Early restricted oxygen therapy after resuscitation from cardiac arrest (ER-OXYTRAC): protocol for a stepped-wedge cluster randomised controlled trial.

INTRODUCTION: Cardiac arrest is a critical condition, and patients often experience postcardiac arrest syndrome (PCAS) even after the return of spontaneous circulation (ROSC). Administering a restricted amount of oxygen in the early phase after ROSC has been suggested as a potential therapy for PCAS; however, the optimal target for arterial partial pressure of oxygen or peripheral oxygen saturation (SpO2) to safely and effectively reduce oxygen remains unclear. Therefore, we aimed to validate the efficacy of restricted oxygen treatment with 94%-95% of the target SpO2 during the initial 12 hours after ROSC for patients with PCAS. METHODS AND ANALYSIS: ER-OXYTRAC (early restricted oxygen therapy after resuscitation from cardiac arrest) is a nationwide, multicentre, pragmatic, single-blind, stepped-wedge cluster randomised controlled trial targeting cases of non-traumatic cardiac arrest. This study includes adult patients with out-of-hospital or in-hospital cardiac arrest who achieved ROSC in 39 tertiary centres across Japan, with a target sample size of 1000. Patients whose circulation has returned before hospital arrival and those with cardiac arrest due to intracranial disease or intoxication are excluded. Study participants are assigned to either the restricted oxygen (titration of a fraction of inspired oxygen with 94%-95% of the target SpO2) or the control (98%-100% of the target SpO2) group based on cluster randomisation per institution. The trial intervention continues until 12 hours after ROSC. Other treatments for PCAS, including oxygen administration later than 12 hours, can be determined by the treating physicians. The primary outcome is favourable neurological function, defined as cerebral performance category 1-2 at 90 days after ROSC, to be compared using an intention-to-treat analysis. ETHICS AND DISSEMINATION: This study has been approved by the Institutional Review Board at Keio University School of Medicine (approval number: 20211106). Written informed consent will be obtained from all participants or their legal representatives. Results will be disseminated via publications and presentations. TRIAL REGISTRATION NUMBER: UMIN Clinical Trials Registry (UMIN000046914).

Fluid resuscitation of at least 30 mL/kg was not associated with decreased mortality in patients with infection, signs of hypoperfusion, and a do-not-intubate order.

Aim: Administration of at least 30 mL/kg of fluid as fluid resuscitation is recommended for patients with sepsis and signs of hypoperfusion. However, it is not clear whether this is appropriate for patients with a do-not-intubate (DNI) order. This study evaluated the association between volume of fluid resuscitation and outcomes in patients with infection, signs of hypoperfusion, and a DNI order in an emergency department. Methods: This was a single-center retrospective cohort study. We classified the infected patients with signs of hypoperfusion and a DNI order seen in our emergency department between April 1, 2015 and November 31, 2020 into the standard fluid resuscitation group (≥30 mL/kg) and the restricted fluid resuscitation group (<30 mL/kg). We compared with in-hospital mortality and the rate of discharge to home in two groups. Results: Of 367 patients, 149 received standard fluid resuscitation and 218 received restricted fluid resuscitation. In-hospital mortality was similar in each group (40/149 and 62/218, respectively). Standard fluid resuscitation was not associated with in-hospital mortality (adjusted odds ratio [aOR], 1.05; 95% confidence interval [CI], 0.62-1.77, P = 0.86), but was associated with a significantly lower rate of discharge to home (aOR, 0.55; 95% CI, 0.30-0.98, P = 0.043). There was no significant difference in respiratory rate or need for oxygen therapy post-resuscitation between the two groups. Conclusion: This study suggests that fluid resuscitation may be not beneficial for infected patients with signs of hypoperfusion and a DNI order. Further studies should be conducted on the options for resuscitation management for these patients.

Fatty liver on computed tomography scan on admission is a risk factor for severe coronavirus disease.

OBJECTIVES: To alleviate the overflow of coronavirus disease 2019 (COVID-19) patients in hospitals, less invasive and simple criteria are required to triage the patients. We evaluated the relationship between COVID-19 severity and fatty liver on plain computed tomography (CT) scan performed on admission. METHODS: In this retrospective cohort study, we considered all COVID-19 patients at a large tertiary care hospital between January 31 and August 31, 2020. COVID-19 severity was categorized into severe (moderate and severe) and non-severe (asymptomatic and mild) groups, based on the Japanese National COVID-19 guidelines. Fatty liver was detected on plain CT scan. Multivariate logistic regression analysis was performed to evaluate factors associated with severe COVID-19. RESULTS: Of 222 patients (median age: 52 years), 3.2%, 58.1%, 20.7%, and 18.0% presented with asymptomatic, mild, moderate, and severe COVID-19, respectively. Although 59.9% had no fatty liver on plain CT, mild, moderate, and severe fatty liver occurred in 13.1%, 18.9%, and 8.1%, respectively. Age and presence of fatty liver were significantly associated with severe COVID-19. CONCLUSION: Our study showed that fatty liver on plain CT scan on admission can become a risk factor for severe COVID-19. This finding may help clinicians to easily triage COVID-19 patients.

Metoclopramide versus sumatriptan in the treatment of migraine in the emergency department: a single-center, open-label, cluster-randomized controlled non-inferiority trial.

Migraine is a common disease seen in the emergency department (ED). Triptans, which are recommended in therapeutic guidelines for migraine, have some contraindications and possible severe side effects. Metoclopramide, which is commonly used as an antiemetic, also seems to have pain-relieving effects for migraine. In this article, we will introduce a study in progress, which investigates whether metoclopramide 10 mg intravenously (IV) is non-inferior to sumatriptan 3 mg subcutaneously (SQ) as migraine treatment in the ED. This study is a single-center, open-label, cluster-randomized controlled trial of 80 patients with migraine attacks to investigate the non-inferiority of metoclopramide to sumatriptan. The patients will be cluster-randomized monthly into metoclopramide 10 mg IV and sumatriptan 3 mg SQ arms. The primary outcome will be change in Numerical Rating Scale score for headache at 1 h after baseline. In discussion, if our hypothesis is confirmed, metoclopramide can be considered as first-line medication for migraine attacks in ED settings.

[Predictive Factors for Gastrointestinal Bleeding Following Hemorrhagic Stroke: A Hospital-Based Cohort Study].

BACKGROUND AND PURPOSE: Gastrointestinal bleeding is an important complication in the acute phase of hemorrhagic stroke. In this study, we aimed to identify the risk factors for gastrointestinal bleeding in patients with hemorrhagic stroke despite the administration of antiulcer drugs. METHODS: We conducted a retrospective cohort study of our hemorrhagic stroke cases. We analyzed the background factors associated with gastrointestinal bleeding in the study population and their outcomes. RESULTS: The study included 837 patients: 598 with intracerebral hemorrhages and 239 with subarachnoid hemorrhages. Among them, 22 patients developed gastrointestinal bleeding. Intraventricular hemorrhage (P=0.0019) and ongoing oral anticoagulant use (P=0.0177) were significantly associated with gastrointestinal bleeding. Gastrointestinal bleeding was significantly associated with severe disability at discharge (P=0.0333) and number of days of hospitalization (P=0.0190). CONCLUSIONS: The risk factors of poorly controlled gastrointestinal bleeding during the acute phase of hemorrhagic strokes were intraventricular hemorrhage and use of anticoagulant drugs. Patients with a high risk for gastrointestinal bleeding need to be identified and to be given effective prophylactic therapy. (Received October 12, 2017; Accepted March 29, 2018; Published August 1, 2018).

Survey of second-trimester maternal serum screening in Japan.

AIM: Second-trimester maternal serum screening (MSS) is the predominant form of prenatal screening in Japan. We hypothesize that patient education and physician knowledge of Down syndrome (DS) screening are insufficient to provide adequate information regarding prenatal screening in Japan. MATERIAL AND METHODS: In-person or telephone interviews with medical personnel were conducted at 25 medical facilities utilizing Afp(4) (Esoterix Genetic Laboratories, LLC, a wholly-owned subsidiary of Laboratory Corporation of America Holdings) second trimester screening. We explored how medical facilities provided information about the MSS process to pregnant women. RESULTS: Before prenatal testing, 60% of medical facilities spent an average of less than 5 min per patient explaining the MSS process. The option of amniocentesis for chromosomal aneuploidy was explained at nearly all facilities, but only 60% explained the risk of amniocentesis. Ultrasound examination for open neural tube defects was explained only at half the facilities. Only five of 25 (20%) medical practitioners explained the possibility of having congenital disorders fetus. CONCLUSION: This study revealed that most obstetricians in Japan do not provide their patients with sufficient information about MSS.