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VolumE maNagement Under body composition monitoring in critically ill patientS on CRRT: study protocol for a randomized controlled trial (VENUS trial).

ABSTRACT: BACKGROUND:Despite recent technical advances in the management of acute kidney injury (AKI), such as continuous renal replacement therapy (CRRT), intensive care unit mortality is still high, at approximately 40 to 50%. Although several factors have been reported to predict mortality in AKI patients, fluid overload (FO) during CRRT is a well-known predictor of patient survival. However, FO has been mostly quantified as an arithmetical calculation and determined on the basis of the physicians' perception. Even though such quantification and assessment provides an easy evaluation of a patient's fluid status and is a simple method, it is not applicable unless a detailed record of fluid monitoring is available. Furthermore, the method cannot differentiate excess water in individual water compartments but can only reflect excess total body water. Bioimpedance analysis (BIA) has been used to measure the nutritional component of body composition and is a promising tool for the measurement of volume status. However, there has been no prospective interventional study for fluid balance among CRRT-treated AKI patients using BIA. Therefore, we will investigate the usefulness of fluid management using the InBody S10 (InBody®, Seoul, Korea), a BIA tool, compared with that of generally used quantification methods. METHODS/DESIGN:This will be a multicenter, prospective, randomized controlled trial. A total of 244 patients undergoing CRRT treatment will be enrolled and randomly assigned to receive either to InBody S10-guided management or to fluid management based only on clinical information for 7?days. The primary outcome is to compare the rate of euvolemic status 7?days after the initiation of CRRT, with a secondary outcome being to compare the 28-, 60-, and 90-day mortality rates between the two groups. DISCUSSION:This will be the first clinical trial to investigate the effect of using BIA-guided fluid management to achieve euvolemia in CRRT-treated AKI patients. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT03330626 . Registered on 6 November 2017.

SUBMITTER: Oh HJ

PROVIDER: S-EPMC6292088 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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VolumE maNagement Under body composition monitoring in critically ill patientS on CRRT: study protocol for a randomized controlled trial (VENUS trial).

Oh Hyung Jung HJ An Jung Nam JN Oh Sohee S Rhee Harin H Lee Jung Pyo JP Kim Dong Ki DK Ryu Dong-Ryeol DR Kim Sejoong S

Trials 20181212 1

<h4>Background</h4>Despite recent technical advances in the management of acute kidney injury (AKI), such as continuous renal replacement therapy (CRRT), intensive care unit mortality is still high, at approximately 40 to 50%. Although several factors have been reported to predict mortality in AKI patients, fluid overload (FO) during CRRT is a well-known predictor of patient survival. However, FO has been mostly quantified as an arithmetical calculation and determined on the basis of the physici ...[more]

PMID: 30541593

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Project description:Background and objectivesInfection is the most common cause of death in severe AKI, but many patients receiving continuous RRT do not reach target antibiotic concentrations in plasma. Extended infusion of β-lactams is associated with improved target attainment in critically ill patients; thus, we hypothesized that extended infusion piperacillin-tazobactam would improve piperacillin target attainment compared with short infusion in patients receiving continuous RRT.Design, setting, participants, & measurementsWe conducted an institutional review board-approved observational cohort study of piperacillin-tazobactam pharmacokinetics and pharmacodynamics in critically ill patients receiving continuous venovenous hemodialysis and hemodiafiltration at three tertiary care hospitals between 2007 and 2015. Antibiotic concentrations in blood and/or dialysate samples were measured by liquid chromatography, and one- and two-compartment pharmacokinetic models were fitted to the data using nonlinear mixed effects regression. Target attainment for piperacillin was defined as achieving four times the minimum inhibitory concentration of 16 μg/ml for >50% of the dosing cycle. The probabilities of target attainment for a range of doses, frequencies, and infusion durations were estimated using a Monte Carlo simulation method. Target attainment was also examined as a function of patient weight and continuous RRT effluent rate.ResultsSixty-eight participants had data for analysis. Regardless of infusion duration, 6 g/d piperacillin was associated with ≤45% target attainment, whereas 12 g/d was associated with ≥95% target attainment. For 8 and 9 g/d, target attainment ranged between 68% and 85%. The probability of target attainment was lower at higher effluent rates and patient weights. For all doses, frequencies, patient weights, and continuous RRT effluent rates, extended infusion was associated with higher probability of target attainment compared with short infusion.ConclusionsExtended infusions of piperacillin-tazobactam are associated with greater probability of target attainment in patients receiving continuous RRT.

Project description:Parameters of patients' body composition have been suggested as prognostic markers in several clinical conditions including cancer and liver transplantation, but only limited data on its value in critical illness exist to date. In this study, we aimed at evaluating a potential prognostic value of the skeletal muscle mass and skeletal muscle myosteatosis of critically ill patients at admission to the ICU.DesignExploratory observational cohort study.SettingAn urban, academic medical institution.PatientsOne-hundred fifty-five patients treated for critical illness on a medical ICU.InterventionsNone.Measurements and main resultsWe used routine CT scans to assess the patients' individual body composition. The skeletal muscle index as a surrogate for sarcopenia was defined as the total skeletal muscle area at the level of the third lumbar vertebra on axial CT scan, normalized for the patient's height. Myosteatosis was evaluated by assessing the mean skeletal muscle attenuation measured in Hounsfield unit at the same sectional plane. The skeletal muscle index and mean skeletal muscle attenuation at admission to the ICU were significantly higher in patients with long-term survival (180-day or 1-year mortality), while both parameters were comparable between short-term survivors and nonsurvivors (ICU mortality or 30-d mortality). Patients with a skeletal muscle index or mean skeletal muscle attenuation below our established ideal cutoff values (74.95 mm2/cm and 29 Hounsfield unit) showed a significantly reduced overall survival. These findings were confirmed in univariate and multivariate Cox regression analyses. Furthermore, myosteatosis significantly correlated with the time of mechanical ventilation, the duration of hospital stay, and the presence of sepsis.ConclusionsOur data suggest that sarcopenia and myosteatosis represent important prognostic factors in critically ill patients that can be easily obtained from routine CT scans. Both parameters at admission to the ICU yield important information on the patients' long-term outcome and might be used for early clinical decision-making in these patients.

Project description:IntroductionPhlebitis is an important complication in patients with peripheral intravascular catheters (PIVCs). Although an association between body mass index (BMI) and phlebitis has been suggested, the risk of phlebitis according to BMI has not been well elucidated. Therefore, in this study, we analyzed the risk of phlebitis according to BMI in patients in the intensive care unit (ICU).Materials and methodsThis study undertook a secondary analysis of the data from a prospective multicenter observational study assessing the epidemiology of phlebitis at 23 ICUs in Japan. Patients admitted into the ICU aged ≥18 years with a new PIVC inserted after ICU admission were consecutively enrolled and stratified into the following groups based on BMI: Underweight (BMI < 18.5 kg/m2), normal weight (18.5 ≤ BMI < 25.0 kg/m2), and overweight/obese (BMI ≥ 25.0 kg/m2). The primary outcome was phlebitis. The risk factors for phlebitis in each BMI-based group were investigated using a marginal Cox regression model. In addition, hazard ratios and 95% confidence intervals were calculated.ResultsA total of 1,357 patients and 3,425 PIVCs were included in the analysis. The mean BMI for all included patients was 22.8 (standard deviation 4.3) kg/m2. Among the eligible PIVCs, 455; 2,041; and 929 were categorized as underweight, normal weight, and overweight/obese, respectively. In the underweight group, catheter size ≥ 18 G and amiodarone administration were independently associated with the incidence of phlebitis. Drug administration standardization was associated with the reduction of phlebitis. In the normal weight group, elective surgery as a reason for ICU admission, and nicardipine, noradrenaline, and levetiracetam administration were independently associated with the incidence of phlebitis. Heparin administration was associated with the reduction of phlebitis. In the overweight/obese group, the Charlson comorbidity index, catheter size ≥ 18 G, and levetiracetam administration were independently associated with the incidence of phlebitis. Catheters made from PEU-Vialon (polyetherurethane without leachable additives) and tetrafluoroethylene were associated with the reduction of phlebitis.ConclusionWe investigated the risk factors for peripheral phlebitis according to BMI in ICU and observed different risk factors in groups stratified by BMI. For example, in underweight or overweight patients, large size PIVCs could be avoided. Focusing on the various risk factors for phlebitis according to patients' BMIs may aid the prevention of phlebitis.

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VolumE maNagement Under body composition monitoring in critically ill patientS on CRRT: study protocol for a randomized controlled trial (VENUS trial).

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VolumE maNagement Under body composition monitoring in critically ill patientS on CRRT: study protocol for a randomized controlled trial (VENUS trial).

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