{
  "abstract": "Introduction Temperature control is a fundamental intervention for neuroprotection following resuscitation from cardiac arrest. However, evidence regarding the efficacy of hypothermia in post-cardiac arrest syndrome (PCAS) remains unclear. Retrospective studies suggest that the clinical effectiveness of hypothermia may depend on the severity of PCAS. The R-CAST OHCA trial aims to compare the efficacy of hypothermia versus normothermia in improving 30-day neurological outcomes in patients with moderately severe PCAS following out-of-hospital cardiac arrest.Methods and analysis The multicentre, single-blind, parallel-group, superiority, randomised controlled trial (RCT) is conducted with the participation of 35 emergency and critical care centres and/or intensive care units at academic and non-academic hospitals. The study enrols moderately severe PCAS patients, defined as those with a revised post-Cardiac Arrest Syndrome for induced Therapeutic Hypothermia score of 5.5–15.5. A target number of 380 participants will be enrolled. Participants are randomised to undergo either hypothermia or normothermia within 3 hours after return of spontaneous circulation. Patients in the hypothermia group are cooled and maintained at 34°C until 28 hours post-randomisation, followed by rewarming to 37°C at a rate of 0.25°C/hour. Patients in the normothermia group are maintained at normothermia (36.5°C–37.7°C). Total periods of intervention, including the cooling, maintenance and rewarming phases, will occur 40 hours after randomisation. Other treatments for PCAS can be determined by the treating physicians. The primary outcome is a favourable neurological outcome, defined as Cerebral Performance Category 1 or 2 at 30 days after randomisation and compared using an intention-to-treat analysis.Ethics and dissemination This study has been approved by the Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee (approval number: R2201-001). Written informed consent is obtained from all participants or their authorised surrogates. Results will be disseminated via publications and presentations.Trial registration number jRCT1062220035.",
  "authors": [
    {
      "affiliations": [
        "Department of Emergency, Critical Care, and Disaster Medicine, Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences, Okayama, Japan"
      ],
      "name": "Hiromichi Naito"
    },
    {
      "affiliations": [
        "Department of Emergency and Critical Care Medicine, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan",
        "Department of Emergency and Critical Care Medicine, Aichi Medical University, Nagakute, Japan"
      ],
      "name": "Mitsuaki Nishikimi"
    },
    {
      "affiliations": [
        "Department of Preventive Services, School of Public Health, Graduate School of Medicine, Kyoto University, Kyoto, Japan",
        "Health Services and Systems Research, Duke-NUS Medical School, Singapore"
      ],
      "name": "Yohei Okada"
    },
    {
      "affiliations": [
        "Department of Emergency and Critical Care Medicine, Tsuyama Chuo Hospital, Tsuyama, Japan"
      ],
      "name": "Hiroki Maeyama"
    },
    {
      "affiliations": [
        "Division of Trauma and Surgical Critical Care, Osaka General Medical Center, Osaka, Japan"
      ],
      "name": "Takeyuki Kiguchi"
    },
    {
      "affiliations": [
        "Department of Epidemiology, Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences, Okayama, Japan"
      ],
      "name": "Takashi Yorifuji"
    },
    {
      "affiliations": [
        "Department of Biostatistics, School of Public Health, Graduate School of Medicine, Kyoto University, Kyoto, Japan, Kyoto, Japan"
      ],
      "name": "Kazuki Nishida"
    },
    {
      "affiliations": [
        "Department of Biostatistics, School of Public Health, Graduate School of Medicine, Kyoto University, Kyoto, Japan, Kyoto, Japan"
      ],
      "name": "Shigeyuki Matsui"
    },
    {
      "affiliations": [
        "Emergency and Critical Care Center, TMG Asaka Medical Center, Asaka, Japan",
        "Faculty of Medicine, Kagawa University Hospital, Kagawa, Japan"
      ],
      "name": "Yasuhiro Kuroda"
    },
    {
      "affiliations": [
        "Division of Emergency and Critical Care Medicine, Niigata University Graduate School of Medical and Dental Science, Niigata, Japan"
      ],
      "name": "Kei Nishiyama"
    },
    {
      "affiliations": [
        "Department of Preventive Services, School of Public Health, Graduate School of Medicine, Kyoto University, Kyoto, Japan"
      ],
      "name": "Taku Iwami"
    },
    {
      "affiliations": [
        "Department of Emergency, Critical Care, and Disaster Medicine, Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences, Okayama, Japan"
      ],
      "name": "Atsunori Nakao"
    },
    {
      "affiliations": [],
      "name": "JAAM R-CAST OHCA Trial Group"
    }
  ],
  "title": "Neurological outcomes with hypothermia versus normothermia in patients with moderate initial illness severity following resuscitation from out-of-hospital cardiac arrest: protocol for a multicentre randomised controlled trial (R-CAST OHCA)",
  "uid": "c191daf0-c74f-51fa-b4cc-6ddd90523b1a"
}