine, Cardiovascular Medicine, General University Hospital, Wroclaw Medical University, Wroclaw, Poland.
⁷⁷ Second Department of Medicine, Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, Prague, Czech Republic.
⁷⁸ King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
⁷⁹ Department of Anestesia, Critical Care and Pain Medicine, Jaber Alahmad Alsabah Hospital, Kuwait City, Kuwait.
⁸⁰ Tan Tock Seng Hospital, Singapore, Singapore.
⁸¹ Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
⁸² Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.
⁸³ Intensive Care Unit, Liverpool Hospital, South Western Sydney Local Health District, Sydney, New South Wales, Australia.
⁸⁴ South Western Clinical School, University of New South Wales, Sydney, New South Wales, Australia.
⁸⁵ The Ingham Institute for Applied Medical Research, Sydney, New South Wales, Australia.
⁸⁶ Liverpool Hospital, Liverpool, Australia.
⁸⁷ Medical School, University of Queensland, Level 9, Health Sciences Building, Royal Brisbane and Women's Hospital, Brisbane, Australia.
⁸⁸ The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.
⁸⁹ Department of Clinical Medicine, Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, Australia.
⁹⁰ Critical Care Program, The George Institute for Global Health. Malcolm Fisher Depratment of Intensive Care Medicine, Royal North Shore Hospital. Northern Clinical School, Sydney Medical School, University of Sydney, Sydney, Australia.
⁹¹ Caboolture and Royal Brisbane and Women's Hospitals, Metro North Hospital and Health Service, Brisbane, Queensland, Australia.
⁹² School of Clinical Medicine, Queensland University of Technology, Brisbane, Queensland, Australia.
⁹³ Critical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
⁹⁴ Middlemore Hospital, Auckland, New Zealand.
⁹⁵ Department of Intensive Care, Christchurch Hospital, Christchurch Central City, New Zealand.
⁹⁶ Intensive Care Unit, Tampere University Hospital, Tampere, Finland.
⁹⁷ Department of Anaesthesia and Intensive Care, Jorvi Hospital, University Hospital of Helsinki and University of Helsinki, Espoo, Finland.
⁹⁸ Research Unit of Translational Medicine, Research Group of Anaesthesiology, Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.
⁹⁹ OYS Heart, Oulu University Hospital, MRC Oulu and University of Oulu, Oulu, Finland.
¹⁰⁰ Anesthesia and Intensive Care, Department of Clinical Sciences Lund, Lund University, Lund, Sweden.
¹⁰¹ Intensive and Perioperative Care, Skåne University Hospital, Malmö, Sweden.
¹⁰² Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
¹⁰³ Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.

PMID: 40178107
PMCID: PMC11967157
DOI: 10.1111/aas.70022

Comparative Study

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

A Ceric et al. Acta Anaesthesiol Scand. 2025 May.

. 2025 May;69(5):e70022.

doi: 10.1111/aas.70022.

Authors

Affiliations

¹ Anesthesia and Intensive Care, Department of Clinical Sciences, Lund University, Skane University Hospital, Malmö, Sweden.
² Department of Clinical Sciences Lund, Section of Cardiology, Skåne University Hospital, Malmö, Sweden.
³ Faculty of Medicine and Health Technology, Tampere University Hospital, Wellbeing Services County of Pirkanmaa and Tampere University, Tampere, Finland.
⁴ Intensive Care Unit, Wellington Hospital, Wellington, New Zealand.
⁵ Medical Research Institute of New Zealand, Wellington, New Zealand.
⁶ Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia.
⁷ Department of Critical Care, University of Melbourne, Melbourne, Victoria, Australia.
⁸ Department of Anaesthesia and Intensive Care, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
⁹ The George Institute for Global Health, Sydney, Australia.
¹⁰ Royal North Shore Hospital, Sydney, Australia.
¹¹ Critical Care Program, The George Institute for Global Health, UNSW, Sydney, Australia.
¹² Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital, St Leonards, Australia.
¹³ Critical Care Division and Department of Intensive Care Medicine, The George Institute for Global Health and St George Hospital Clinical School, University of New South Wales, Sydney, Australia.
¹⁴ Department of Clinical Sciences Lund, Lund University, Lund, Sweden.
¹⁵ Department of Research, Development, Education and Innovation, Skåne University Hospital, Lund, Sweden.
¹⁶ Neurology, Department of Clinical Sciences Lund, Lund University, Lund, Sweden.
¹⁷ Department of Neurology, Skåne University Hospital, Lund, Sweden.
¹⁸ Department of Neurology and Rehabilitation, Skåne University Hospital, Lund, Sweden.
¹⁹ Department of Neurology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
²⁰ Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland.
²¹ Department of Anaesthesiology and Intensive Care, Kuopio University Hospital, Kuopio, Finland.
²² Department of Clinical Sciences Lund, Anesthesia and Intensive Care, Lund University, Lund, Sweden.
²³ Department of Anesthesia and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden.
²⁴ Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
²⁵ Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.
²⁶ Adult Critical Care, University Hospital of Wales, Cardiff, UK.
²⁷ Wellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast, Belfast, UK.
²⁸ Regional Intensive care Unit, Royal Victoria Hospital, Belfast, United Kingdom.
²⁹ University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
³⁰ Essex Cardiothoracic Centre, MSE NHSFT, Essex, UK.
³¹ Anglia Ruskin School of Medicine & MTRC, ARU, Chelmsford, Essex, United Kingdom.
³² Department of Critical Care, Guy's and St Thomas NHS Foundation Trust, London, UK.
³³ Faculty of Life, Sciences and Medicine, King's College, Intensive Care Medicine, Centre for Human and Applied Physiological Sciences, School of Basic and Medical Biosciences, London, UK.
³⁴ Intensive Care Medicine, King's Critical Care, King's College Hospital, NHS Foundation Trust, London, UK.
³⁵ Department of Pharmacy and Adult Critical Care, Guy's and St Thomas' NHS Foundation Trust, London, UK.
³⁶ Institute of Pharmaceutical Sciences, School of Cancer & Pharmaceutical Sciences, King's College London, London, UK.
³⁷ Critical Care, University Hospital of Wales, Cardiff, UK.
³⁸ BartsHealth NHS Trust, London, UK.
³⁹ Department of Critical Care, Portsmouth University Hospitals Trust, Portsmouth, UK.
⁴⁰ Leeds Teaching Hospitals NHS Trust, Leeds, UK.
⁴¹ Department of Clinical Sciences, Anesthesia and Intensive Care, Lund University, Skåne University Hospital, Malmö, Sweden.
⁴² Anesthesia and Intensive Care, Department of Clinical Sciences Lund, Lund University, Skane University Hospital, Lund, Sweden.
⁴³ Department of Anaesthesiology and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden.
⁴⁴ Department of Operation and Intensive Care, Hallands Hospital, Halmstad, Sweden.
⁴⁵ Department of Intensive and Perioperative Care, Skåne University Hospital, Lund University, Lund, Sweden.
⁴⁶ Department of Anaesthesiology and Intensive Care Medicine, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
⁴⁷ Perioperative Medicine and Intensive Care (PMI), Karolinska University Hospital, Stockholm, Sweden.
⁴⁸ Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.
⁴⁹ Function Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden.
⁵⁰ Department of Clinical Science, Interventionand Technology, Karolinska Institute, Stockholm, Sweden.
⁵¹ North Estonia Medical Centre, Tallinn, Estonia.
⁵² Department of Anesthesia and Intensive Care medicine, Division of Emergencies and Critical care, Oslo University Hospital, Oslo, Norway.
⁵³ Lovisenberg Diaconal University College, Oslo, Norway.
⁵⁴ Department of Intensive Care Medicine, Stavanger University Hospital, Stavanger, Norway.
⁵⁵ Department of Anaesthesia and Intensive Care Medicine, Centre Hospitalier de Luxembourg, Luxembourg, Luxembourg.
⁵⁶ Department of Life Sciences and Medicine, Faculty of Science, Technology and Medicine, University of Luxembourg, Esch-sur Alzette, Luxembourg.
⁵⁷ University Heart Center Lübeck, University Hospital Schleswig-Holstein, Schleswig-Holstein, Germany.
⁵⁸ German Center for Cardiovascular Research (DZHK), Hamburg/Lübeck/Kiel, Germany.
⁵⁹ Department of Neurology and Stroke, University Hospital Tuebingen, Hertie Institute of Clinical Brain Research, Tuebingen, Germany.
⁶⁰ Charité-Universitätsmedizin Berlin, Department of Neurology, Freie Universität and Humboldt-Universität zu Berlin, Berlin, Germany.
⁶¹ Department of Nephrology and Medical Intensive Care, Charité-Universitaetsmedizin Berlin, Berlin, Germany.
⁶² Department of Intensive Care Medicine, Ghent University Hospital, Ghent, Belgium.
⁶³ Department of Cardiology, Ziekenhuis Oost-, Genk, Limburg, Belgium.
⁶⁴ University College Dublin Clinical Research Centre at St Vincent's University Hospital, University College Dublin, Dublin, Ireland.
⁶⁵ The Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia.
⁶⁶ The Alfred Hospital, Melbourne, Australia.
⁶⁷ Institute of Intensive Care Medicine University Hospital Zurich, Zurich, Switzerland.
⁶⁸ Institute of Intensive Care Medicine, University Hospital Zurich, Zurich, Switzerland.
⁶⁹ Department of Intensive Care Medicine, Inselspital University Hospital Bern, Bern, Switzerland.
⁷⁰ Klinik für Intensivmedizin, Kantonsspital St. Gallen, St. Gallen, Switzerland.
⁷¹ Istituto Cardiocentro Ticino, Lugano, Switzerland.
⁷² Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Insbruck, Innsbruck, Austria.
⁷³ IRCCS Policlinico San Martino, Genova, Italy. Dipartimento di Scienze Chirurgiche Diagnostiche Integrate, University of Genova, Genova, Italy.
⁷⁴ Anaesthesia and Intensive Care, Pordenone Hospital, Azienda Sanitaria Friuli Occidentale, Pordenone, Italy.
⁷⁵ First Faculty of Medicine, Charles University in Prague, Institute for Heart Diseases, Prauge, Czech Republic.
⁷⁶ Second Department of Internal Medicine, Cardiovascular Medicine, General University Hospital, Wroclaw Medical University, Wroclaw, Poland.
⁷⁷ Second Department of Medicine, Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, Prague, Czech Republic.
⁷⁸ King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
⁷⁹ Department of Anestesia, Critical Care and Pain Medicine, Jaber Alahmad Alsabah Hospital, Kuwait City, Kuwait.
⁸⁰ Tan Tock Seng Hospital, Singapore, Singapore.
⁸¹ Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
⁸² Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.
⁸³ Intensive Care Unit, Liverpool Hospital, South Western Sydney Local Health District, Sydney, New South Wales, Australia.
⁸⁴ South Western Clinical School, University of New South Wales, Sydney, New South Wales, Australia.
⁸⁵ The Ingham Institute for Applied Medical Research, Sydney, New South Wales, Australia.
⁸⁶ Liverpool Hospital, Liverpool, Australia.
⁸⁷ Medical School, University of Queensland, Level 9, Health Sciences Building, Royal Brisbane and Women's Hospital, Brisbane, Australia.
⁸⁸ The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.
⁸⁹ Department of Clinical Medicine, Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, Australia.
⁹⁰ Critical Care Program, The George Institute for Global Health. Malcolm Fisher Depratment of Intensive Care Medicine, Royal North Shore Hospital. Northern Clinical School, Sydney Medical School, University of Sydney, Sydney, Australia.
⁹¹ Caboolture and Royal Brisbane and Women's Hospitals, Metro North Hospital and Health Service, Brisbane, Queensland, Australia.
⁹² School of Clinical Medicine, Queensland University of Technology, Brisbane, Queensland, Australia.
⁹³ Critical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
⁹⁴ Middlemore Hospital, Auckland, New Zealand.
⁹⁵ Department of Intensive Care, Christchurch Hospital, Christchurch Central City, New Zealand.
⁹⁶ Intensive Care Unit, Tampere University Hospital, Tampere, Finland.
⁹⁷ Department of Anaesthesia and Intensive Care, Jorvi Hospital, University Hospital of Helsinki and University of Helsinki, Espoo, Finland.
⁹⁸ Research Unit of Translational Medicine, Research Group of Anaesthesiology, Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.
⁹⁹ OYS Heart, Oulu University Hospital, MRC Oulu and University of Oulu, Oulu, Finland.
¹⁰⁰ Anesthesia and Intensive Care, Department of Clinical Sciences Lund, Lund University, Lund, Sweden.
¹⁰¹ Intensive and Perioperative Care, Skåne University Hospital, Malmö, Sweden.
¹⁰² Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
¹⁰³ Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.

PMID: 40178107
PMCID: PMC11967157
DOI: 10.1111/aas.70022

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.

Keywords: cardiac arrest; randomized clinical trial; sedation.

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

Affiliations

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

Authors

Affiliations

Abstract

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical