Dexmedetomidine versus haloperidol for sedation of non-intubated patients with hyperactive delirium during the night in a high dependency unit: study protocol for an open-label, parallel-group, randomized controlled trial (DEX-HD trial).

BACKGROUND: Delirium is common in critically ill patients. Haloperidol has long been used for the treatment of delirium. Dexmedetomidine has recently been used to treat delirium among intubated critically ill patients. However, the efficacy of dexmedetomidine for delirium in non-intubated critically ill patients remains unknown. We hypothesize that dexmedetomidine is superior to haloperidol for sedation of patients with hyperactive delirium, and would reduce the prevalence of delirium among non-intubated patients after administration. We will conduct a randomized controlled trial to compare dexmedetomidine and haloperidol for the treatment of nocturnal hyperactive delirium in non-intubated patients in high dependency units (HDUs). METHODS: This is an open-label, parallel-group, randomized controlled trial to compare the efficacy and safety of dexmedetomidine and haloperidol for nocturnal hyperactive delirium in non-intubated patients at two HDUs of a tertiary hospital. We will recruit consecutive non-intubated patients who are admitted to the HDU from the emergency room, and allocate them in a 1:1 ratio to the dexmedetomidine or haloperidol group in advance. The allocated investigational drug will be administered only when participants develop hyperactive delirium (Richmond Agitation-Sedation Scale [RASS] score ≥1 and a positive score on the Confusion Assessment Method for the ICU between 19:00 and 6:00 the next day) during the night at an HDU. Dexmedetomidine is administered continuously, while haloperidol is administered intermittently. The primary outcome is the proportion of participants who achieve the targeted sedation level (RASS score of between -3 and 0) 2h after the administration of the investigational drug. Secondary outcomes include the sedation level and prevalence of delirium on the day following the administration of the investigational drugs, and safety. We plan to enroll 100 participants who develop nocturnal hyperactive delirium and receive one of the two investigational drugs. DISCUSSION: This is the first randomized controlled trial to compare the efficacy and safety of dexmedetomidine and haloperidol for sedation of non-intubated critically ill patients with hyperactive delirium in HDUs. The results of this study may confirm whether dexmedetomidine could be another option to sedate patients with hyperactive delirium. TRIAL REGISTRATION: Japan Registry of Clinical Trials, jRCT1051220015, registered on 21 April 2022.

Study of the outcome of suicide attempts: characteristics of hospitalization in a psychiatric ward group, critical care center group, and non-hospitalized group.

BACKGROUND: The allocation of outcome of suicide attempters is extremely important in emergency situations. Following categorization of suicidal attempters who visited the emergency room by outcome, we aimed to identify the characteristics and potential needs of each group. METHODS: The outcomes of 1348 individuals who attempted suicide and visited the critical care center or the psychiatry emergency department of the hospital were categorized into 3 groups, "hospitalization in the critical care center (HICCC)", "hospitalization in the psychiatry ward (HIPW)", or "non-hospitalization (NH)", and the physical, mental, and social characteristics of these groups were compared. In addition, multiple logistic analysis was used to extract factors related to outcome. RESULTS: The male-to-female ratio was 1:2. The hospitalized groups, particularly the HICCC group, were found to have biopsychosocially serious findings with regard to disturbance of consciousness (JCS), general health performance (GAS), psychiatric symptoms (BPRS), and life events (LCU), while most subjects in the NH group were women who tended to repeat suicide-related behaviors induced by relatively light stress. The HIPW group had the highest number of cases, and their symptoms were psychologically serious but physically mild. On multiple logistic analysis, outcome was found to be closely correlated with physical severity, risk factor of suicide, assessment of emergent medical intervention, and overall care. CONCLUSION: There are different potential needs for each group. The HICCC group needs psychiatrists on a full-time basis and also social workers and clinical psychotherapists to immediately initiate comprehensive care by a medical team composed of multiple professionals. The HIPW group needs psychological education to prevent repetition of suicide attempts, and high-quality physical treatment and management skill of the staff in the psychiatric ward. The NH group subjects need a support system to convince them of the risks of attempting suicide and to take a problem-solving approach to specific issues.