scholarly journals A Valid Warning or Clinical Lore: An Evaluation of Safety Outcomes of Remdesivir in Patients with Impaired Renal Function from a Multicenter Matched Cohort.

Author(s):  
Tyler W. Ackley ◽  
Dayna Mcmanus ◽  
Jeffrey E. Topal ◽  
Brian Cicali ◽  
Sunish Shah

Objective: Per prescribing guidance, remdesivir is not recommended for SARS-CoV-2 in patients with renal disease given the absence of safety data in this patient population. Methods: This study was a multi-center, retrospective chart review of hospitalized patients with SARS-CoV-2 who received remdesivir. Safety outcomes were compared between patients with an estimated creatinine clearance (eCrCl) < 30 mL/min and an eCrCl ≥ 30 mL/min. The primary endpoint was acute kidney injury (AKI) at the end of treatment (EOT). Results: Of 359 patients who received remdesivir, 347 met inclusion criteria. Patients with an eCrCl < 30 mL/min were older [median, 80 years (IQR, 63.8-89) versus 62 (IQR, 54-74); P<0.001], were more likely to be on vasopressors on the day of remdesivir administration (30% versus 12.7%; P=0.003), and were more likely to be mechanically ventilated during remdesivir therapy (27.5% versus 12.4%; P=0.01) compared to those with an eCrCl ≥ 30 mL/min. Despite these confounders, there was no significant difference in the frequency of EOT AKI (5% versus 2.3%; P=0.283) or early discontinuation due to abnormal LFTs (0% versus 3.9%; P=0.374). Of the 5% of patients who developed EOT AKI on remdesivir with an eCrCl <30mL/min, no cases were attributable to remdesivir administration per the treating physician. Comparable safety outcomes were observed when 1:1 nearest neighbor matching was applied to account for baseline confounders. Conclusion: Remdesivir administration was not significantly associated with increased EOT AKI in patients with an eCrCl < 30mL/min compared to patients with an eCrCl ≥ 30mL/min.

2021 ◽  
pp. 088506662110705
Author(s):  
Shan Wang ◽  
Christy Huynh ◽  
Shahidul Islam ◽  
Brian Malone ◽  
Naveed Masani ◽  
...  

Purpose Safety of remdesivir in patients with renal impairment is unknown. Incidence of liver injury secondary to remdesivir is also unknown. The objective of this study is to assess the incidence of acute kidney injury (AKI) and to trend the liver enzymes during remdesivir treatment and change in eGFR from baseline to end of treatment as well as 48 h post completion of remdesivir therapy. Methods This is a retrospective chart review study including adult patients admitted with COVID-19 receiving remdesivir with a baseline eGFR < 30 ml/min per 1.73 m^2 from December 2020 to May 2021. The primary outcome was to assess the incidence of AKI and hepatic injury. The secondary outcome was to assess the efficacy of remdesivir defined by change in oxygen requirement. Results Seventy-one patients were included in the study. Patients experienced an improvement in eGFR from baseline (T0) to end of remdesivir treatment (T1), as well as 48 h after the end of the treatment (T2) ( + 30.3% and + 30.6% respectively, P < .0001). Creatinine reduced from baseline (T0) to T1 and T2 (-20.9% and −20.5% respectively, P < .0001). Creatinine clearance improved from baseline to T1 and T2 ( + 26.6% and + 26.2% respectively, p < .0001). Elevation of aminotransferase (AST) was observed at T1 ( + 2.5%, P  =  .727), however, AST reduction was seen at T2 (-15.8%, P  =  .021). Elevation in alanine transaminase (ALT) was observed at T1 and T2 ( + 25% and + 12%, P  =  .004 and P  =  .137 respectively). Both direct and total bilirubin remained stable and were not significantly changed from baseline. Conclusion Our study showed that remdesivir use in renally-impaired patients with eGFR < 30 ml/min is safe. Remdesivir may be considered as a therapeutic option in this population with COVID-19 infection.


2021 ◽  
pp. 019459982110089
Author(s):  
Quinn Dunlap ◽  
James Reed Gardner ◽  
Amanda Ederle ◽  
Deanne King ◽  
Maya Merriweather ◽  
...  

Objective Neck dissection (ND) is one of the most commonly performed procedures in head and neck surgery. We sought to compare the morbidity of elective ND (END) versus therapeutic ND (TND). Study Design Retrospective chart review. Setting Academic tertiary care center. Methods Retrospective chart review of 373 NDs performed from January 2015 to December 2018. Patients with radical ND or inadequate chart documentation were excluded. Demographics, clinicopathologic data, complications, and sacrificed structures during ND were retrieved. Statistical analysis was performed with χ2 and analysis of variance for comparison of categorical and continuous variables, respectively, with statistical alpha set a 0.05. Results Patients examined consisted of 224 males (60%) with a mean age of 60 years. TND accounted for 79% (n = 296) as compared with 21% (n = 77) for END. Other than a significantly higher history of radiation (37% vs 7%, P < .001) and endocrine pathology (34% vs 2.6%, P < .001) in the TND group, no significant differences in demographics were found between the therapeutic and elective groups. A significantly higher rate of structure sacrifice and extranodal extension within the TND group was noted to hold in overall and subgroup comparisons. No significant difference in rate of surgical complications was appreciated between groups in overall or subgroup analysis. Conclusion While the significantly higher rate of structure sacrifice among the TND population represents an increased morbidity profile in these patients, no significant difference was found in the rate of surgical complications between groups. The significant difference seen between groups regarding history of radiation and endocrine pathology likely represents selection bias.


2021 ◽  
Author(s):  
Jonathan P Scoville ◽  
Evan Joyce ◽  
Joshua Hunsaker ◽  
Jared Reese ◽  
Herschel Wilde ◽  
...  

Abstract BACKGROUND Minimally invasive surgery (MIS) has been shown to decrease length of hospital stay and opioid use. OBJECTIVE To identify whether surgery for epilepsy mapping via MIS stereotactically placed electroencephalography (SEEG) electrodes decreased overall opioid use when compared with craniotomy for EEG grid placement (ECoG). METHODS Patients who underwent surgery for epilepsy mapping, either SEEG or ECoG, were identified through retrospective chart review from 2015 through 2018. The hospital stay was separated into specific time periods to distinguish opioid use immediately postoperatively, throughout the rest of the stay and at discharge. The total amount of opioids consumed during each period was calculated by transforming all types of opioids into their morphine equivalents (ME). Pain scores were also collected using a modification of the Clinically Aligned Pain Assessment (CAPA) scale. The 2 surgical groups were compared using appropriate statistical tests. RESULTS The study identified 43 patients who met the inclusion criteria: 36 underwent SEEG placement and 17 underwent craniotomy grid placement. There was a statistically significant difference in median opioid consumption per hospital stay between the ECoG and the SEEG placement groups, 307.8 vs 71.5 ME, respectively (P = .0011). There was also a significant difference in CAPA scales between the 2 groups (P = .0117). CONCLUSION Opioid use is significantly lower in patients who undergo MIS epilepsy mapping via SEEG compared with those who undergo the more invasive ECoG procedure. As part of efforts to decrease the overall opioid burden, these results should be considered by patients and surgeons when deciding on surgical methods.


2021 ◽  
Author(s):  
Michael H. French ◽  
Michael S. Kung ◽  
W. Nathan Holmes ◽  
Hossein Aziz ◽  
Evelyn S. Thomas ◽  
...  

Abstract BackgroundMany treatment decisions in children’s Orthopaedics are based on age. This study determined whether a discrepancy between chronological age (CA) and skeletal age (SA) is dependent on BMI and if overweight or obese children would have an advanced SA.Materials and Methods120 children between ages 8-17 with an adequate hand radiograph and a correlating BMI were enrolled by retrospective chart review. Stratification based on age, sex, ethnicity, and BMI percentile was performed. For each age group, 6 males and 6 females were selected with 50% of each group having an elevated BMI. Two blinded physicians independently evaluated hand radiographs and recorded the SA. Statistical analyses evaluated inter-rater reliability and any discrepancy between groups.ResultsThe final statistical analysis included 96 children. The Intraclass Correlation Coefficient for SA determined by the two reviewers was excellent at 0.95. A difference of 13 months was found between CA and SA in the elevated BMI cohort versus the non-elevated BMI cohort, (p<0.001). No significant difference was seen between CA and SA for the non-elevated cohort (p=0.72), while matching for age and sex. ConclusionChronological age and skeletal age are not always equivalent especially in pediatric patients who are overweight or obese.


2021 ◽  
Vol 42 (Supplement_1) ◽  
pp. S146-S146
Author(s):  
Loryn Taylor ◽  
Kimberly Maynell ◽  
Thanh Tran ◽  
David J Smith

Abstract Introduction Prolonged opioid usage remains a concern in pain management in procedural care. Recent evidence also suggests that a considerable number of patients who were prescribed opioids struggle with transitioning to non-opioid pain medications. As a continuous effort to reduce opioid consumption following burn surgical procedures, our institution recently evaluated methadone administration for burn procedural care in patients with 20–30% total burn surface area (TBSA) requiring excision and grafting. Methods After IRB approval, we performed a retrospective chart review of patients who underwent excision and grafting procedure for 20–30% TBSA burn injuries between January 1, 2019 and June 30, 2020. The following data was evaluated: postoperative opioid consumption, postoperative pain intensity (rated as “No Pain” [NRS=0], “Minor Pain” [NRS 1 to 3], “Moderate Pain” [NRS 4 to 6], “Severe Pain” [NRS 7 to 10]), time to physical therapy and time to hospital discharge. Data was analyzed using chi square/Fisher exact test for categorical variables and t-test/Wilcoxon rank sum test for continuous variables. Results Our preliminary data included 12 patients who met inclusion criteria, of which two patients received methadone administration. Our patient sample consisted of average age of 43 years, 75% male, and 24% TBSA (92% were flame burns). Patients in both methadone and non-methadone groups had no significant differences in medical histories and TBSA (23% TBSA in methadone, 25% TBSA in non-methadone). There was no significant difference in reported preoperative pain intensity between the two groups, rating moderate to severe. Postoperative pain intensity remained the same, rating moderate to severe and controlled with fentanyl, oxycodone, morphine and non-opioid analgesics. While there was no difference in postoperative fentanyl, opioid and non-opioid analgesic consumptions between the two groups, morphine consumption was significantly lower in the methadone group compared to non-methadone group (2±2 mg vs 51±54 mg, respectively, p=0.02). There was no significant difference between average time from surgery to first physical therapy session and time to hospital discharge (about 21 days after surgery) between the two groups. Conclusions This evaluation shows a potential trend in reduction of inpatient postoperative opioid consumption with the conjunctive administration of methadone, although a bigger sample size is needed for further assessment.


2017 ◽  
Vol 8 (1) ◽  
Author(s):  
Amyna Husain ◽  
M. Douglas Baker ◽  
Mark C. Bisanzo ◽  
Martha W. Stevens

False tooth extraction (FTE), a cultural practice in East Africa used to treat fever and diarrhea in infants, has been thought to increase infant mortality. The mortality of clinically similar infants with and without false tooth extraction has not previously been examined. The objective of our retrospective cohort study was to examine the mortality, clinical presentation, and treatment of infants with and without false tooth extraction. We conducted a retrospective chart review of records of infants with diarrhea, sepsis, dehydration, and fever in a rural Ugandan emergency department. Univariate analysis was used to test statistical significance. We found the mortality of infants with false tooth extraction (FTE+) was 18% and without false tooth extraction (FTE−) was 14% (P=0.22). The FTE+ study group, and FTE− comparison group, had similar proportions of infants with abnormal heart rate and with hypoxia. There was a significant difference in the portion of infants that received antibiotics (P=0.001), and fluid bolus (P=0.002). Although FTE+ infants had clinically similar ED presentations to FTE− infants, the FTE+ infants were significantly more likely to receive emergency department interventions, and had a higher mortality than FTE− infants.


2021 ◽  
pp. 1-6
Author(s):  
Anthony L. Mikula ◽  
Jeremy L. Fogelson ◽  
Soliman Oushy ◽  
Zachariah W. Pinter ◽  
Pierce A. Peters ◽  
...  

OBJECTIVEPelvic incidence (PI) is a commonly utilized spinopelvic parameter in the evaluation and treatment of patients with spinal deformity and is believed to be a fixed parameter. However, a fixed PI assumes that there is no motion across the sacroiliac (SI) joint, which has been disputed in recent literature. The objective of this study was to determine if patients with SI joint vacuum sign have a change in PI between the supine and standing positions.METHODSA retrospective chart review identified patients with a standing radiograph, supine radiograph, and CT scan encompassing the SI joints within a 6-month period. Patients were grouped according to their SI joints having either no vacuum sign, unilateral vacuum sign, or bilateral vacuum sign. PI was measured by two independent reviewers.RESULTSSeventy-three patients were identified with an average age of 66 years and a BMI of 30 kg/m2. Patients with bilateral SI joint vacuum sign (n = 27) had an average absolute change in PI of 7.2° (p < 0.0001) between the standing and supine positions compared to patients with unilateral SI joint vacuum sign (n = 20) who had a change of 5.2° (p = 0.0008), and patients without an SI joint vacuum sign (n = 26) who experienced a change of 4.1° (p = 0.74). ANOVA with post hoc Tukey test showed a statistically significant difference in the change in PI between patients with the bilateral SI joint vacuum sign and those without an SI joint vacuum sign (p = 0.023). The intraclass correlation coefficient between the two reviewers was 0.97 for standing PI and 0.96 for supine PI (p < 0.0001).CONCLUSIONSPatients with bilateral SI joint vacuum signs had a change in PI between the standing and supine positions, suggesting there may be increasing motion across the SI joint with significant joint degeneration.


2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S786-S786
Author(s):  
Krislyn Schweiger ◽  
Henry Donaghy ◽  
Natalie Meirowitz ◽  
Seunjun Ahn ◽  
Thien-Ly Doan

Abstract Background Clindamycin plus gentamicin (C/G) is the most commonly used regimen for the treatment of postpartum endometritis. With a similar spectrum of coverage and once daily dosing, ertapenem is an attractive alternative. The purpose of this study was to evaluate the efficacy of ertapenem compared with C/G, for the treatment of postpartum endometritis. Methods This was a retrospective chart review (IRB-approved) of patients treated with either ertapenem or C/G for endometritis, from July 2017 to July 2018. Patients receiving agents from both groups were excluded. Data collected included: demographics, ante- and intrapartum course, including efficacy parameters and antimicrobial use. Secondary objectives included a safety outcomes and patient quality analysis. Appropriate statistical analysis was performed. Results A total of 81 patients were included (40 in C/G arm, 41 in ertapenem arm). No differences in mean length of stay (5.98 vs. 5.61 days in C/G and ertapenem, P = 0.61), readmission within 14 days, or mortality were seen. No patients developed acute kidney injury, C. difficile infection, or ototoxicity. All patients in the ertapenem arm had appropriate dosing, compared with 27.5% in C/G arm (P < 0.0001). Inappropriate dosing in 79% of C/G group was attributed to under-dosing of gentamicin. For quality measures, patients in C/G arm had more nighttime interruptions (3 vs. 1 interruptions per patient). 46% of patient in the ertapenem group had no overnight interruptions compared with 0% in C/G group. There were 2 suspected wound infections in the C/G group, but none in ertapenem group. Conclusion No difference in efficacy was seen between ertapenem and C/G for treatment of postpartum endometritis Ertapenem was associated with less inappropriate dosing and fewer nighttime interruptions Improvement in patient experience and reduction of nursing workload may outweigh the small additional cost of ertapenem. Disclosures All authors: No reported disclosures.


2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S240-S241
Author(s):  
Olga Kaplun ◽  
Kalie Smith ◽  
Teresa Khoo ◽  
Eric Spitzer ◽  
Fredric Weinbaum ◽  
...  

Abstract Background Human monocytic ehrlichiosis (HME) is a tick-borne disease caused by Ehrlichia chafeensis in the northeast United States. Suffolk County, New York has the highest amount of HME cases in NY (176 from 2010 to 2014). Our aim is to identify risk factors for HME and compare clinical presentation and laboratory findings of young vs. older adults. Methods A retrospective chart review from January 1, 2014 to December 31, 2017 was performed on all patients ≥18 years who presented to the ER at Stony Brook University Hospital (SBUH) or Stony Brook Southampton Hospital (SBSH) with (i) ICD-9 code 082.4 or ICD-10 code A77.40 and (ii) a positive E. Chafeensis PCR. Data were collected on demographics, clinical presentation, and laboratory results. Results Twenty-seven cases of HME were found and separated into Group 1 (G1, n = 10) or Group 2 (G2, n = 17) based on age (Table 1). G1 had a significantly higher chance of being Hispanic than G2. Twenty-four of the 27 patients (89%) were hospitalized with an average length of stay of 3.4 days (range 1–14 days).The only significant difference in clinical presentation was that G1 was more likely to have myalgia (P = 0.02). 40% or more of patients in both groups presented with an acute kidney injury and the average length of hospital stay in days was 4.0 ± 2.9 and 3.2 ± 3.1 for G1 and G2, respectively. The number of cases overall have increased 6.0% per year between 2014 and 2017. Thrombocytopenia presented in all cases. Conclusion. HME is prevalent in Suffolk County. Clinical presentation and laboratory findings were largely similar between the two groups, except the younger population more often presented with myalgia. A risk factor in this study was to be young and Hispanic, likely due to occupational exposure. Disclosures All authors: No reported disclosures.


2009 ◽  
Vol 33 (1) ◽  
pp. 33-40 ◽  
Author(s):  
Sukhinder Bhangu ◽  
Michael Devlin ◽  
Tim Pauley

Objective: To evaluate the functional outcome of individuals with transfemoral and contralateral transtibial amputations secondary to peripheral vascular disease.Methods: A retrospective chart review followed by phone interview. The primary outcome measures were the discharge 2-minute walk test, Frenchay Activities Index, and the Houghton Scale.Results: There were 31 dysvascular individuals identified to have a combination of transfemoral/transtibial (TF/TT) amputation admitted to our institution for rehabilitation from February 1998 to June 2007. The mortality at follow up was 68%. There were eight surviving amputees. The average 2-minute walk test score was 31.9 m at the time of discharge from our inpatient program. Of these, the average Frenchay Activities Index was 15.3. The average Houghton Scale score for use of the transtibial prosthesis alone was 2.1. The average Houghton Scale score for use of both prostheses was 1.5. Comparisons between groups based on initial amputation level revealed a significant difference of being fitted with a transfemoral prosthesis. Those whom initially had a TT amputation were less likely to ultimately be fitted with a TF prosthesis ( X21,n=31 = 4.76, p < 0.05).Conclusion: The overall functional outcome of individuals with a combination of TF/TT amputation due to dysvascular causes is poor. These individuals have a low level of ambulation, activity, and prosthetic use.


Sign in / Sign up

Export Citation Format

Share Document