Anti-Factor Xa Level Monitoring for Enoxaparin Prophylaxis and Treatment in High-Risk Patient Groups.

Description Monitoring anti-factor Xa levels is a controversial topic in the inpatient setting due to resource utilization and unclear conditional guideline recommendations regarding this practice. Enoxaparin dosing in certain high-risk patient populations such as those with low body weight, obesity, renal insufficiency, and pregnancy has not been determined. The objective of this review was to assess the safety and efficacy of enoxaparin monitoring via anti-factor Xa levels in high-risk patient populations. The PubMed database was searched for articles related to low-molecular-weight heparin monitoring. Randomized controlled trials and meta-analyses that evaluated the safety and efficacy of enoxaparin prophylaxis and treatment in patients with extremes of weight, renal insufficiency, and pregnancy were selected. Fourteen studies representing four high-risk population patient groups were included. Patients with extremes of weight or who were pregnant were found to have subtherapeutic anti-factor Xa levels due to the weight-based dosing of enoxaparin. Those with renal insufficiency were found to be accumulating enoxaparin, indicating the need for a lower dose. Studies have shown that monitoring may be required in specific high-risk patient groups. Dose adjustments based on anti-factor Xa levels can prevent adverse events associated with enoxaparin. Further research involving larger patient populations would be necessary to determine the clinical efficacy of enoxaparin monitoring with anti-factor Xa levels.

Evaluation of Erythropoietin Stimulating Agents (ESA) and Their Effect on Blood Optimization for Cardiac Surgery.

BACKGROUND: Cardiovascular surgeries increase the risk of receiving blood transfusions. Erythropoietin stimulating agents (ESAs) have been used to decrease the transfusion rate. The objective of this study was to evaluate the administration of blood products post-cardiothoracic surgery after receiving ESAs. METHODS: This is a single-center, retrospective cohort study. RESULTS: Between May 2017 to May 2018, 52 adult patients underwent cardiac surgery and received ESAs pre-operatively and/or post-operatively. A total of 35 patients were included in the study and 21 (60%) patients did not require a blood transfusion while 14 (40%) patients required a blood transfusion (p = 0.597). The change in hemoglobin (Hgb = 0.773 g/dL, 1.7 g/dL; p = 0.002) and hematocrit (Hct = 2.31%, 4.3%; p = 0.04) was significantly different in patients who received ESAs alone versus ESAs with blood transfusion. Adverse drug reactions showed no significant difference between groups. CONCLUSIONS: In patients undergoing cardiac surgery, ESAs did not significantly reduce the need for blood transfusion. Future and larger studies are necessary to evaluate the effect of ESAs on blood transfusion.

Cosmetovigilance: A review of the current literature.

The term "pharmacovigilance" defines the activities related to the collection, detection, assessment, monitoring, and prevention of adverse reactions occurring with medications. Recently, the spectrum of "-vigilance" has broadened to include safety of herbal products and cosmetic products as well. "Cosmetovigilance" was introduced as a new term used for defining surveillance carried out by industry to address the safety of cosmetic products. It was first used in literature by Vigan (1997) to refer to the monitoring of cosmetic product safety. Today, it is recognized globally as a concept of public health. For this systematic review, a PubMed search was conducted in July 2018 for the term "cosmetovigilance."

Continuous Lidocaine Infusion as Adjunctive Analgesia in Intensive Care Unit Patients.

Despite a paucity of data, the role of intravenous lidocaine (IVLI) as adjunctive analgesia in the intensive care unit (ICU) seems promising due to a low potential to contribute to respiratory depression. A retrospective chart review was conducted to evaluate the safety and effectiveness of IVLI for the treatment of pain in ICU patients with varying degrees of organ dysfunction from March 2014 to March 2016. The primary outcomes included the time to a ≥20% reduction in pain scores after the initiation of IVLI and the difference in opioid requirements as well as pain scores prior to and during IVLI therapy. Other variables included the presence of IVLI-related adverse events and the dosage and duration of IVLI. A total of 21 ICU patients were included from 2 different hospitals. The mean time to a ≥20% reduction in pain scores from the start of IVLI was 3.3 hours (SD = 2.2). The median morphine dose equivalents required during 6, 12, and 24 hours pre-IVLI were significantly higher compared to the same time periods after IVLI (18.3 vs 10 mg, P = .002; 41.8 vs 18.3 mg, P = .002; 93.5 vs 30.5 mg, P = .037). Neurological adverse effects of lidocaine were noted in 3 patients, but the effects were reversed on IVLI discontinuation. This report suggests that IVLI as an adjunctive agent in the treatment of acute pain may be a potential option in ICU patients who are refractory to opioids or those in whom opioid-induced respiratory depression is a concern.

Chemoprophylaxis Use and Risk of Venous Thromboembolism and Death in Adult Patients following Orthotopic Liver Transplantation.

BACKGROUND: Coagulation abnormalities in end-stage liver disease may preclude patients from receiving venous thromboembolism (VTE) prophylaxis immediately following orthotopic liver transplantation. METHODS: To identify risk factors for VTE and death following liver transplantation, a retrospective chart review was conducted in adult liver transplant recipients from January 1, 2001, to October 1, 2011. RESULTS: In 716 transplantations in 701 patients, the overall incidence of VTE was 2.1%. The incidence was 3.6% in patients who received chemoprophylaxis compared to 1.4% in those without chemoprophylaxis (P = .06). Most patients (69.5%) did not receive chemoprophylaxis postsurgery during their hospitalization. Multivariate logistic regression modeling revealed no association between the use of chemoprophylaxis (adjusted odds ratio [OR] 1.5 [0.45-4.7], P = .53) and VTE. A significant positive association was observed between the use of chemoprophylaxis (adjusted OR 3.2 [1.3-8.0], P = .01) and death. CONCLUSION: Use of chemoprophylaxis and increasing amounts of blood products following orthotopic liver transplant was associated with increased mortality. A significant positive association was observed between blood product administration and VTE, while chemoprophylaxis use was not significantly associated with VTE. Larger prospective studies are necessary to further examine the significance of this finding.

Challenges of Administering Pancrelipase in Pancreatitis Patients.

OBJECTIVE: This study evaluated nutrition status to determine the impact of a novel approach using elemental nutrition compared to pancrelipase administration in patients with pancreatitis. METHODS: This retrospective study included adult patients with pancreatitis who were nil per os (NPO) and received elemental nutrition from August 2008 to 2010 (n = 24) or pancrelipase enzyme supplementation (PES) plus nonelemental enteral nutrition from August 2011 to 2013 (n = 41) at a large academic medical center. The primary outcome is the percentage of diarrhea-free days. Secondary outcomes include time-to-goal enteral nutrition from the enteral nutrition initiation and pre-albumin and albumin changes pre- and postenteral nutrition. RESULTS: There were no statistically significant differences between the 2 groups in percentage of diarrhea-free days (46.80% ± 29.03% vs 53.45% ± 36.76%, p = 0.45). Additionally, there were no differences in secondary outcomes of time-to-goal enteral nutrition and pre-albumin and albumin changes pre- and postenteral nutrition. CONCLUSION: Utilizing elemental nutrition compared to PES plus nonelemental enteral nutrition in patients with pancreatitis was not associated with a significant reduction in percentage of diarrhea-free days, time-to-goal enteral nutrition, and nutrition status. A multicenter, prospective, randomized, controlled trial is warranted to further evaluate the efficacy of elemental nutrition in patients with pancreatitis.

Clinical experience with prophylactic fondaparinux in critically ill patients with moderate to severe renal impairment or renal failure requiring renal replacement therapy.

BACKGROUND: Fondaparinux has an increased bleeding risk in patients with a CrCl ≤ 50 mL/min and is contraindicated if CrCl < 30 mL/min. Data regarding dosing and anti-Xa monitoring are lacking in this population. OBJECTIVE: To describe dosing, monitoring, and safety outcomes of prophylactic fondaparinux in critically ill patients with moderate to severe renal impairment, including renal replacement therapy (RRT). METHODS: Retrospective analysis from October 2006 to November 2012 of patients ≥ 18 years old who received fondaparinux for ≥ 72 hours with ≥ 1 dose in an intensive care unit and a CrCl ≤ 50 mL/min or RRT during therapy. Participants were divided into 4 cohorts: moderate impairment (CrCl = 30-50 mL/min), severe impairment (CrCl < 30 mL/min), hemodialysis (HD), or continuous venovenous hemofiltration (CVVH). Outcomes included the incidence of clinically significant bleeding and thromboembolic events. Fondaparinux dose, dosing frequency, and anti-Xa level monitoring are described. Pharmacokinetic modeling was performed to assess drug accumulation. RESULTS: In all, 95 patients met inclusion criteria: 64 (67.4%) with moderate impairment, 10 (10.5%) with severe impairment, 5 (5.3%) with HD, and 16 (16.8%) with CVVH. The median defined daily doses in the moderate, severe, HD, and CVVH cohorts were 2.5, 2.5, 0.9, and 1.9 mg. Anti-Xa monitoring occurred in 19 (20%) patients, although few concentrations were peaks. Clinically significant bleeding occurred in 4 (4.2%) patients. A pharmacokinetic model demonstrated drug accumulation. CONCLUSIONS: Empirical dose adjustments may be prudent in critically ill patients with renal dysfunction; however, the optimal fondaparinux dosage in this population remains unknown. Peak anti-Xa concentrations may help guide therapy.