Clinical experience of prophylactic enoxaparin dosage adjustment guided by AntiXa factor levels in critical care patients with COVID-19-induced pneumonia: observational study.
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ABSTRACT:
SUBMITTER: Bermudez-Ruiz MDC
PROVIDER: S-EPMC10201310 | biostudies-literature | 2023 May
REPOSITORIES: biostudies-literature
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Clinical experience of prophylactic enoxaparin dosage adjustment guided by AntiXa factor levels in critical care patients with COVID-19-induced pneumonia: observational study.
Bermúdez-Ruiz María Del Carmen MDC Vilar Sánchez Irene I Aparicio Pérez Clara C Carmona Flores Rosario R Rodríguez-Gómez Jorge J de la Fuente-Martos Carmen C
Medicina intensiva 20230522 8
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| S-EPMC10165054 | biostudies-literature
Project description:ObjectivesThe purposes of this study are to perform a large-scale evaluation of the standardized dosage adjustment nomogram recommended by the American College of Chest Physicians (CHEST) for the management of enoxaparin in hospitalized pediatric patients and to determine the necessity of routine and repeated anti-factor Xa (anti-Xa) levels.MethodsA retrospective cohort study was designed, and charts were reviewed in a single tertiary care institution for all patients who received enoxaparin between October 1, 2010, through September 30, 2016. Patients were included if they were receiving treatment doses of enoxaparin according to the pediatric CHEST guidelines, had a subtherapeutic or supratherapeutic anti-Xa level drawn at 3.5 to 6 hours after a dose, had a dose changed in an attempt to attain a therapeutic anti-Xa level, and had a second anti-Xa level drawn 3.5 to 6 hours after the dose change. Descriptive statistical methods were used to characterize the ability of dose adjustment via a nomogram to attain an anti-Xa of 0.5 to 1 unit/mL.ResultsA total of 467 patients were identified who received the appropriate initial dose and dosage adjustment and whose levels were drawn according to the CHEST guidelines. In patients who had an initial anti-Xa level of <0.35 units/mL and received the nomogram recommended dose increase of 25% ± 5%, 28 out of 96 patients (29.2%) reached therapeutic levels. Of 197 patients who had an initial anti-Xa level between 0.35 and 0.49 units/mL and who received the nomogram recommended dose increase of 10% ± 5%, 116 (58.9%) reached therapeutic levels. Of 50 patients with an initial anti-Xa level between 1.1 and 1.5 units/mL and who received the nomogram dose decrease of 20% ± 5%, 31 (62%) reached therapeutic levels.ConclusionsThe current dosage adjustment nomogram recommended by the CHEST guidelines does not reliably lead to therapeutic anti-Xa levels when used to adjust enoxaparin doses in pediatric patients.
| S-EPMC6478360 | biostudies-literature
Project description:IntroductionEnoxaparin prophylaxis prevents venous thromboembolism in surgical patients. Real time anti-Factor Xa monitoring for surgical patients on enoxaparin prophylaxis is increasingly common.Presentation of casesWe report on three cancer patients with therapeutic or supratherapeutic anti-Factor Xa levels while on prophylactic doses of enoxaparin after surgical procedures. In all cases, elevated anti-Factor Xa levels were the result of blood specimens being removed from a heparinized chemoport.DiscussionThis case series highlights the importance of peripheral venipuncture or appropriate blood wasting from central access sites for anti-Factor Xa levels.ConclusionInappropriately drawn anti-Factor Xa levels may contribute to prophylaxis interruption or unnecessary workup for renal or liver failure.
| S-EPMC5048076 | biostudies-literature
Project description:BackgroundCritically ill patients frequently require continuous renal replacement therapy (CRRT). During CRRT, particles up to 10 kDa in size, such as enoxaparin, may be removed. The aim of this study was to determine if patients receiving prophylactic doses of enoxaparin and treated with continuous veno-venous hemodiafiltration (CVVHDF) reach prophylactic values of anti-Xa factor activity.MethodsIn this observational trial, we compared two groups: 20 patients treated with CVVHDF and 20 patients not treated with CVVHDF. All of them received prophylactic doses of 40 mg of enoxaparin subcutaneously. Anti-Xa factor activity was determined on the third day of receiving a prophylactic dose of enoxaparin. The first blood sample was taken just before the administration of enoxaparin, and other samples were taken 3 h, 6 h, and 9 h after the administration of a prophylactic dose of enoxaparin.ResultsAt 3 and 6 h after administration of enoxaparin in both groups, we observed a significant increase in anti-Xa factor activity from baseline, with the peak after 3 h of administration. There were no significant differences in the numbers of patients who had anti-Xa factor activity within the prophylactic range between CVVHDF and control groups.ConclusionCVVHDF has only a mild effect on the enoxaparin prophylactic effect measured by anti-Xa factor activity. Thus, it seems there is no need to increase the dose of enoxaparin for patients requiring CVVHDF.
| S-EPMC10457944 | biostudies-literature
Project description:Purpose: The purpose of this study was 1) to predict the requisite vancomycin daily dose (D van ) used in the target patients suffering from both bacterial infection and hematological malignancies and 2) to construct a vancomycin-dose-graphical tool to assist clinicians to develop vancomycin dosing regimens and further 3) to establish a programming process for vancomycin dynamic dosage adjustment to help clinicians to adjust vancomycin dosing regimens according to physiological and pathogenic factors of the target patients. Methods: The D van model associated with microbial susceptibility, vancomycin pharmacokinetics, and dosing parameters was established, and the D van was estimated based on the established D van model and using Monte Carlo simulations. D van achieving 90% of probability of target attainment (PTA) for bacterial isolate or cumulative fractions of response (CFR) for the bacterial population at a ratio of daily area under the curve (AUC24) to the minimum inhibitory concentration (MIC) [i.e., AUC24/MIC] of 400-600 was considered sufficient to treat infection occurring in the target patients. On the basis of the predicted D van , the physiological states of patients, and the pathogenic variables of infection, a vancomycin-dose-graphical tool for the target patients and a programming process for vancomycin dynamic dosage adjustment were constructed. Results: This study predicted the requisite D van used in patients suffering from both bacterial infection and hematological malignancies and constructed a vancomycin-dose-graphical tool for the target patients, at different physiological states and pathogenic variables, to formulate vancomycin dosing regimens. Also, this study established and expounded the formulation process of vancomycin dosage dynamic adjustment according to fluctuant renal function of the target patients. Conclusion: With the tools, the required D van or vancomycin dosing regimens for the target patients, at different physiological states and pathogenic variables, can be readily known, whether or not vancomycin dynamic dosage adjustment is required.
| S-EPMC9207402 | biostudies-literature
Project description:IntroductionSevere obesity predisposes youth to a higher risk of venous thromboembolism (VTE). This study evaluates a BMI-stratified prophylactic dosing regimen of enoxaparin in adolescents with severe obesity undergoing surgery.MethodsAdolescents aged 12-20 years received prophylactic enoxaparin at 40 mg SC (for a BMI < 50 kg/m2) and 60 mg SC (for a BMI ≥ 50 kg/m2) every 12 h until discharge. Blood samples were drawn at pre-dose, 1, 2, 4, 6, and 12 h. Plasma Anti-Factor Xa (Anti-FXa) activity was used as a surrogate marker for enoxaparin pharmacokinetics.ResultsTen female and two male obese adolescents (age range 14-19 years) had a mean BMI of 49.9 kg/m2 (38.4-58 kg/m2). Four patients had a BMI of less than 50 kg/m2 and received 40 mg enoxaparin, resulting in a mean dosage of 0.352 ± 0.070 mg/kg body weight. Eight patients were dosed with 60 mg enoxaparin every 12 h, resulting in a mean dosage of 0.395 ± 0.028 mg/kg. Peak plasma anti-FXa activity (Cmax) ranged from 0.14 to 0.30 IU/mL, median Cmax was 0.205 IU/mL. Median Tmax was 5.67 h (range 3.78-7.52 h). Median AUCi was 1.00 h IU/mL (range 0.42-1.67 h IU/mL). Ten out of 12 patients (83%) reached the primary endpoint with anti-FXa activity in the range for VTE prevention (0.1-0.3 IU/mL).ConclusionsOur dosing scheme of 40 mg vs. 60 mg enoxaparin stratified according to BMI proved to be effective in reaching prophylactic anti-FXa activity in 83% of adolescent patients.
| S-EPMC7375856 | biostudies-literature
Project description:Cystatin C (CysC) may estimate renal function more accurately than serum creatinine (SCr). The clinical impact of renal dose adjustment of cefepime according to CysC rather than SCr has remained uncertain. We investigated the efficacy and safety of CysC-guided cefepime dosing compared with SCr-guided dosing in hospitalized patients with pneumonia. All adults hospitalized with pneumonia between July 2016 and December 2018 who used cefepime for at least 3 days were enrolled. Mortality, acute kidney injury (AKI), cefepime-induced encephalopathy (CIE), and Clostridium difficile infection were compared between the CysC-guided and SCr-guided groups. One hundred and ninety patients were divided into two groups: 129 and 61 received cefepime based on CysC and SCr, respectively. In-hospital mortality did not significantly differ between the groups (12% versus 31%; hazard ratio (HR) 0.74; 95% confidence interval (CI), 0.31-1.77; p = 0.50). CysC-guided cefepime dosing decreased the risk of AKI (13% versus 61%; HR 0.18; 95% CI, 0.07-0.44; p < 0.001) and CIE (2% versus 11%; HR 0.11; 95% CI, 0.03-0.47; p = 0.003) compared with SCr-guided dosing. There was no significant difference in the risk of Clostridium difficile infection. CysC-guided dosing of cefepime was associated with decreased risk of the cefepime-associated morbidities including AKI and CIE without increasing mortality among the hospitalized patients with pneumonia.
| S-EPMC7564664 | biostudies-literature
Project description:BackgroundThromboprophylaxis dosing strategies using enoxaparin in elderly patients with renal disease are limited, while dose adjustments or monitoring of anti-Xa levels are recommended. We sought to evaluate the efficacy and safety of enoxaparin 20 mg versus 30 mg subcutaneously daily by comparing anti-Xa levels, thrombosis and bleeding.MethodsWe conducted a prospective, single-blinded, single-center randomized clinical trial including non-surgical patients, 70 years of age or older, with renal disease requiring thromboprophylaxis. Patients were randomized to receive either 20 mg or 30 mg of enoxaparin. The primary endpoint was peak anti-Xa levels on day 3. Secondary endpoints included trough anti-Xa levels on day 3, achievement of within range prophylactic target peak anti-Xa levels and the occurrence of hemorrhage, thrombosis, thrombocytopenia or hyperkalemia during hospitalization.ResultsThirty-two patients were recruited and sixteen patients were randomized to each arm. Mean peak anti-Xa level was significantly higher in 30 mg arm (n = 13) compared to the 20 mg arm (n = 11) 0.26 ± 0.11, 95%CI (0.18-0.34), versus 0.14 ± 0.09, 95CI (0.08-0.19) UI/ml, respectively; p = 0.004. Mean trough anti-Xa level was higher in 30 mg arm (n = 10) compared to the 20 mg arm (n = 16), 0.06 ± 0.03, 95CI (0.04-0.08) versus 0.03 ± 0.03, 95CI (0.01-0.05) UI/ml, respectively; p = 0.044. Bleeding events reported in the 30 mg arm were one retroperitoneal bleed requiring multiple transfusions, and in the 20 mg arm one hematuria. No thrombotic events were reported.ConclusionPeak anti-Xa levels provided by enoxaparin 20 mg were lower than the desired range for thromboprophylaxis in comparison to enoxaparin 30 mg.Trial registrationThe trial was retrospectively registered on ClinicalTrials.gov identifier: NCT03158792 . Registered: May 18, 2017.
| S-EPMC6505244 | biostudies-literature
Project description:BackgroundThe objectives of the present prospective observational study conducted in patients receiving conventional dosage of linezolid was to define the pharmacodynamic range of linezolid exposure, to assess the inter-individual variability in linezolid concentrations, and to define if therapeutic drug monitoring (TDM) of linezolid may be necessary for Chinese population.MethodsPatients included in this study underwent linezolid TDM trough concentration (C min) during treatment with a standard regimen in the period between January 2019 and October 2019. Linezolid C min was analyzed with high-performance liquid chromatography (HPLC) method. Logistic regression was used to define the desired range of linezolid C min. Linear regression and univariate logistic regression analysis were carried out to investigate variables associated with inappropriate linezolid plasma exposure.ResultsA total of 84 patients who had 153 linezolid C min assessed were included in the study. Median linezolid C min was 3.43 mg/L (IQR 1.59-5.93). The estimated probability of thrombocytopenia was 50% in the presence of C min of 7.85 mg/L. Approximately 57.52% (88/153) of the samples fell within the desired range of linezolid C min (2-8 mg/L) while 31.37% (48/153) experienced underexposure, and overexposure occurred in 11.11% (17/153) of the patients. No significant linear relationships between either body weight or estimated creatinine clearance (CrCL) and C min were detected. Estimated CrCL ≥100 mL/min was significantly associated with linezolid underexposure (OR 4.121; 95% CI, 1.945-8.731; P<0.001). Estimated CrCL ≤40 mL/min was significantly associated with linezolid overexposure (OR 3.761; 95% CI, 1.324-10.681; P=0.013).ConclusionsOur results suggest that the pharmacodynamic range of linezolid C min can be defined as 2-8 mg/L for the Chinese population. Renal function partially accounts for the inter-interindividual variability of exposure. The application of TDM might be especially valuable in optimizing linezolid exposure in the majority of patients to avoid therapeutic failure and/or dose-dependent adverse reactions.
| S-EPMC7210126 | biostudies-literature
Project description:Turkeys' body weight (BW) increases 10-fold within only 2.5 months, leading to a change in the pharmacokinetics (PK) of drugs according to allometric principles. Thus, the same dosage may lead to age-dependent variability in efficacy, in particular, to treatment failure and/or selection for resistance. The study aimed to investigate whether a non-linear dosage based on a published allometric model for tylosin clearance, may optimize the internal exposure in growing turkeys. The single dose PK study was performed on turkeys aged 6, 9.5, 13 and 17 weeks (BW from 1.75 kg to 15.75 kg). Tylosin was administered intravenously (i.v.) or orally (p.o.) according to following protocols: Dose = 31.6 × BW0.58 or Dose = 158 × BW0.58, respectively. Plasma tylosin was measured using high-performance liquid chromatography and non-compartmental PK analysis was performed. The area under the curve (AUClast) after i.v. administration was 8.90 ± 1.01; 7.51 ± 1.11; 6.54 ± 1.20 and 8.01 ± 1.75 mg × h/L in 6-; 9.5-; 13- and 17-week-old turkeys, respectively. After p.o. administration AUClast was 4.80 ± 2.92; 4.60 ± 2.45; 3.00 ± 1.49 and 3.24 ± 2.00 mg × h/L in respective age groups indicating high variability. For i.v. administration, the non-linear dosage allowed to minimize the age-dependent variability in AUC. However, due to low oral bioavailability (8-12%) and resulting interindividual variability, the proposed approach may not improve tylosin efficacy in turkeys under farm conditions.
| S-EPMC8467158 | biostudies-literature