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Thiamine dose response in human milk with supplementation among lactating women in Cambodia: study protocol for a double-blind, four-parallel arm randomised controlled trial.
Whitfield, KC, Kroeun, H, Green, T, Wieringa, FT, Borath, M, Sophonneary, P, Measelle, JR, Baldwin, D, Yelland, LN, Leemaqz, S, et al
BMJ open. 2019;(7):e029255
Abstract
INTRODUCTION Thiamine (vitamin B1) deficiency remains a concern in Cambodia where women with low thiamine intake produce thiamine-poor milk, putting their breastfed infants at risk of impaired cognitive development and potentially fatal infantile beriberi. Thiamine fortification of salt is a potentially low-cost, passive means of combating thiamine deficiency; however, both the dose of thiamine required to optimise milk thiamine concentrations as well as usual salt intake of lactating women are unknown. METHODS AND ANALYSIS In this community-based randomised controlled trial, 320 lactating women from Kampong Thom, Cambodia will be randomised to one of four groups to consume one capsule daily containing 0, 1.2, 2.4 or 10 mg thiamine as thiamine hydrochloride, between 2 and 24 weeks postnatal. The primary objective is to estimate the dose where additional maternal intake of thiamine no longer meaningfully increases infant thiamine diphosphate concentrations 24 weeks postnatally. At 2, 12 and 24 weeks, we will collect sociodemographic, nutrition and health information, a battery of cognitive assessments, maternal (2 and 24 weeks) and infant (24 weeks only) venous blood samples (biomarkers: ThDP and transketolase activity) and human milk samples (also at 4 weeks; biomarker: milk thiamine concentrations). All participants and their families will consume study-provided salt ad libitum throughout the trial, and we will measure salt disappearance each fortnight. Repeat weighed salt intakes and urinary sodium concentrations will be measured among a subset of 100 participants. Parameters of Emax dose-response curves will be estimated using non-linear least squares models with both 'intention to treat' and a secondary 'per-protocol' (capsule compliance ≥80%) analyses. ETHICS AND DISSEMINATION Ethical approval was obtained in Cambodia (National Ethics Committee for Health Research 112/250NECHR), Canada (Mount Saint Vincent University Research Ethics Board 2017-141) and the USA (University of Oregon Institutional Review Board 07052018.008). Results will be shared with participants' communities, as well as relevant government and scientific stakeholders via presentations, academic manuscripts and consultations. TRIAL REGISTRATION NUMBER NCT03616288.
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Clinical predictors of acute hyponatremia following LARIAT ligation of the left atrial appendage.
Holmes, BB, Patel, N, Lugo, R, Richardson, T, Metawee, M, Rinke, LL, Meisch, C, Shoemaker, MB, Ellis, CR
Journal of cardiovascular electrophysiology. 2019;(11):2501-2507
Abstract
INTRODUCTION Hyponatremia commonly follows percutaneous exclusion of the left atrial appendage (LAA) with the LARIAT suture delivery device. The aim of this study was to evaluate for clinical predictors hyponatremia following ligation of the appendage with the LARIAT device. METHODS AND RESULTS A retrospective analysis was conducted on 61 consecutive patients (average age 69.7 ± 9.8 years, 55.7% male) who underwent successful appendage ligation with the LARIAT device. Acute hyponatremia (AH) was defined as a drop in serum sodium (Na) by greater than or equal to 4 mmol/L within 48 hours of ligation while exaggerated acute hyponatremia (EAH) was defined as a drop greater than or equal to 10 mmol/L. Among all patients, there was a significant decrease in [Na] at 24 hours (3.26 ± 2.77 mmol/L) and 48 hours (4.98 ± 3.74 mmol/L). Thirty-two patients (52.4%) had AH while six patients (9.8%) experienced EAH. A body mass index (BMI) of less than 28.4 kg/m2 was associated with AH (P = .037) while a BMI < 25 kg/m2 was associated with EAH (P = .021). A linear regression analysis comparing the maximum sodium decrease to the indexed left atrial (LA) diameter found that for every 1 cm/m2 increase in indexed LA diameter, there was a 2.5 mEq/L decrease in serum sodium (P = .04). CONCLUSIONS Hyponatremia frequently occurs following LAA ligation with the LARIAT device. A low BMI < 25 kg/m2 is associated with a drop in serum sodium of greater than 10 mmol/L while increasing indexed LA diameter predicts any AH. AH is also associated with a significantly lower systolic blood pressure 48 to 72 hours post LAA exclusion with the LARIAT device.
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Impact of fractional excretion of sodium on a single morning void urine collection as an estimate of 24-hour urine sodium.
Nowson, CA, Lim, K, Campbell, NRC, O'Connell, SL, He, FJ, Daly, RM
Journal of clinical hypertension (Greenwich, Conn.). 2019;(12):1763-1770
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Abstract
The standard for assessing dietary sodium intake is to measure 24-hour urine sodium. On average, 93% of daily sodium intake is excreted over 24-hours. Expense and difficulties in obtaining complete 24-hour collections have led to the measurement of sodium concentration in spot and single-void urine samples, using predictive equations to estimate 24-hour urine sodium. Although multiple predictive equations have been developed, in addition to having an average bias, all the equations overestimate 24-hour sodium at lower levels of 24-hour sodium and underestimate 24-hour urine sodium at higher levels of 24-hour sodium. One of the least biased estimating equations is the INTERSALT equation, which incorporates a spot urine creatinine concentration. The authors hypothesized that differential fractional excretion of sodium (FeNa)(derived from a morning void collection) relative to creatinine would impact on the accuracy of the INTERSALT equation in estimating 24-hour urine sodium. In a prospective study of 139 adults aged 65 years and over, three sequential morning void and 24-hour urine samples were examined. There was a significant correlation between increasing FENa and the difference between estimated and measured 24-hours urine sodium (r = 0.358, P < .01). In the lowest quartile of FENa, the INTERSALT equation overestimated 24-hour urine sodium, but underestimated 24-hour urine sodium with greater magnitude in each of the subsequent quartiles of FENa. Differential excretion of sodium relative to creatinine, potentially impacted by renal blood flow and hydration, among other factors, affected the accuracy of the INTERSALT equation. Additional research may refine the INTERSALT and other predictive equations to increase their accuracy.
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Twenty-Four-Hour Urinary Sodium and Potassium Excretion in China: A Systematic Review and Meta-Analysis.
Tan, M, He, FJ, Wang, C, MacGregor, GA
Journal of the American Heart Association. 2019;(14):e012923
Abstract
Background In China, high sodium and low potassium intakes result in elevated blood pressure, a major cause of cardiovascular disease, yet the intake estimates lack accuracy and nutritional strategies remain limited. Methods and Results We aimed to determine sodium and potassium intake by systematically searching for and quantitatively summarizing all published 24-hour urinary sodium and potassium data (ie, the most accurate method). MEDLINE , EMBASE , Scopus, China National Knowledge Infrastructure, and Wanfang were searched up to February 2019. All studies reporting 24-hour urinary sodium or potassium in China were included; hospitalized patients were excluded. Data were pooled using random-effects meta-analysis and heterogeneity was explored with meta-regression. Sodium data were reported in 70 studies (n=26 767), 59 of which also reported potassium (n=24 738). Mean sodium and potassium excretions were 86.99 mmol/24 h (95% CI , 69.88-104.10) and 14.65 mmol/24 h (95% CI , 11.10-18.20) in children aged 3 to 6 years, 151.09 mmol/24 h (95% CI , 131.55-170.63) and 25.23 mmol/24 h (95% CI , 22.37-28.10) in children aged 6 to 16 years, and 189.07 mmol/24 h (95% CI , 182.14-195.99) and 36.35 mmol/24 h (95% CI , 35.11-37.59) in adults aged >16 years. Compared with southern China, sodium intake was higher in northern China ( P<0.0001) but is declining ( P=0.0066). Conclusions Average sodium intake in all age groups across China is approximately double the recommended maximum limits, and potassium intake is less than half that recommended. Despite a decline, sodium intake in northern China is still among the highest in the world, and the North-South divide persists. Urgent action is needed to simultaneously reduce sodium and increase potassium intake across China.
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Daily urinary sodium and potassium excretion in Chinese first-generation migrants in Italy.
Modesti, PA, Marzotti, I, Rapi, S, Rogolino, A, Cappuccio, FP, Zhao, D, Costanzo, G, Galanti, G, Boddi, M
International journal of cardiology. 2019;:175-180
Abstract
BACKGROUND China has one of the highest salt intake levels in the world, and Chinese people form one of the largest foreign-born communities now living in Europe. The present study was performed to assess 24-hour urinary sodium and potassium excretion in Chinese migrants in Italy and to explore possible associations with hypertension, hypertension awareness, and length of residence in Italy. METHODS A cross-sectional evaluation was conducted on 319 first-generation Chinese migrants (154 women and 165 men) aged 18-70 years. Subjects were asked to do a 24-hour urine collection and the relationships of urinary sodium and potassium and arterial blood pressure, hypertension (BP ≥ 140/90 mmHg or anti-hypertensive drug use), hypertension awareness, and years of residence in Italy were investigated with linear or logistic regression analysis. RESULTS Sodium excretion was 145.2 mmol/day (95%CI 138.0-152.3) in men, and 134.7 (95%CI 127.6-141.8) in women corresponding to a dietary salt intake of 9.4 g/day (95%CI 9.0-9.9) and 8.8 (95%CI 8.3-9.2) respectively. Potassium excretion was 35.1 mmol/day (95%CI 33.6-36.5), with no significant difference by gender. At multivariable adjusted linear regression analysis body mass index, low education level, and hypertension were positive predictors of sodium urinary excretion; gender (women), and body mass index were positive predictors of potassium excretion. Sodium and potassium excretion were unaffected by hypertension awareness or years of residence in Italy. CONCLUSIONS Sodium excretion in Chinese workers is higher than recommended and in line with high salt intake in Italy. Potassium consumption remains low.
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An observational study on intracutaneous sodium storage in intensive care patients and controls.
van IJzendoorn, M, van den Born, J, Hijmans, R, Bodde, R, Buter, H, Dam, W, Kingma, P, Maes, G, van der Veen, T, Zijlstra, W, et al
PloS one. 2019;(10):e0223100
Abstract
The development of ICU-acquired sodium disturbances is not fully understood. Alterations in non-osmotic skin sodium storage, hypothetically inflammation-driven, could play a role. To investigate this in critically ill patients we conducted a patient-control study with skin punch biopsies in patients with sepsis (n = 15), after coronary artery bypass grafting (CABG, n = 15) and undergoing total hip arthroplasty (THA-controls, n = 15) respectively, together representing a range in severity of systemic inflammation. Biopsies were taken within 24 hours (sepsis) and within 2 hours (CABG) after ICU-admission, and prior to arthroplasty. Biopsies were analysed for sodium content. In addition immunostainings and quantitative real time PCR were performed. The primary aim of this study was to detect possible differences in amounts of cutaneous sodium. The secondary aims were to quantify inflammation and lymphangiogenesis with concomitant markers. The highest amounts of both water and sodium were found in patients with sepsis, with slightly lower values after CABG and the lowest amounts in THA-controls. Correlation between water and sodium was 0.5 (p<0.01). In skin biopsies in all groups comparable amounts of macrophages, T-cells and lymph vessels were found. In all groups comparable expression of inflammation markers were found. However, higher mRNA transcript expression levels of markers of lymphangiogenesis were found in patients with sepsis and after CABG. The conjoint accumulation of water and sodium points towards oedema formation. However, the correlation coefficient of 0.5 leaves room for alternative explanations, including non-osmotic sodium storage. No signs of dermal inflammation were found, but upregulation of markers of lymphangiogenesis could indicate future lymphangiogenesis.
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Serial assessment of spot urine sodium predicts effectiveness of decongestion and outcome in patients with acute heart failure.
Biegus, J, Zymliński, R, Sokolski, M, Todd, J, Cotter, G, Metra, M, Jankowska, EA, Banasiak, W, Ponikowski, P
European journal of heart failure. 2019;(5):624-633
Abstract
AIMS: The clinical significance of the measurement of urine sodium concentration (UNa+ ) in response to loop diuretic administration in patients with acute heart failure (AHF) is still unsettled. We studied the association of serial measurements of spot UNa+ during the first 48 h of AHF treatment with the indices of decongestion, renal function, and prognosis. METHODS AND RESULTS We enrolled 111 AHF patients, all of whom received intravenous furosemide on admission. The mean spot UNa+ significantly increased in the 6 h sample (P < 0.05 vs. baseline) and returned to baseline values in the 24 and 48 h samples. Based on the increase or decrease/no change of UNa+ in the 6 and 48 h samples vs. baseline, patients were divided into two groups at each time point, respectively. Patients did not differ in baseline clinical and laboratory characteristics. Patients with a decrease/no change of UNa+ in the 6 and 48 h samples had a lower weight loss during hospitalization. Patients with a decrease/no change of UNa+ in the 48 h sample had a poorer diuretic response and a significant increase in the urinary levels of the tubular biomarkers: kidney injury molecule-1 and neutrophil gelatinase-associated lipocalin. Low UNa+ and decrease/no change in UNa+ in the 6 and 48 h samples were independent predictors of higher risk of all-cause mortality during 1-year follow-up (all P < 0.05). CONCLUSION In AHF, low spot UNa+ and lack to increase UNa+ in response to intravenous diuretics are associated with poor diuretic response, markers of tubular injury and high risk of 1-year mortality.
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Feasibility of Assessing Sodium-Associated Body Fluid Composition in End-Stage Renal Disease.
Clark-Cutaia, MN, Reisinger, N, Anache, MR, Ramos, K, Sommers, MS, Townsend, RR, Yu, G, Fargo, J
Nursing research. 2019;(3):246-252
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Abstract
BACKGROUND Cardiovascular disease accounts for more than half of all deaths in the hemodialysis (HD) population. Although much of this mortality is associated with fluid overload (FO), FO is difficult to measure, and many HD patients have significant pulmonary congestion despite the absence of clinical presentation. Cohort studies have observed that FO, as measured by bioimpedance spectroscopy (BIS), correlates with mortality. Other studies have observed that lower sodium intake is associated with less fluid-related weight gain, improved hypertension, and survival. Whether sodium intake influences FO in HD patients as measured by BIS is not known. OBJECTIVE The aims of the study were to determine the feasibility of assessing the impact of sodium restriction on body fluid composition as measured by BIS among patients with three levels of sodium intake and to determine if there are statistical and/or clinical differences in BIS measures across sodium intake groups. METHODS We used a double-blinded randomized controlled trial design with three levels of sodium restriction, 2,400 mg per day, 1,500 mg per day, and unrestricted (control group), to test our aims. Forty-two HD patients from a tertiary acute care academic institution associated with three urban DaVita dialysis centers were enrolled. Participants remained in the inpatient center for 5 days and 4 nights and were randomly assigned to sodium intake groups. Body fluid composition was measured with BIS. RESULTS Recruitment, enrollment, and retention statistics supported the feasibility of the study design. Regression analyses showed that there were no statistically significant differences among sodium intake groups on any of the outcomes. DISCUSSION Our data suggest the need for additional research into the effects of sodium restriction on body fluid composition.
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Early urine electrolyte patterns in patients with acute heart failure.
Collins, SP, Jenkins, CA, Baughman, A, Miller, KF, Storrow, AB, Han, JH, Brown, NJ, Liu, D, Luther, JM, McNaughton, CD, et al
ESC heart failure. 2019;(1):80-88
Abstract
AIMS: We conducted a prospective study of emergency department (ED) patients with acute heart failure (AHF) to determine if worsening HF (WHF) could be predicted based on urinary electrolytes during the first 1-2 h of ED care. Loop diuretics are standard therapy for AHF patients. A subset of patients hospitalized for AHF will develop a blunted natriuretic response to loop diuretics, termed diuretic resistance, which often leads to WHF. Early detection of diuretic resistance could facilitate escalation of therapy and prevention of WHF. METHODS AND RESULTS Patients were eligible if they had an ED AHF diagnosis, had not yet received intravenous diuretics, had a systolic blood pressure > 90 mmHg, and were not on dialysis. Urine electrolytes and urine output were collected at 1, 2, 4, and 6 h after diuretic administration. Worsening HF was defined as clinically persistent or WHF requiring escalation of diuretics or administration of intravenous vasoactives after the ED stay. Of the 61 patients who qualified in this pilot study, there were 10 (16.3%) patients who fulfilled our definition of WHF. At 1 h after diuretic administration, patients who developed WHF were more likely to have low urinary sodium (9.5 vs. 43.0 mmol; P < 0.001) and decreased urine sodium concentration (48 vs. 80 mmol/L; P = 0.004) than patients without WHF. All patients with WHF had a total urine sodium of <35.4 mmol at 1 h (100% sensitivity and 60% specificity). CONCLUSIONS One hour after diuretic administration, a urine sodium excretion of <35.4 mmol was highly suggestive of the development of WHF. These relationships require further testing to determine if early intervention with alternative agents can prevent WHF.
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Comparing the sodium excreting efficacy of furosemide and indapamide combination against furosemide and metolazone combination in congestive heart failure patients: A randomized control trial.
Salahudin, M, Shah, H, Jan, MU, Altaf, A
JPMA. The Journal of the Pakistan Medical Association. 2019;(12):1794-1799
Abstract
OBJECTIVE To compare efficacy and safety of indapamide-furosemide combination against metolazone-furosemide combination in refractory heart failure patients. METHODS The randomised controlled trial was conducted at Rehman Medical Institute, Peshawar, Pakistan, from January 1 to June 30, 2018, and comprised refractory heart failure patients who were randomised into two groups using lottery method Group 1 received intravenous furosemide 40mg Q12hr with metolazone 5mg Q24hr, while group 2 received intravenous furosemide 40mg Q12hr with indapamide 2.5mg Q24hr. Both groups were assessed for urinary sodium excretion, total urine output and decrease in weight on day one, day three and day five of admission. SPSS 22 was used for data analysis. RESULTS Of the 150 patients, there were 75(50%) in each of the two groups. Mean age in group 1 was 64.8}11.2 years, while it was 66.3}12.9 years in group 2. Both groups showed increased urinary sodium excretion and total urine output (p>0.05). Hypokalaemia was the most common adverse event 66%. Mean hospital stay was not significantly different between the groups (p>0.05). CONCLUSIONS There was no significant differences between adverse events and efficacy between patients receiving either indapamide-furosemide combination or metolazone-furosemide combination.