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OUTpatient intravenous LASix Trial in reducing hospitalization for acute decompensated heart failure (OUTLAST).
Hamo, CE, Abdelmoneim, SS, Han, SY, Chandy, E, Muntean, C, Khan, SA, Sunkesula, P, Meykler, M, Ramachandran, V, Rosenberg, E, et al
PloS one. 2021;(6):e0253014
Abstract
BACKGROUND Hospitalization for acute decompensated heart failure (ADHF) remains a major source of morbidity and mortality. The current study aimed to investigate the feasibility, safety, and efficacy of outpatient furosemide intravenous (IV) infusion following hospitalization for ADHF. METHODS In a single center, prospective, randomized, double-blind study, 100 patients were randomized to receive standard of care (Group 1), IV placebo infusion (Group 2), or IV furosemide infusion (Group 3) over 3h, biweekly for a one-month period following ADHF hospitalization. Patients in Groups 2/3 also received a comprehensive HF-care protocol including bi-weekly clinic visits for dose-adjusted IV-diuretics, medication adjustment and education. Echocardiography, quality of life and depression questionnaires were performed at baseline and 30-day follow-up. The primary outcome was 30-day re-hospitalization for ADHF. RESULTS Overall, a total of 94 patients were included in the study (mean age 64 years, 56% males, 69% African American). There were a total of 14 (15%) hospitalizations for ADHF at 30 days, 6 (17.1%) in Group 1, 7 (22.6%) in Group 2, and 1 (3.7%) in Group 3 (overall p = 0.11; p = 0.037 comparing Groups 2 and 3). Patients receiving IV furosemide infusion experienced significantly greater urine output and weight loss compared to those receiving placebo without any significant increase creatinine and no significant between group differences in echocardiography parameters, KCCQ or depression scores. CONCLUSION The use of a standardized protocol of outpatient IV furosemide infusion for a one-month period following hospitalization for ADHF was found to be safe and efficacious in reducing 30-day re-hospitalization.
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Diabetic retinopathy is independently associated with increased risk of intubation: A single centre cohort study of patients with diabetes hospitalised with COVID-19.
Corcillo, A, Cohen, S, Li, A, Crane, J, Kariyawasam, D, Karalliedde, J
Diabetes research and clinical practice. 2021;:108529
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In our study of 187 patients with diabetes hospitalised with COVID-19 we observed a more than 5 fold increased risk of intubation in patients with diabetic retinopathy. Further studies are required to understand the mechanisms that explain the associations between retinopathy and other indices of microangiopathy with severe COVID-19.
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Prediction of Hypoglycemia During Admission of Non-Critically Ill Patients: Results from the MENU Study.
Khanimov, I, Ditch, M, Adler, H, Giryes, S, Felner Burg, N, Boaz, M, Leibovitz, E
Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme. 2020;(9):660-668
Abstract
The objective of the work was to study admission parameters associated with an increased incidence of hypoglycemia during hospitalization of non-critically ill patients. Included in this cross-sectional study were patients admitted to internal medicine units. The Nutritional Risk Screening 2002 (NRS2002) was used for nutritional screening. Data recorded included admission serum albumin (ASA) and all glucose measurements obtained by the institutional blood glucose monitoring system. Neither of these are included in the NRS2002 metrics. Hypoalbuminemia was defined as ASA<3.5 g/dl. Patients were categorized as hypoglycemic if they had at least one documented glucose≤70 mg/dl during the hospitalization period. Included were 1342 patients [median age 75 years (IQR 61-84), 51.3% male, 52.5% with diabetes mellitus, (DM)], who were screened during three distinct periods of time from 2011-2018. The incidence of hypoglycemia was 10.8% with higher rates among DM patients (14.6 vs. 6.6%, p<0.001). Hypoglycemia incidence was negatively associated with ASA regardless of DM status. Multivariable regression showed that ASA (OR 0.550 per g/dl, 95% CI 0.387-0.781, p=0.001) and positive NRS2002 (OR 1.625, 95% CI 1.072-2.465, p=0.022) were significantly associated with hypoglycemia. The addition of hypoalbuminemia status to the NRS2002 tool improved the overall sensitivity from 0.55 to 0.71, but reduced specificity from 0.63 to 0.46. The negative predictive value was 0.93. Our data suggest that the combination of positive malnutrition screen and hypoalbuminemia upon admission are independently associated with the incidence of hypoglycemia among non-critically ill patients, regardless of diabetes mellitus status.
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Clinical spectrum, etiology and outcome of infectious disease emergencies in adult diabetic patients in northern India.
Pannu, AK, Saroch, A, Singla, V, Sharma, N, Dutta, P, Jain, A, Angrup, A
Diabetes & metabolic syndrome. 2020;(5):921-925
Abstract
BACKGROUND AND AIMS The patients with diabetes mellitus (DM) have an increased incidence of both common and unusual infections. Despite an increasing prevalence of DM in India, local data on the epidemiology and clinical spectrum of associated infections are lacking. We aimed to investigate the spectrum, etiology, and outcome of infectious disorders in adult patients with DM admitted in a medical emergency. METHODS A single-center retrospective observational study conducted between January 2018 to June 2019 in a tertiary care hospital in north India. Based on clinical presentation, radiological features, and microbiological or pathological evidence, 152 diabetic patients aged 12 years and above were diagnosed with the infectious syndrome. RESULTS Urinary tract infection was the most prevalent infectious syndrome (32.2%), followed by pneumonia and empyema (26.3%), skin and soft tissue infections (6.6%), sepsis of unknown primary source (6.6%), pulmonary tuberculosis (4.6%), rhinocerebral infections (4.6%), infectious diarrhea (3.9%), and viral encephalitis (2.6%). The majority of the infections were community-acquired (94.7%). 80.3% of study cases had type 2 DM. The common presenting symptoms were fever (46.1%), dyspnea (27.6%), and altered sensorium (25.7%). Shock and diabetic ketoacidosis were frequent, and each was seen in 27.6% of cases. The mortality rate was 27.6% and was higher with sepsis of unrecognized source (50.0%) and lung infections (30.0%). The presence of shock was the independent predictor of mortality on a multivariant analysis (p-value 0.000). CONCLUSIONS Urinary tract and lung infections remain common in DM. Establishing a microbiological etiology and identification of the source are necessary steps to reduce mortality.
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Prophylactic antibiotics reduce hospitalisations and cost in locally advanced head and neck cancer patients treated with chemoradiotherapy: A randomised phase 2 study.
Ham, JC, Driessen, CM, Hendriks, MP, Fiets, E, Kreike, B, Hoeben, A, Slingerland, M, van Opstal, CC, Kullberg, BJ, Jonker, MA, et al
European journal of cancer (Oxford, England : 1990). 2019;:32-40
Abstract
BACKGROUND Platinum-based chemoradiotherapy for locally advanced head and neck cancer (LAHNC) induces a high rate of acute toxicity, including dysphagia and aspiration pneumonia. We hypothesised that prophylactic antibiotics can prevent pneumonia and hospitalisations and can be cost-effective. PATIENT AND METHODS In this multicentre randomised trial, patients with LAHNC treated with chemoradiotherapy received prophylactic amoxicillin/clavulanic acid from day 29 after the start of treatment until 14 days after completion of chemoradiotherapy or standard care without prophylaxis. The primary objective was to observe a reduction in pneumonias. Secondary objectives were to evaluate the hospitalisation rate, adverse events, costs and health-related quality of life. RESULTS One hundred six patients were included; of which, 95 were randomised: 48 patients were allocated to the standard group and 47 patients to the prophylaxis group. A pneumonia during chemoradiotherapy and follow-up until 3.5 months was observed in 22 (45.8%) of 48 patients in the standard group and in 22 (46.8%) of 47 patients in the prophylaxis group (p = 0.54). Hospitalisation rate was significantly higher in the standard group versus the prophylaxis group, 19 of 48 pts (39.6%) versus 9 of 47 pts (19.1%), respectively (p = 0.03). Significantly more episodes with fever of any grade were observed in the standard group (29.2% vs 10.2%, p = 0.028). A significant difference in costs was found, with an average reduction of €1425 per patient in favour of the prophylaxis group. CONCLUSION Although prophylactic antibiotics during chemoradiotherapy for patients with LAHNC did not reduce the incidence of pneumonias, it did reduce hospitalisation rates and episodes with fever significantly and consequently tended to be cost-effective.
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Gut microbial RNA and DNA analysis predicts hospitalizations in cirrhosis.
Bajaj, JS, Thacker, LR, Fagan, A, White, MB, Gavis, EA, Hylemon, PB, Brown, R, Acharya, C, Heuman, DM, Fuchs, M, et al
JCI insight. 2018;(5)
Abstract
BACKGROUND Cirrhosis is associated with gut microbial changes, but current 16S rDNA techniques sequence both dead and live bacteria. We aimed to determine the rRNA content compared with DNA from the same stool sample to evaluate cirrhosis progression and predict hospitalizations. METHODS Cirrhotics and controls provided stool for RNA and DNA analysis. Comparisons were made between cirrhotics/controls and within cirrhosis (compensated/decompensated, infected/uninfected, renal dysfunction/not, rifaximin use/not) with respect to DNA and RNA bacterial content using linear discriminant analysis. A separate group was treated with omeprazole for 14 days with longitudinal microbiota evaluation. Patients were followed for 90 days for hospitalizations. Multivariable models for hospitalizations with clinical data with and without DNA and RNA microbial data were created. RESULTS Twenty-six controls and 154 cirrhotics (54 infected, 62 decompensated, 20 renal dysfunction, 18 rifaximin) were included. RNA and DNA analysis showed differing potentially pathogenic taxa but similar autochthonous taxa composition. Thirty subjects underwent the omeprazole study, which demonstrated differences between RNA and DNA changes. Thirty-six patients were hospitalized within 90 days. In the RNA model, MELD score and Enterococcus were independently predictive of hospitalizations, while in the DNA model MELD was predictive and Roseburia protective. In both models, adding microbiota significantly added to the MELD score in predicting hospitalizations. CONCLUSION DNA and RNA analysis of the same stool sample demonstrated differing microbiota composition, which independently predicts the hospitalization risk in cirrhosis. RNA and DNA content of gut microbiota in cirrhosis are modulated differentially with disease severity, infections, and omeprazole use. TRIAL REGISTRATION NCT01458990. FUNDING VA Merit I0CX001076.
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Prospective evaluation of integrated device diagnostics for heart failure management: results of the TRIAGE-HF study.
Virani, SA, Sharma, V, McCann, M, Koehler, J, Tsang, B, Zieroth, S
ESC heart failure. 2018;(5):809-817
Abstract
AIMS: The primary aim of the TRIAGE-HF trial was to correlate cardiac implantable electronic device-generated heart failure risk status (HFRS) with signs, symptoms, and patient behaviours classically associated with worsening heart failure (HF). METHODS AND RESULTS TRIAGE-HF enrolled 100 subjects with systolic HF implanted with a Medtronic high-performance device and followed up at three Canadian HF centres. Study follow-up was up to 8 months. The HFRS assigned each subject's overall risk of HF hospitalization in the next 30 days and also highlighted abnormal device parameters contributing to a patient's risk status at the time of remote data transmission. Subjects with a high HFRS were contacted by telephone to assess symptoms, and compliance with prescribed therapies, nutrition, and exercise. Clinician-assessed risk and HFRS-calculated risk were correlated at both study baseline and exit. Twenty-four high HFRS occurrences were observed among 100 subjects. Device parameters associated with increased risk of HF hospitalization included OptiVol index (n = 20), followed by low patient activity (n = 18) and elevated night heart rate (n = 12). High HFRS was associated with symptoms of worsening HF in 63% of cases (n = 15) increasing to 83% of cases (n = 20) when non-compliance with pharmacological therapies and lifestyle was considered. CONCLUSIONS TRIAGE-HF is the first study to provide prospective data on the distribution of abnormal device parameters contributing to high HFRS. High HFRS has good predictive accuracy for patient-reported signs, symptoms, and behaviours associated with worsening HF status. As such, HFRS may be a useful tool for ambulatory HF monitoring to improve both patient-centred and health system level outcomes.
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Rise in BNP despite appropriate acute decompensated heart failure treatment : Patient characteristics and outcomes.
Omar, HR, Guglin, M
Herz. 2017;(4):411-417
Abstract
INTRODUCTION B-type natriuretic peptide (BNP) tends to decrease in response to successful treatment of decompensated heart failure (HF). We identified characteristics and outcomes of patients whose BNP levels rise during admission despite appropriate decongestive therapy. METHODS Patients enrolled in the ESCAPE trial admitted with acute systolic HF were divided into two groups according to whether or not BNP increased during the period from admission (T0) to discharge (T1). The study endpoint was 6‑month all-cause mortality. RESULTS Of 245 patients (age 56 years, 75 % men) admitted with acute systolic HF, 67 (27.3 %) had a higher BNP at T1 relative to T0. Despite similar degrees of congestion at T0, patients with BNP rise at T1 had less degree of decongestion from T0 to T1 as evident in the lower frequency of patients who had resolution of jugular venous distension (39.7 vs. 59.5 %, P = 0.01) and orthopnea (32.2 vs. 48.8 %, P = 0.029) at T1, in addition to lower reduction in IVC diameter during inspiration (P = 0.001) and expiration (P = 0.002) and less weight loss (P = 0.04). Patients with BNP rise at T1 were more likely to die (29.9 vs. 15.7 %, univariate OR 2.28, 95 % CI 1.177-4.414, P = 0.015) despite a lower BNP at T0 (492 vs. 1260 pg/ml, P < 0.001). Cox proportional hazard analysis revealed that a higher BNP at T1 independently predicts 6‑month mortality (hazard ratio 1.95, 95 % CI 1.067-3.578, P = 0.03) after adjustment for age, sodium, creatinine, and NYHA class-all at discharge. Kaplan-Meier analysis comparing survival in patients with or without BNP rise on discharge showed a significant intergroup difference (log-rank P value = 0.017). CONCLUSION Higher BNP levels on discharge identifies a subset of patients with lower degree of decongestion from T0 to T1 and higher 6‑month mortality.
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Gastroesophageal Reflux Burden, Even in Children That Aspirate, Does Not Increase Pediatric Hospitalization.
Duncan, DR, Amirault, J, Johnston, N, Mitchell, P, Larson, K, Rosen, RL
Journal of pediatric gastroenterology and nutrition. 2016;(2):210-7
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OBJECTIVES Gastroesophageal reflux is common but remains a controversial disease to diagnose and treat and little is known about the role of reflux testing in predicting clinical outcomes, particularly in children at risk for extraesophageal reflux complications. The aim of this study was to determine if rates of hospitalization were affected by reflux burden even after adjusting for aspiration risk. METHODS We prospectively recruited, between 2009 and 2014, a cohort of pediatric patients with suspected extraesophageal reflux disease who were referred for reflux testing and underwent both multichannel intraluminal impedance with pH (pH-MII) and modified barium swallow studies. A subset of patients also underwent bronchoalveolar lavage with pepsin analysis. We determined their rates of hospitalization for a minimum of 1 year following pH-MII testing. RESULTS We prospectively enrolled 116 pediatric patients who presented for care at Boston Children's Hospital and underwent both pH-MII and modified barium swallow studies. There was no statistically significant relationship between reflux burden measured by pH-MII or bronchoalveolar pepsin and total number of admissions or number of admission nights even after adjusting for aspiration status (P > 0.2). There were no statistically significant relationships between reflux burden by any method and the number or nights of urgent pulmonary admissions before or after adjusting for aspiration risk (P > 0.08). CONCLUSIONS Even in aspirating children, reflux burden did not increase the risk of hospitalization. Based on these results, routine reflux testing cannot be recommended even in aspirating children, because the results do not impact clinically significant outcomes.
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Efficacy and Long-Term Safety of a Dengue Vaccine in Regions of Endemic Disease.
Hadinegoro, SR, Arredondo-García, JL, Capeding, MR, Deseda, C, Chotpitayasunondh, T, Dietze, R, Muhammad Ismail, HI, Reynales, H, Limkittikul, K, Rivera-Medina, DM, et al
The New England journal of medicine. 2015;(13):1195-206
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BACKGROUND A candidate tetravalent dengue vaccine is being assessed in three clinical trials involving more than 35,000 children between the ages of 2 and 16 years in Asian-Pacific and Latin American countries. We report the results of long-term follow-up interim analyses and integrated efficacy analyses. METHODS We are assessing the incidence of hospitalization for virologically confirmed dengue as a surrogate safety end point during follow-up in years 3 to 6 of two phase 3 trials, CYD14 and CYD15, and a phase 2b trial, CYD23/57. We estimated vaccine efficacy using pooled data from the first 25 months of CYD14 and CYD15. RESULTS Follow-up data were available for 10,165 of 10,275 participants (99%) in CYD14 and 19,898 of 20,869 participants (95%) in CYD15. Data were available for 3203 of the 4002 participants (80%) in the CYD23 trial included in CYD57. During year 3 in the CYD14, CYD15, and CYD57 trials combined, hospitalization for virologically confirmed dengue occurred in 65 of 22,177 participants in the vaccine group and 39 of 11,089 participants in the control group. Pooled relative risks of hospitalization for dengue were 0.84 (95% confidence interval [CI], 0.56 to 1.24) among all participants, 1.58 (95% CI, 0.83 to 3.02) among those under the age of 9 years, and 0.50 (95% CI, 0.29 to 0.86) among those 9 years of age or older. During year 3, hospitalization for severe dengue, as defined by the independent data monitoring committee criteria, occurred in 18 of 22,177 participants in the vaccine group and 6 of 11,089 participants in the control group. Pooled rates of efficacy for symptomatic dengue during the first 25 months were 60.3% (95% CI, 55.7 to 64.5) for all participants, 65.6% (95% CI, 60.7 to 69.9) for those 9 years of age or older, and 44.6% (95% CI, 31.6 to 55.0) for those younger than 9 years of age. CONCLUSIONS Although the unexplained higher incidence of hospitalization for dengue in year 3 among children younger than 9 years of age needs to be carefully monitored during long-term follow-up, the risk among children 2 to 16 years of age was lower in the vaccine group than in the control group. (Funded by Sanofi Pasteur; ClinicalTrials.gov numbers, NCT00842530, NCT01983553, NCT01373281, and NCT01374516.).