Dataset Information

A response-adaptive design of initial therapy for emergency department patients with heart failure.

ABSTRACT: Finding safe and effective treatments for acute heart failure syndrome (AHFS) is a high priority. More than 80% of patients with AHFS who present to emergency departments are treated identically with intravenous diuretics, despite recognition of the syndrome's heterogeneity. We hypothesize that matching patient profiles with "personalized" AHFS treatments will improve outcomes. Matching multiple heterogeneous clinical profiles with a number of potentially effective treatments requires an adaptive trial design that can adjust for these complexities. We propose a Bayesian response-adaptive randomization trial design for AHFS patients. Baseline information collected for each patient with AHFS prior to randomization includes blood pressure, renal function, and dyspnea severity. The primary outcome is discharge readiness within 23h of presentation and no unplanned emergency visits or admissions for acute heart failure within 7days of discharge. We use a Bayesian logistic regression model to characterize the association between primary outcome and patient profile. We adaptively randomize patients to one of five treatments, basing the randomization probability on the cumulative data from the ongoing trial and fitting results from the regression model. Simulations show high probability of selecting the best treatment corresponding to the patient's profile while allocating more patients to the efficacious treatments within the trial.

SUBMITTER: Wen S

PROVIDER: S-EPMC5259565 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A response-adaptive design of initial therapy for emergency department patients with heart failure.

Wen Sijin S Ning Jing J Collins Sean S Berry Donald D

Contemporary clinical trials 20161109

Finding safe and effective treatments for acute heart failure syndrome (AHFS) is a high priority. More than 80% of patients with AHFS who present to emergency departments are treated identically with intravenous diuretics, despite recognition of the syndrome's heterogeneity. We hypothesize that matching patient profiles with "personalized" AHFS treatments will improve outcomes. Matching multiple heterogeneous clinical profiles with a number of potentially effective treatments requires an adaptiv ...[more]

PMID: 27838474

Similar Datasets

Project description:BackgroundLoop diuretics are common therapy for emergency department (ED) patients with acute heart failure (AHF). Diuretic resistance (DR) is a term used to describe blunted natriuretic response to loop diuretics. It would be important to detect DR prior to it becoming clinically apparent, so early interventions can be initiated. However, several definitions have been proposed, and it is not clear if they identify similar patients. We compared these definitions and described the clinical characteristics of patients who fulfilled them.MethodsTo qualify for this secondary analysis of 1033 ED patients with AHF, all patients needed to receive intravenous diuretics in the ED and have urine available within 24 h of their ED evaluation. A poor diuretic response, suggesting DR, was characterized by (1) a fractional sodium excretion (FeNa) of less than 0.2%; (2) spot urinary sodium of less than 50 meq/L; and (3) a urinary Na/K ratio <1.0. McNemar's test was used to compare the different cohorts identified by the three definitions. Secondary analyses evaluated associations between each DR definition and hospital length of stay (LOS), ED revisits and rehospitalizations for AHF, and mortality using the Wilcoxon rank-sum tests and linear regression or Pearson chi-square test and logistic regression, as appropriate.ResultsThe median age of the 187 patients was 64, and 50% were African-American. There were 5.9% of patients with a FeNa less than 0.2%, 17.1% had urinary sodium less than 50 meq/L, and 10.7% had a urinary Na/K ratio <1.0. The three definitions identified significantly different patients with very little overlap (p < 0.02 for all comparisons). There were 37 (19.8%) patients who were readmitted to the ED or hospital or died within 30 days of ED evaluation. Patients with spot urinary sodium less than 50 meq/L were more likely to be readmitted (p = 0.03).ConclusionsThe patient proportion with poor natriuresis and DR varies depending on the definition used. Early ED therapy would be impacted at different rates if clinical decisions are made based on these definitions. These findings need to be further explored in a prospective ED-based study.Trial registrationClinicalTrials.gov, NCT00508638.

Project description:IntroductionThe purpose of this study was to validate and assess the performance of the Emergency Heart Failure Mortality Risk Grade (EHMRG) to predict seven-day mortality in US patients presenting to the emergency department (ED) with acute congestive heart failure (CHF) exacerbation.MethodsWe performed a retrospective chart review on patients presenting to the ED with acute CHF exacerbation between January 2014-January 2016 across eight EDs in New York. We identified patients using codes from the International Classification of Diseases, 9th and 10 Revisions, or who were diagnosed with CHF in the ED. Inclusion criteria were patients ≥ 18 years of age who presented to the ED for acute CHF. Exclusion criteria included the following: end-stage renal disease related heart failure; < 18 years of age; pregnancy; palliative care; renal failure; and "do not resuscitate" directive. The primary outcome was seven-day mortality. We used mixed-effects logistic regression models to estimate C-statistics and continuous net reclassification index for events and nonevents.ResultsWe identified 3,320 ED visits associated with suspected CHF among 2,495 unique patients. Of the 3,320 ED visits, 94.7% patients were admitted to the hospital and 3.4% were discharged. The median age was 78.6 (interquartile range 68.01 - 86.76). There was an overall seven-day mortality of 2%, an inpatient mortality rate of 2.4%, and no mortality among the discharge group. Adding EHMRG to the risk prediction model improved the C-statistic (from 0.748 to 0.772) and led to a higher degree of reclassification for both events and nonevents.ConclusionThe EHMRG can be used as a valuable and effective screening tool in the US while considering disposition decision for patients with acute CHF exacerbation. Emergency medical services transport and metolazone use is much higher in the US population as compared to the Canadian population. We observed minimal to no short-term mortality among discharged CHF patients from the ED.

Project description:AimsThis study aimed to assess short-term outcomes among emergency department (ED) patients with acute heart failure (AHF) by preserved (≥50%) vs. reduced (<50%) ejection fraction (EF).Methods and resultsWe conducted a retrospective, multicentre study of adult ED patients with AHF from 2017 to 2018 in an integrated healthcare system with 21 hospitals. Among patients with known EF, our primary outcome was 30 day all-cause mortality, comparing patients with heart failure with preserved EF (HFpEF) and heart failure with reduced EF (HFrEF), adjusted for known risk factors. We ran separate multivariate regression models to compare 30 day mortality between HFpEF and HFrEF patients stratified by ED disposition (admit, observe, and discharge). Our secondary outcomes were adjusted 30 day all-cause return hospital admission and rates of non-fatal serious adverse events, including new intra-aorta balloon pump, endotracheal intubation, renal failure requiring dialysis, myocardial infarction, or coronary revascularization. We conducted a sensitivity analysis among patients with EF ≤ 40% and compared our primary and secondary outcomes among patients with EF ≤ 40% with those with EF ≥ 50%. Among the 26 050 total ED encounters for AHF, 15 275 (58.6%) had known EF and 62.4% had HFpEF. The mean age was 76, 49.6% were women, and 60.5% were white. We found that 62.4% of patients were admitted, 18.3% were observed, and 19.3% were discharged from the ED. The 30 day all-cause mortality rate was lowest among discharged patients (3.9%), intermediate among observed patients (5.9%), and highest among admitted patients (13.9%). Overall, the adjusted 30 day mortality rate was significantly higher among HFpEF patients compared with HFrEF patients (10.2% vs. 8.4%, P = 0.0004). HFpEF patients had higher mortality regardless of ED disposition, although the difference was only significant among admitted patients. The adjusted 30 day return hospital admission rates were not significantly different between HFpEF and HFrEF patients (17.9% vs. 17.8%, P = 0.89). The adjusted 30 day non-fatal serious adverse event rates were significantly higher among HFrEF patients compared with HFpEF patients (13.7% vs. 11.1%, P < 0.0001), driven by myocardial infarction and coronary revascularization. We found that 3692 patients had EF ≤ 40%. Patients with EF ≥ 50% had significantly higher adjusted 30 day mortality rates compared with those with EF ≤ 40% (10.2% vs. 8.4%, P < 0.05).ConclusionIn a contemporary population, almost three quarters of ED patients with AHF and known EF have HFpEF. These patients have higher 30 day adjusted mortality compared with those with HFrEF. Further studies might evaluate the underlying factors associated with this difference and target interventions to improve outcomes.

Dataset Information

A response-adaptive design of initial therapy for emergency department patients with heart failure.

Publications

A response-adaptive design of initial therapy for emergency department patients with heart failure.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets