Efficacy and safety of rapid intermittent correction compared with slow continuous correction with hypertonic saline in patients with moderately severe or severe symptomatic hyponatremia: study protocol for a randomized controlled trial (SALSA trial)

Abstract Background Hyponatremia is the most common electrolyte imbalance encountered in clinical practice, associated with increased mortality and length of hospital stay. However, no high-quality evidence regarding whether hypertonic saline is best administered as a continuous infusion or a bolus injection has been found to date. Therefore, in the current study, we will evaluate the efficacy and safety of rapid intermittent correction compared with slow continuous correction with hypertonic saline in patients with moderately severe or severe symptomatic hyponatremia. Methods/design This is a prospective, investigator-initiated, multicenter, open-label, randomized controlled study with two experimental therapy groups. A total of 178 patients with severe symptomatic hyponatremia will be enrolled and randomly assigned to receive either rapid intermittent bolus or slow continuous infusion management with hypertonic saline. The primary outcome is the incidence of overcorrection at any given period over 2 days. The secondary outcomes will include the efficacy and safety of two other approaches to the treatment of hyponatremia with 3% hypertonic saline. Discussion This is the first clinical trial to investigate the efficacy and safety of rapid intermittent correction compared with slow continuous correction with hypertonic saline in patients with moderately severe or severe hyponatremia. Trial registration ClinicalTrials.gov, identifier number: NCT02887469 . Registered on 1 August 2016

Quick Sepsis-related Organ Failure Assessment score is not sensitive enough to predict 28-day mortality in emergency department patients with sepsis: a retrospective review

Objective To test the hypothesis that the quick Sepsis-related Organ Failure Assessment (qSOFA) score, derived from vital signs taken during triage and recommended by current sepsis guidelines for screening patients with infections for organ dysfunction, is not sensitive enough to predict the risk of mortality in emergency department (ED) sepsis patients. Methods Patients diagnosed with severe sepsis and septic shock using the old definition between May 2014 and April 2015 were retrospectively reviewed in three urban tertiary hospital EDs. The sensitivities of systemic inflammatory response syndrome (SIRS) criteria, qSOFA, and Sequential Organ Failure Assessment (SOFA) scores ≥2 were compared using McNemar’s test. Diagnostic performances were evaluated using specificity, positive predictive value, and negative predictive value. Results Among the 928 patients diagnosed with severe sepsis or septic shock using the old definition, 231 (24.9%) died within 28 days. More than half of the sepsis patients (493/928, 53.1%) and more than one-third of the mortality cases (88/231, 38.1%) had a qSOFA score <2. The sensitivity of a qSOFA score ≥2 was 61.9%, which was significantly lower than the sensitivity of SIRS ≥2 (82.7%, P<0.001) and SOFA ≥2 (99.1%, P<0.001). The specificity, positive predictive value, and negative predictive value of a qSOFA score ≥2 for 28-day mortality were 58.1%, 32.9%, and 82.2%, respectively. Conclusion The current clinical criteria of the qSOFA are less sensitive than the SIRS assessment and SOFA to predict 28-day mortality in ED patients with sepsis

SEALONE (Safety and Efficacy of Coronary Computed Tomography Angiography with Low Dose in Patients Visiting Emergency Room) trial: study protocol for a randomized controlled trial

Objective Chest pain is one of the most common complaints in the emergency department (ED). Cardiac computed tomography angiography (CCTA) is a frequently used tool for the early triage of patients with low- to intermediate-risk acute chest pain. We present a study protocol for a multicenter prospective randomized controlled clinical trial testing the hypothesis that a low-dose CCTA protocol using prospective electrocardiogram (ECG)-triggering and limited-scan range can provide sufficient diagnostic safety for early triage of patients with acute chest pain. Methods The trial will include 681 younger adult (aged 20 to 55) patients visiting EDs of three academic hospitals for acute chest pain or equivalent symptoms who require further evaluation to rule out acute coronary syndrome. Participants will be randomly allocated to either low-dose or conventional CCTA protocol at a 2:1 ratio. The low-dose group will undergo CCTA with prospective ECG-triggering and restricted scan range from sub-carina to heart base. The conventional protocol group will undergo CCTA with retrospective ECG-gating covering the entire chest. Patient disposition is determined based on computed tomography findings and clinical progression and all patients are followed for a month. The primary objective is to prove that the chance of experiencing any hard event within 30 days after a negative low-dose CCTA is less than 1%. The secondary objectives are comparisons of the amount of radiation exposure, ED length of stay and overall cost. Results and Conclusion Our low-dose protocol is readily applicable to current multi-detector computed tomography devices. If this study proves its safety and efficacy, dose-reduction without purchasing of expensive newer devices would be possible

High cholesterol concentrations as well as low cholesterol concentrations are associated with mortality at 28 days in sepsis: a retrospective cohort study

Background: Low serum cholesterol is known to be associated with poor prognosis in sepsis patients. On the other hand, there have been few studies on the association between high serum cholesterol, one of the major risk factors for cardiovascular adverse events, and prognosis of sepsis patients. We investigated the relationship between the serum total cholesterol concentration and outcome of sepsis patients. Methods: We conducted a multicenter retrospective cohort study at the emergency departments (EDs) of three urban tertiary teaching hospitals. Patients were divided into three groups according to the initial serum total cholesterol concentration: low cholesterol (cholesterol &lt;120 mg/dL), normal cholesterol (cholesterol 120-200 mg/dL), and high cholesterol (cholesterol &gt; 200 mg/dL). Multivariable Cox proportional hazard regression model was used to identify the independent association between the serum total cholesterol concentrations and mortality at 28 days. Results: A total of 4,512 patients were included in the final analysis. The mortality at 28 days of the low, normal, and high cholesterol groups were 24.1%, 14.5%, and 20.5%, respectively (P&lt;0.001). Both the low and high cholesterol groups had a higher risk of death than the normal cholesterol group (low cholesterol group [hazard ratio (HR), 1.46; 95% confidence interval (CIs), 1.25-1.71] and high cholesterol group (HR, 1.57; 95% CI, 1.14-2.16). Conclusions: Both low and high serum total cholesterol concentrations were associated with higher mortality at 28 days in sepsis patients.N

Outcomes of hanging-induced cardiac arrest patients who underwent therapeutic hypothermia: A multicenter retrospective cohort study

Objectives The aim of this study was to analyze the outcomes of patients with hanging-induced cardiac arrest who underwent therapeutic hypothermia (TH). Method In this multicenter, retrospective registry-based study, discharged patients after out-of-hospital cardiac arrest and treatment with TH were enrolled between June 2007 and March 2013. Several prehospital and hospital variables were examined for an outcome analysis with multivariable logistic regression. Results A total of 964 patients who had cardiac arrest were enrolled in this study. All patients underwent TH during post-cardiac arrest care after return of spontaneous circulation (ROSC). Of all patients, 105 were assigned to the hanging group and 859 to the non-hanging group. Six patients (6%) with good neurologic outcomes (Cerebral Performance Category 1 or 2) in the hanging group at the time of discharge were found. A shorter time interval between witnessed arrest and ROSC and a Glasgow Coma Scale over 4 after ROSC are statistically significant variables of good neurologic outcomes after hanging-induced cardiac arrest treated with TH. Conclusion A small number of patients who underwent TH after a hanging-induced cardiac arrest provided good neurologic outcomes, and some variables influenced these outcomes.OAIID:RECH_ACHV_DSTSH_NO:220142014020983002RECH_ACHV_FG:RR00200001ADJUST_YN:EMP_ID:A080158CITE_RATE:4.167DEPT_NM:의학과EMAIL:[email protected]_YN:YCONFIRM:

Prognostication of cardiac arrest survivors using low apparent diffusion coefficient cluster volume

Introduction We developed a new neuroprognostication method for cardiac arrest (CA) using the relative volume of the most dominant cluster of low apparent diffusion coefficient (ADC) voxels and tested its performance in a multicenter setting. Methods Adult (>15 years) out-of-hospital CA patients from three different facilities who underwent an MRI 12 h after resuscitation were retrospectively analyzed. Patients with unknown long-term prognosis or poor baseline neurologic function were excluded. Average ADCs (mean and median), LADCV (relative volume of low-ADC voxels) and DC-LADCV (relative volume of most dominant cluster of low-ADC voxels) were extracted using different thresholds between 400 and 800 × 10−6 mm2 s−1 at 10 × 10−6 mm2 s−1 intervals. Area under the receiver operating characteristic curve (AUROC) and sensitivity for poor outcome (6-month cerebral performance category score >2) while maintaining 100% specificity were measured. Results 110 patients were analyzed. Average ADCs showed fair performance with an AUROC of 0.822 (95% confidence interval [CI], 0.744–0.900) for the mean and 0.799 (95% CI, 0.716–0.882) for the median. LADCV showed better performance with a higher AUROC (maximum, 0.925) in an ADC threshold range of 400 to 690 × 10−6 mm2 s−1. DC-LADCV showed the best performance with a higher AUROC (maximum, 0.955) compared with LADCV in an ADC threshold range of 600 to 680 × 10−6 mm2 s−1. DC-LADCV had a high sensitivity for poor outcomes (>80%) in a wide threshold range from 400 to 580 × 10−6 mm2 s−1 with a maximum of 89.2%. Conclusions Quantitative analysis using DC-LADCV showed impressive performance in determining the prognosis of out-of-hospital CA patients in a multicenter setting.OAIID:RECH_ACHV_DSTSH_NO:220162014020983001RECH_ACHV_FG:RR00200001ADJUST_YN:EMP_ID:A080158CITE_RATE:5.414DEPT_NM:의학과EMAIL:[email protected]_YN:YCONFIRM: