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Reduction of estimated fluid volumes following initiation of empagliflozin in patients with type 2 diabetes and cardiovascular disease: a secondary analysis of the placebo-controlled, randomized EMBLEM trial.
Tanaka, A, Shimabukuro, M, Teragawa, H, Okada, Y, Takamura, T, Taguchi, I, Toyoda, S, Tomiyama, H, Ueda, S, Higashi, Y, et al
Cardiovascular diabetology. 2021;(1):105
Abstract
BACKGROUNDS/AIM: Sodium glucose co-transporter 2 inhibitors promote osmotic/natriuretic diuresis and reduce excess fluid volume, and this improves cardiovascular outcomes, including hospitalization for heart failure. We sought to assess the effect of empagliflozin on estimated fluid volumes in patients with type 2 diabetes and cardiovascular disease (CVD). METHODS The study was a post-hoc analysis of the EMBLEM trial (UMIN000024502), an investigator-initiated, multi-center, placebo-controlled, double-blinded, randomized-controlled trial designed primarily to evaluate the effect of 24 weeks of empagliflozin treatment on vascular endothelial function in patients with type 2 diabetes and established CVD. The analysis compared serial changes between empagliflozin (10 mg once daily, n = 52) and placebo (n = 53) in estimated plasma volume (ePV), calculated by the Straus formula and estimated the extracellular volume (eEV), determined by the body surface area, measured at baseline and 4, 12, and 24 weeks after initiation of treatment. Correlations were examined between the changes from baseline to week 24 in each estimated fluid volume parameter and several clinical variables of interest, including N-terminal pro-brain natriuretic peptide (NT-proBNP) concentration. RESULTS In an analysis using mixed-effects models for repeated measures, relative to placebo empagliflozin reduced ePV by - 2.23% (95% CI - 5.72 to 1.25) at week 4, - 8.07% (- 12.76 to - 3.37) at week 12, and - 5.60% (- 9.87 to - 1.32) at week 24; eEV by - 70.3 mL (95% CI - 136.8 to - 3.8) at week 4, - 135.9 mL (- 209.6 to - 62.3) at week 12, and - 144.4 mL (- 226.3 to - 62.4) at week 24. The effect of empagliflozin on these parameters was mostly consistent across various patient clinical characteristics. The change in log-transformed NT-proBNP was positively correlated with change in ePV (r = 0.351, p = 0.015), but not with change in eEV. CONCLUSIONS Our data demonstrated that initiation of empagliflozin treatment substantially reduced estimated fluid volume parameters in patients with type 2 diabetes and CVD, and that this effect was maintained for 24 weeks. Given the early beneficial effect of empagliflozin on cardiovascular outcomes seen in similar patient populations, our findings provide an important insight into the key mechanisms underlying the clinical benefit of the drug. Trial registration University Medical Information Network Clinical Trial Registry, number 000024502.
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48-Hour Fluid Balance Does Not Predict a Successful Spontaneous Breathing Trial.
Antonio, AC, Teixeira, C, Castro, PS, Savi, A, Oliveira, RP, Gazzana, MB, Knorst, M
Respiratory care. 2015;(8):1091-6
Abstract
BACKGROUND Both premature and delayed liberation from mechanical ventilation are associated with increased morbidity and mortality, and fluid balance could negatively influence extubation outcomes. We sought to determine the impact of fluid balance in the 48 h before a spontaneous breathing trial (SBT) on weaning outcomes in a mixed ICU population. METHODS This was a prospective observational study in 2 adult medical-surgical ICUs. All enrolled subjects met eligibility criteria for weaning from mechanical ventilation. SBT failure was defined as inability to tolerate a T-piece trial for 30-120 min. Data on demographics, physiology, fluid balance in the 48 h preceding SBT (fluid input minus output over the 48-h period), lung ultrasound findings, and outcomes were collected. RESULTS Of a total of 250 SBTs, SBT failure eventuated in 51 (20.4%). Twenty-nine subjects (11.6%) had COPD, and 40 subjects (16%) were intubated due to respiratory sepsis. One-hundred eighty-nine subjects (75.6%) were extubated on the first attempt. Compared with subjects with SBT success, SBT failure subjects were younger (median of 66 vs. 75 y, P = .001) and had a higher duration of mechanical ventilation (median of 7 vs. 4 d, P < .001) and a higher prevalence of COPD (19.6 vs. 9.5%, P = .04). There were no statistically significant differences in 48-h fluid balance before SBT between groups (SBT failure, 1,201.65 ± 2,801.68 mL; SBT success, 1,324.39 ± 2,915.95 mL). However, in the COPD subgroup, we found a significant association between positive fluid balance in the 48 h before SBT and SBT failure (odds ratio of 1.77 [1.24-2.53], P = .04). CONCLUSIONS Fluid balance should not delay SBT indication because it does not predict greater probability of SBT failure in the medical-surgical critically ill population. Notwithstanding, avoiding positive fluid balance in patients with COPD might improve weaning outcomes. (ClinicalTrials.gov registration NCT02022839.).
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Fluid balance and urine volume are independent predictors of mortality in acute kidney injury.
Teixeira, C, Garzotto, F, Piccinni, P, Brienza, N, Iannuzzi, M, Gramaticopolo, S, Forfori, F, Pelaia, P, Rocco, M, Ronco, C, et al
Critical care (London, England). 2013;(1):R14
Abstract
INTRODUCTION In ICUs, both fluid overload and oliguria are common complications associated with increased mortality among critically ill patients, particularly in acute kidney injury (AKI). Although fluid overload is an expected complication of oliguria, it remains unclear whether their effects on mortality are independent of each other. The aim of this study is to evaluate the impact of both fluid balance and urine volume on outcomes and determine whether they behave as independent predictors of mortality in adult ICU patients with AKI. METHODS We performed a secondary analysis of data from a multicenter, prospective cohort study in 10 Italian ICUs. AKI was defined by renal sequential organ failure assessment (SOFA) score (creatinine >3.5 mg/dL or urine output (UO) <500 mL/d). Oliguria was defined as a UO <500 mL/d. Mean fluid balance (MFB) and mean urine volume (MUV) were calculated as the arithmetic mean of all daily values. Use of diuretics was noted daily. To assess the impact of MFB and MUV on mortality of AKI patients, multivariate analysis was performed by Cox regression. RESULTS Of the 601 included patients, 132 had AKI during their ICU stay and the mortality in this group was 50%. Non-surviving AKI patients had higher MFB (1.31 ± 1.24 versus 0.17 ± 0.72 L/day; P <0.001) and lower MUV (1.28 ± 0.90 versus 2.35 ± 0.98 L/day; P <0.001) as compared to survivors. In the multivariate analysis, MFB (adjusted hazard ratio (HR) 1.67 per L/day, 95%CI 1.33 to 2.09; <0.001) and MUV (adjusted HR 0.47 per L/day, 95%CI 0.33 to 0.67; <0.001) remained independent risk factors for 28-day mortality after adjustment for age, gender, diabetes, hypertension, diuretic use, non-renal SOFA and sepsis. Diuretic use was associated with better survival in this population (adjusted HR 0.25, 95%CI 0.12 to 0.52; <0.001). CONCLUSIONS In this multicenter ICU study, a higher fluid balance and a lower urine volume were both important factors associated with 28-day mortality of AKI patients.
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Vascular pedicle width in acute lung injury: correlation with intravascular pressures and ability to discriminate fluid status.
Rice, TW, Ware, LB, Haponik, EF, Chiles, C, Wheeler, AP, Bernard, GR, Steingrub, JS, Hite, RD, Matthay, MA, Wright, P, et al
Critical care (London, England). 2011;(2):R86
Abstract
INTRODUCTION Conservative fluid management in patients with acute lung injury (ALI) increases time alive and free from mechanical ventilation. Vascular pedicle width (VPW) is a non-invasive measurement of intravascular volume status. The VPW was studied in ALI patients to determine the correlation between VPW and intravascular pressure measurements and whether VPW could predict fluid status. METHODS This retrospective cohort study involved 152 patients with ALI enrolled in the Fluid and Catheter Treatment Trial (FACTT) from five NHLBI ARDS (Acute Respiratory Distress Syndrome) Network sites. VPW and central venous pressure (CVP) or pulmonary artery occlusion pressure (PAOP) from the first four study days were correlated. The relationships between VPW, positive end-expiratory pressure (PEEP), cumulative fluid balance, and PAOP were also evaluated. Receiver operator characteristic (ROC) curves were used to determine the ability of VPW to detect PAOP < 8 mmHg and PAOP ≥ 18 mm Hg. RESULTS A total of 71 and 152 patients provided 118 and 276 paired VPW/PAOP and VPW/CVP measurements, respectively. VPW correlated with PAOP (r = 0.41; P < 0.001) and less well with CVP (r = 0.21; P = 0.001). In linear regression, VPW correlated with PAOP 1.5-fold better than cumulative fluid balance and 2.5-fold better than PEEP. VPW discriminated achievement of PAOP < 8 mm Hg (AUC = 0.73; P = 0.04) with VPW ≤67 mm demonstrating 71% sensitivity (95% CI 30 to 95%) and 68% specificity (95% CI 59 to 75%). For discriminating a hydrostatic component of the edema (that is, PAOP ≥ 18 mm Hg), VPW ≥ 72 mm demonstrated 61.4% sensitivity (95% CI 47 to 74%) and 61% specificity (49 to 71%) (area under the curve (AUC) 0.69; P = 0.001). CONCLUSIONS VPW correlates with PAOP better than CVP in patients with ALI. Due to its only moderate sensitivity and specificity, the ability of VPW to discriminate fluid status in patients with acute lung injury is limited and should only be considered when intravascular pressures are unavailable.