14 research outputs found
Randomized elimination and prolongation of ACE inhibitors and ARBs in coronavirus 2019 (REPLACE COVID) Trial Protocol
Severe acute respiratory syndrome coronavirus 2 (SARS- CoV- 2), the virus responsible for coronavirus disease 2019 (COVID- 19), is associated with high incidence of multiorgan dysfunction and death. Angiotensin- converting enzyme 2 (ACE2), which facilitates SARS- CoV- 2 host cell entry, may be impacted by angiotensin- converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), two commonly used antihypertensive classes. In a multicenter, international randomized controlled trial that began enrollment on March 31, 2020, participants are randomized to continuation vs withdrawal of their long- term outpatient ACEI or ARB upon hospitalization with COVID- 19. The primary outcome is a hierarchical global rank score incorporating time to death, duration of mechanical ventilation, duration of renal replacement or vasopressor therapy, and multiorgan dysfunction severity. Approval for the study has been obtained from the Institutional Review Board of each participating institution, and all participants will provide informed consent. A data safety monitoring board has been assembled to provide independent oversight of the project.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/163400/2/jch14011_am.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/163400/1/jch14011.pd
Independent Predictors for Hospitalization-Associated Radiation therapy Interruptions
PURPOSE: Radiation treatment interruption associated with unplanned hospitalization remains understudied. The intent of this study was to benchmark the frequency of hospitalization-associated radiation therapy interruptions (HARTI), characterize disease processes causing hospitalization during radiation, identify factors predictive for HARTI, and localize neighborhood environments associated with HARTI at our academic referral center. METHODS AND MATERIALS: This retrospective review of electronic health records provided descriptive statistics of HARTI event rates at our institutional practice. Uni- and multivariable logistic regression models were developed to identify significant factors predictive for HARTI. Causes of hospitalization were established from primary discharge diagnoses. HARTI rates were mapped according to patient residence addresses. RESULTS: Between January 1, 2015, and December 31, 2017, 197 HARTI events (5.3%) were captured across 3729 patients with 727 total missed treatments. The 3 most common causes of hospitalization were malnutrition/dehydration (n = 28; 17.7%), respiratory distress/infection (n = 24; 13.7%), and fever/sepsis (n = 17; 9.7%). Factors predictive for HARTI included African-American race (odds ratio [OR]: 1.48; 95% confidence interval [CI], 1.07-2.06; = .018), Medicaid/uninsured status (OR: 2.05; 95% CI, 1.32-3.15; = .0013), Medicare coverage (OR: 1.7; 95% CI, 1.21-2.39; = .0022), lung (OR: 5.97; 95% CI, 3.22-11.44; \u3c .0001), and head and neck (OR: 5.6; 95% CI, 2.96-10.93; .0001) malignancies, and prescriptions \u3e20 fractions (OR: 2.23; 95% CI, 1.51-3.34; \u3c .0001). HARTI events clustered among Medicaid/uninsured patients living in urban, low-income, majority African-American neighborhoods, and patients from middle-income suburban communities, independent of race and insurance status. Only the wealthiest residential areas demonstrated low HARTI rates. CONCLUSIONS: HARTI disproportionately affected socioeconomically disadvantaged urban patients facing a high treatment burden in our catchment population. A complementary geospatial analysis also captured the risk experienced by middle-income suburban patients independent of race or insurance status. Confirmatory studies are warranted to provide scale and context to guide intervention strategies to equitably reduce HARTI events
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Characteristics and Outcomes of Individuals With Pre-existing Kidney Disease and COVID-19 Admitted to Intensive Care Units in the United States
Underlying kidney disease is an emerging risk factor for more severe coronavirus disease 2019 (COVID-19) illness. We examined the clinical courses of critically ill COVID-19 patients with and without pre-existing chronic kidney disease (CKD) and investigated the association between the degree of underlying kidney disease and in-hospital outcomes.
Retrospective cohort study.
4,264 critically ill patients with COVID-19 (143 patients with pre-existing kidney failure receiving maintenance dialysis; 521 patients with pre-existing non-dialysis-dependent CKD; and 3,600 patients without pre-existing CKD) admitted to intensive care units (ICUs) at 68 hospitals across the United States.
Presence (vs absence) of pre-existing kidney disease.
In-hospital mortality (primary); respiratory failure, shock, ventricular arrhythmia/cardiac arrest, thromboembolic events, major bleeds, and acute liver injury (secondary).
We used standardized differences to compare patient characteristics (values>0.10 indicate a meaningful difference between groups) and multivariable-adjusted Fine and Gray survival models to examine outcome associations.
Dialysis patients had a shorter time from symptom onset to ICU admission compared to other groups (median of 4 [IQR, 2-9] days for maintenance dialysis patients; 7 [IQR, 3-10] days for non-dialysis-dependent CKD patients; and 7 [IQR, 4-10] days for patients without pre-existing CKD). More dialysis patients (25%) reported altered mental status than those with non-dialysis-dependent CKD (20%; standardized difference=0.12) and those without pre-existing CKD (12%; standardized difference=0.36). Half of dialysis and non-dialysis-dependent CKD patients died within 28 days of ICU admission versus 35% of patients without pre-existing CKD. Compared to patients without pre-existing CKD, dialysis patients had higher risk for 28-day in-hospital death (adjusted HR, 1.41 [95% CI, 1.09-1.81]), while patients with non-dialysis-dependent CKD had an intermediate risk (adjusted HR, 1.25 [95% CI, 1.08-1.44]).
Potential residual confounding.
Findings highlight the high mortality of individuals with underlying kidney disease and severe COVID-19, underscoring the importance of identifying safe and effective COVID-19 therapies in this vulnerable population
Randomized elimination and prolongation of ACE inhibitors and ARBs in coronavirus 2019 (REPLACE COVID) Trial Protocol
Severe acute respiratory syndrome coronavirus 2 (SARS- CoV- 2), the virus responsible for coronavirus disease 2019 (COVID- 19), is associated with high incidence of multiorgan dysfunction and death. Angiotensin- converting enzyme 2 (ACE2), which facilitates SARS- CoV- 2 host cell entry, may be impacted by angiotensin- converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), two commonly used antihypertensive classes. In a multicenter, international randomized controlled trial that began enrollment on March 31, 2020, participants are randomized to continuation vs withdrawal of their long- term outpatient ACEI or ARB upon hospitalization with COVID- 19. The primary outcome is a hierarchical global rank score incorporating time to death, duration of mechanical ventilation, duration of renal replacement or vasopressor therapy, and multiorgan dysfunction severity. Approval for the study has been obtained from the Institutional Review Board of each participating institution, and all participants will provide informed consent. A data safety monitoring board has been assembled to provide independent oversight of the project.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/163400/2/jch14011_am.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/163400/1/jch14011.pd
Modeling population density across major US cities: a polycentric spatial regression approach
Population density, Spatial autoregressive model, Monocentric, Polycentric, Spatial autocorrelation,
Continuation versus discontinuation of reninâangiotensin system inhibitors in patients admitted to hospital with COVID-19: a prospective, randomised, open-label trial
Background: Biological considerations suggest that reninâangiotensin system inhibitors might influence the severity of COVID-19. We aimed to evaluate whether continuing versus discontinuing reninâangiotensin system inhibitors (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) affects outcomes in patients admitted to hospital with COVID-19. Methods: The REPLACE COVID trial was a prospective, randomised, open-label trial done at 20 large referral hospitals in seven countries worldwide. Eligible participants were aged 18 years and older who were admitted to hospital with COVID-19 and were receiving a reninâangiotensin system inhibitor before admission. Individuals with contraindications to continuation or discontinuation of reninâangiotensin system inhibitor therapy were excluded. Participants were randomly assigned (1:1) to continuation or discontinuation of their reninâangiotensin system inhibitor using permuted block randomisation, with allocation concealed using a secure web-based randomisation system. The primary outcome was a global rank score in which participants were ranked across four hierarchical tiers incorporating time to death, duration of mechanical ventilation, time on renal replacement or vasopressor therapy, and multiorgan dysfunction during the hospitalisation. Primary analyses were done in the intention-to-treat population. The REPLACE COVID trial is registered with ClinicalTrials.gov, NCT04338009. Findings: Between March 31 and Aug 20, 2020, 152 participants were enrolled and randomly assigned to either continue or discontinue reninâangiotensin system inhibitor therapy (continuation group n=75; discontinuation group n=77). Mean age of participants was 62 years (SD 12), 68 (45%) were female, mean body-mass index was 33 kg/m2 (SD 8), and 79 (52%) had diabetes. Compared with discontinuation of reninâangiotensin system inhibitors, continuation had no effect on the global rank score (median rank 73 [IQR 40â110] for continuation vs 81 [38â117] for discontinuation; ÎČ-coefficient 8 [95% CI â13 to 29]). There were 16 (21%) of 75 participants in the continuation arm versus 14 (18%) of 77 in the discontinuation arm who required intensive care unit admission or invasive mechanical ventilation, and 11 (15%) of 75 participants in the continuation group versus ten (13%) of 77 in the discontinuation group died. 29 (39%) participants in the continuation group and 28 (36%) participants in the discontinuation group had at least one adverse event (Ï2 test of adverse events between treatment groups p=0·77). There was no difference in blood pressure, serum potassium, or creatinine during follow-up across the two groups. Interpretation: Consistent with international society recommendations, reninâangiotensin system inhibitors can be safely continued in patients admitted to hospital with COVID-19. Funding: REPLACE COVID Investigators, REPLACE COVID Trial Social Fundraising Campaign, and FastGrants.Fil: Cohen, Jordana B.. State University of Pennsylvania; Estados UnidosFil: Hanff, Thomas C.. State University of Pennsylvania; Estados UnidosFil: William, Preethi. University of Arizona; Estados UnidosFil: Sweitzer, Nancy. University of Arizona; Estados UnidosFil: Rosado Santander, Nelson R.. Hospital Nacional Carlos Alberto Seguin Escobedo; PerĂșFil: Medina, Carola. Hospital Nacional Edgardo Rebagliati Martins; PerĂșFil: Rodriguez-Mori, Juan E. Hospital Nacional Alberto Sabogal Sologuren; PerĂșFil: Renna, Nicolas Federico. Consejo Nacional de Investigaciones CientĂficas y TĂ©cnicas. Centro CientĂfico TecnolĂłgico Conicet - Mendoza. Instituto de Medicina y BiologĂa Experimental de Cuyo; Argentina. Universidad Nacional de Cuyo; ArgentinaFil: Chang, Tara I.. University of Stanford; Estados UnidosFil: Corrales Medina, Vicente. Ottawa Hospital Research Institute; CanadĂĄFil: Andrade Villanueva, Jaime F.. Hospital Civil de Guadalajara; MĂ©xicoFil: Barbagelata, Alejandro. Pontificia Universidad CatĂłlica Argentina "Santa MarĂa de los Buenos Aires"; Argentina. University of Duke; Estados UnidosFil: Cristodulo Cortez, Roberto. No especifĂca;Fil: DĂaz-Cucho, Omar A. Hospital Alberto Leopoldo Barton Thompson; PerĂșFil: Spaak, Jonas. Danderyd University Hospital; SueciaFil: Alfonso, Carlos E.. University of Miami; Estados UnidosFil: Valdivia Vega, Renzo. Hospital Nacional Edgardo Rebagliati Martins; PerĂșFil: Villavicencio Carranza, Mirko. Hospital Nacional Edgardo Rebagliati Martins; PerĂșFil: Ayala GarcĂa, Ricardo J.. Hospital Nacional Edgardo Rebagliati Martins; PerĂșFil: Castro Callirgos, Carlos A.. Hospital Nacional Edgardo Rebagliati Martins; PerĂșFil: GonzĂĄlez HernĂĄndez, Luz A.. Hospital Civil de Guadalajara; MĂ©xicoFil: Bernales Salas, Eduardo F.. Hospital Nacional Carlos Alberto Seguin Escobedo; PerĂșFil: Coacalla Guerra, Johanna C.. Hospital Nacional Carlos Alberto Seguin Escobedo; PerĂșFil: Salinas Herrera, Cynthia D.. Hospital Nacional Carlos Alberto Seguin Escobedo; PerĂșFil: Nicolosi, Liliana. Hospital Espanol; ArgentinaFil: Basconcel, Mauro. Hospital Espanol; ArgentinaFil: Byrd, James B.. University of Michigan; Estados UnidosFil: Sharkoski, Tiffany. University of Pennsylvania; Estados UnidosFil: BendezĂș Huasasquiche, Luis E.. Hospital Alberto Leopoldo Barton Thompson; PerĂșFil: Chittams, Jesse. University of Pennsylvania; Estados UnidosFil: Edmonston, Daniel L.. University of Duke; Estados UnidosFil: Vasquez, Charles R.. University of Pennsylvania; Estados UnidosFil: Chirinos, Julio A.. University of Pennsylvania; Estados Unido
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Characteristics and Outcomes of Individuals With Pre-existing Kidney Disease and COVID-19 Admitted to Intensive Care Units in the United States
Rationale & objectiveUnderlying kidney disease is an emerging risk factor for more severe coronavirus disease 2019 (COVID-19) illness. We examined the clinical courses of critically ill COVID-19 patients with and without pre-existing chronic kidney disease (CKD) and investigated the association between the degree of underlying kidney disease and in-hospital outcomes.Study designRetrospective cohort study.Settings & participants4,264 critically ill patients with COVID-19 (143 patients with pre-existing kidney failure receiving maintenance dialysis; 521 patients with pre-existing non-dialysis-dependent CKD; and 3,600 patients without pre-existing CKD) admitted to intensive care units (ICUs) at 68 hospitals across the United States.Predictor(s)Presence (vs absence) of pre-existing kidney disease.Outcome(s)In-hospital mortality (primary); respiratory failure, shock, ventricular arrhythmia/cardiac arrest, thromboembolic events, major bleeds, and acute liver injury (secondary).Analytical approachWe used standardized differences to compare patient characteristics (values>0.10 indicate a meaningful difference between groups) and multivariable-adjusted Fine and Gray survival models to examine outcome associations.ResultsDialysis patients had a shorter time from symptom onset to ICU admission compared to other groups (median of 4 [IQR, 2-9] days for maintenance dialysis patients; 7 [IQR, 3-10] days for non-dialysis-dependent CKD patients; and 7 [IQR, 4-10] days for patients without pre-existing CKD). More dialysis patients (25%) reported altered mental status than those with non-dialysis-dependent CKD (20%; standardized difference=0.12) and those without pre-existing CKD (12%; standardized difference=0.36). Half of dialysis and non-dialysis-dependent CKD patients died within 28 days of ICU admission versus 35% of patients without pre-existing CKD. Compared to patients without pre-existing CKD, dialysis patients had higher risk for 28-day in-hospital death (adjusted HR, 1.41 [95% CI, 1.09-1.81]), while patients with non-dialysis-dependent CKD had an intermediate risk (adjusted HR, 1.25 [95% CI, 1.08-1.44]).LimitationsPotential residual confounding.ConclusionsFindings highlight the high mortality of individuals with underlying kidney disease and severe COVID-19, underscoring the importance of identifying safe and effective COVID-19 therapies in this vulnerable population