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Short-term safety and effectiveness of sugammadex for surgical patients with end-stage renal disease: a two-centre retrospective study.

ABSTRACT: Sugammadex is a novel reversal agent for aminosteroid neuromuscular blocking drugs, especially rocuronium. Given its renal excretion, sugammadex is not recommended for patients with end-stage renal disease; however, reports exist of its use in this group of patients. This two-institutional retrospective observational study aimed to review the safety profile and effectiveness of sugammadex in surgical patients with end-stage renal disease who required pre-operative renal replacement therapy. Adult surgical patients with end-stage renal disease requiring pre-operative renal replacement therapy, who received sugammadex between April 2016 and January 2019, were studied. The primary outcome was the incidence of postoperative tracheal re-intubation within 48 h. The secondary outcome was the incidence of deferred tracheal extubation in the operating theatre. One hundred and fifty-eight patients were identified from 125,653 surgical patients: 48 patients (30%) underwent renal transplantation and 110 (70%) underwent non-renal transplantation procedures. There were 22 instances (14%) of deferred tracheal extubation due to surgical and/or pre-existing medical conditions. Out of the 136 patients who had the tracheal tube removed at the end of the procedure, three patients had their trachea re-intubated within 48 h: two patients developed pulmonary oedema resulting from volume overload; and one patient had worsening sepsis. No incidence of recurrence of neuromuscular blockade was observed. Of note, 24 (18%) patients were found to have incomplete neuromuscular blockade reversal with neostigmine but administration of sugammadex led to successful tracheal extubation. In conclusion, sugammadex appears to be safe and effective in adult patients with end-stage renal disease receiving pre-operative renal replacement therapy.

SUBMITTER: Adams DR

PROVIDER: S-EPMC7004885 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Short-term safety and effectiveness of sugammadex for surgical patients with end-stage renal disease: a two-centre retrospective study.

Adams D R DR Tollinche L E LE Yeoh C B CB Artman J J Mehta M M Phillips D D Fischer G W GW Quinlan J J JJ Sakai T T

Anaesthesia 20191112 3

Sugammadex is a novel reversal agent for aminosteroid neuromuscular blocking drugs, especially rocuronium. Given its renal excretion, sugammadex is not recommended for patients with end-stage renal disease; however, reports exist of its use in this group of patients. This two-institutional retrospective observational study aimed to review the safety profile and effectiveness of sugammadex in surgical patients with end-stage renal disease who required pre-operative renal replacement therapy. Adul ...[more]

PMID: 31721151

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Project description:Background and Objectives: Sugammadex is widely used in anesthesia to reverse rocuronium-induced neuromuscular blockade (NMB). In patients with compromised kidney function, most drugs show alteration of their pharmacokinetic profile with reduced clearance. The purpose of this article is to examine the efficacy, pharmacokinetics, and safety of sugammadex in end-stage renal disease (ESRD) patients receiving general anesthesia, using a systematic review. Materials and Methods: The databases of PubMed, EMBASE, the Cochrane Library, Web of Science, Scopus, KoreaMed, and ClinicalTrials.gov were searched for studies comparing the efficacy or safety outcomes of sugammadex administration for the reversal of rocuronium-induced NMB, in ESRD patients (group R) or in those with normal renal function (group N) undergoing surgery under general anesthesia. Results: We identified nine studies with 655 patients-six prospective, case-control studies with 179 patients (89 and 90 in groups R and N) and three retrospective observational studies with 476 ESRD patients. In the six prospective studies, the times taken to reach a train-of-four ratio ≥0.9, 0.8, and 0.7 were significantly longer in group R than in group N (weighted mean difference [95% confidence interval] [min]: 1.14 [0.29 to 2.00], 0.9 [0.24 to 1.57], 0.89 [0.20 to 1.57], respectively). The total plasma clearance of sugammadex was significantly lower in group R than in group N. There was no significant difference in the incidence of NMB recurrence and prolonged time to recovery between the groups. In the three retrospective studies, the possibility of sugammadex-related adverse events appears to be insignificant. Conclusions: Sugammadex may effectively and safely reverse rocuronium-induced NMB in patients with ESRD, although the recovery to a TOF ratio of 0.9 may be prolonged compared to patients with normal renal function. Further studies are needed, considering the small number of studies included and the high heterogeneity of some of the results.

Project description:BackgroundEvidence is lacking to inform providers' and patients' decisions about many common treatment strategies for patients with end stage renal disease (ESRD).Methods/designThe DEcIDE Patient Outcomes in ESRD Study is funded by the United States (US) Agency for Health Care Research and Quality to study the comparative effectiveness of: 1) antihypertensive therapies, 2) early versus later initiation of dialysis, and 3) intravenous iron therapies on clinical outcomes in patients with ESRD. Ongoing studies utilize four existing, nationally representative cohorts of patients with ESRD, including (1) the Choices for Healthy Outcomes in Caring for ESRD study (1041 incident dialysis patients recruited from October 1995 to June 1999 with complete outcome ascertainment through 2009), (2) the Dialysis Clinic Inc (45,124 incident dialysis patients initiating and receiving their care from 2003-2010 with complete outcome ascertainment through 2010), (3) the United States Renal Data System (333,308 incident dialysis patients from 2006-2009 with complete outcome ascertainment through 2010), and (4) the Cleveland Clinic Foundation Chronic Kidney Disease Registry (53,399 patients with chronic kidney disease with outcome ascertainment from 2005 through 2009). We ascertain patient reported outcomes (i.e., health-related quality of life), morbidity, and mortality using clinical and administrative data, and data obtained from national death indices. We use advanced statistical methods (e.g., propensity scoring and marginal structural modeling) to account for potential biases of our study designs. All data are de-identified for analyses. The conduct of studies and dissemination of findings are guided by input from Stakeholders in the ESRD community.DiscussionThe DEcIDE Patient Outcomes in ESRD Study will provide needed evidence regarding the effectiveness of common treatments employed for dialysis patients. Carefully planned dissemination strategies to the ESRD community will enhance studies' impact on clinical care and patients' outcomes.

Project description:IntroductionEnd-stage renal disease (ESRD) is associated with an increased propensity for critical illness, but whether ESRD is independently associated with a greater risk of death after major surgical procedures is unclear.MethodsThis was a retrospective analysis of prospectively collected data from all adult (>18 years) patients admitted to a 50-bed surgical intensive care unit (ICU) between January 2004 and January 2009. ESRD was defined as the need for chronic peritoneal dialysis or hemodialysis for at least 6 weeks prior to ICU admission. We used multivariable logistic regression analysis and propensity-score matching to adjust for possible confounders.ResultsIn total, 12,938 adult patients were admitted during the study period; 199 patients had ESRD at ICU admission, giving a prevalence of 1.5%. Patients with ESRD were more likely to be male (72.9% versus 63.0%, P?=?0.004) and had higher severity scores, a higher incidence of diabetes mellitus and cirrhosis, and a lower incidence of cancer at ICU admission than those without ESRD. Patients with ESRD were more likely to have any type of organ failure at ICU admission and during the ICU stay. Patients with ESRD had higher ICU and hospital mortality rates (23.1% and 31.2% versus 5.5% and 10.0%, respectively, P <0.001 pairwise) and longer ICU length of stay (2 (1 to 7) versus 1 (1 to 3) days, P <0.001). In multivariable logistic regression analysis, ESRD was independently associated with a greater risk of in-hospital death (odds ratio?=?3.84, 95% confidence interval 2.68 to 5.5, P <0.001). In 199 pairs of patients, hematologic and hepatic failures were more prevalent, ICU and hospital mortality rates were higher (23.1% versus 15.1% and 31.2% versus 19.1%, P <0.05 pairwise), and ICU length of stay was longer (2 (1 to 7) versus 1 (1 to 7) days, P <0.001) in patients with ESRD.ConclusionsIn this large cohort of surgical ICU patients, presence of ESRD at ICU admission was associated with greater morbidity and mortality and independently associated with a greater risk of in-hospital death. Our data can be useful in preoperative risk stratification.

Project description:Background:Opioid use is common in end-stage renal disease (ESRD) patients. However, safety of individual opioids and concomitant benzodiazepine use has not been studied. Objective:To study the epidemiology of opioid and concomitant benzodiazepine use in ESRD population. To study the clinical safety profile of individual opioids in patients on hemodialysis. Design:Retrospective analysis of the U.S. Renal Data System. A comprehensive review of the current literature was performed to update currently used opioid safety classification. Participants:ESRD patients ≥18 years on hemodialysis who were enrolled in Medicare A and B and Part D between 2006 and 2012, excluding those with malignancy. Main Measures:Hospital admission with diagnosis of prescription opioid overdose within 30, 60, and 90 days of prescription; death due to opioid overdose. Results:Annually, the percentage of patients prescribed any opioid was 52.2%. Overall trend has been increasing except for a small dip in 2011, despite which the admissions due to opioid overdose have been rising. 30% of those who got a prescription for opioids also got a benzodiazepine prescription. 56.5% of these patients received both prescriptions within a week of each other. Benzodiazepine use increased the odds of being on opioids by 3.27 (CI 3.21-3.32) and increased the odds of hospitalization by 50%. Opioids considered safe such as fentanyl and methadone were associated with 3 and 6 folds higher odds of hospitalization within 30 days of prescription. Hydrocodone had the lowest odds ratio (1.9, CI 1.8-2.0). Conclusions:Concurrent benzodiazepine use is common and associated with higher risk of hospitalization due to opioid overdose. Possible opioid-associated hospital admission rate is 4-5 times bigger in ESRD population than general population. Current safety classification of opioids in these patients is misleading, and even drugs considered safe based on pharmacokinetic data are associated with moderate to very high risk of hospitalization. We propose a risk-stratified classification of opioids and suggest starting to use them in all ESRD patients.

Project description:Deceased-donor renal transplant (DDRT) is an expensive and potentially risky health intervention with the prospect of improved life and lower long-term costs compared with dialysis. Due to the increasing shortage of kidneys and the associated rise of transplantation costs, certain patient groups may not benefit from transplantation in a cost-effective manner compared with dialysis. The objective of this systematic review was to provide a comprehensive synthesis of evidence on the cost-effectiveness of DDRT relative to dialysis to treat adults with end-stage renal disease and patient-, donor-, and system-level factors that may modify the conclusion. A systematic search of articles was conducted on major databases including MEDLINE, Embase, Scopus, EconLit, and the Health Economic Evaluations Database. Eligible articles were restricted to those published in 2001 or thereafter. Two reviewers independently assessed the suitability of studies and excluded studies that focused on recipients with age <18 years old and those of a living-donor or multiorgan transplant. We show that while DDRT is generally a cost-effective treatment relative to dialysis at conventional willingness-to-pay thresholds, a range of drivers including older patient age, comorbidity, and long wait times significantly reduce the benefit of DDRT while escalating healthcare costs. These findings suggest that the performance of DDRT on older patients with comorbidities should be carefully evaluated to avoid adverse results as evidence suggests that it is not cost-effective. Delayed transplantation may reduce the economic benefits of transplant which necessitates targeted policies that aim to shorten wait times. More recent findings have demonstrated that transplantation using high-risk donors may be a cost-effective and promising alternative to dialysis in the face of a lack of organ availability and fiscal constraints. This review highlights key concepts of health economic evaluations and the relevance of cost-effectiveness to inform care and decision-making in renal programs.

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Short-term safety and effectiveness of sugammadex for surgical patients with end-stage renal disease: a two-centre retrospective study.

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Short-term safety and effectiveness of sugammadex for surgical patients with end-stage renal disease: a two-centre retrospective study.

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