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Fractional Excretion of Sodium

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81. Avibactam sodium / ceftazidime (Avycaz)

Avibactam sodium / ceftazidime (Avycaz) CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 206494Orig1s000 MEDICAL REVIEW(S) Memo to File; NDA 206494, Ceftazidime-avibactam 2 NDA 206494, Ceftazidime-avibactam was submitted by Cerexa Inc. on June 25, 2014. The Applicant proposed the following indications: 1. Complicated intra-abdominal infections (cIAI), in combination with metronidazole (MTZ), caused by Escherichia coli (including cases with concurrent bacteremia), Klebsiella (...) Pentahydrate and Avibactam Sodium 22 Figure 2: Classes of ß-lactamases and BLI Activity 24 Figure 3: Proposed Molecular Mechanism of Action of Avibactam 27 Figure 4: Chemical Structures of Clavulanic Acid, Sulbactam, Tazobactam and Avibactam 27 Figure 5: Probability of Joint Target Attainment by MIC for Enterobacteriaceae 104 Figure 6: Study Design - Resistant Pathogen Study D4280C00006 111 Figure 7: Hy’s Law Plot – Max Bilirubin by ALT and AST (ALP MIC) is the most relevant PK/PD index for ceftazidime

2015 FDA - Drug Approval Package

82. Competitive inhibition of SGLT2 by tofogliflozin or phlorizin induces urinary glucose excretion through extending splay in cynomolgus monkeys. (PubMed)

Competitive inhibition of SGLT2 by tofogliflozin or phlorizin induces urinary glucose excretion through extending splay in cynomolgus monkeys. Sodium-glucose cotransporter 2 (SGLT2) inhibitors showed a glucose lowering effect in type 2 diabetes patients through inducing renal glucose excretion. Detailed analysis of the mechanism of the glucosuric effect of SGLT2 inhibition, however, has been hampered by limitations of clinical study. Here, we investigated the mechanism of urinary glucose (...) /2 inhibitor. In a glucose titration study in cynomolgus monkeys under conditions of controlled plasma drug concentration, both tofogliflozin and phlorizin increased fractional excretion of glucose (FEG) by up to 50% under hyperglycemic conditions. By fitting the titration curve using a newly introduced method that avoids variability in estimating the threshold of renal glucose excretion, we found that tofogliflozin and phlorizin lowered the threshold and extended the splay in a dose-dependent

2014 American Journal of Physiology. Renal physiology

83. Glycosuria-mediated urinary uric acid excretion in patients with uncomplicated type 1 diabetes mellitus. (PubMed)

Glycosuria-mediated urinary uric acid excretion in patients with uncomplicated type 1 diabetes mellitus. Plasma uric acid (PUA) is associated with metabolic, cardiovascular, and renal abnormalities in patients with type 2 diabetes but is less well understood in type 1 diabetes (T1D). Our aim was to compare PUA levels and fractional uric acid excretion (FEUA) in patients with T1D vs. healthy controls (HC) during euglycemia and hyperglycemia. PUA, FEUA, blood pressure (BP), glomerular filtration (...) rate (GFR-inulin), and effective renal plasma flow (ERPF-paraaminohippurate) were evaluated in patients with T1D (n = 66) during clamped euglycemia (glucose 4-6 mmol/l) and hyperglycemia (9-11 mmol/l), and in HC (n = 41) during euglycemia. To separate the effects of hyperglycemia vs. increased glycosuria, parameters were evaluated during clamped euglycemia in a subset of T1D patients before and after sodium glucose cotransporter 2 (SGLT2) inhibition for 8 wk. PUA was lower in T1D vs. HC (228 ± 62

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2014 American Journal of Physiology. Renal physiology

84. Fractional excretion of sodium predicts worsening renal function in acute decompensated heart failure (PubMed)

Fractional excretion of sodium predicts worsening renal function in acute decompensated heart failure Renal impairment (RI), defined as an increase in creatinine level of greater than 26.5 mmol/L, develops in more than 30% of acute decompensated heart failure (ADHF) patients. Fractional excretion of sodium (FeNa) reflects sodium handling by the kidneys during diuresis.To study the relationship between FeNa and RI in patients admitted with ADHF.The hospital course and renal function of all ADHF (...) patients admitted to the hospital were prospectively observed. Patients were included if their admission creatinine level was 176 mmol/L or lower, they had been on a low-salt diet since admission, had urine sodium and creatinine samples collected more than 6 h after a furosemide dose in the first few days of admission, and they were on daily intravenous furosemide doses of 20 mg or more.Over six months, 51 patients met the inclusion criteria; the average daily dose of intravenous furosemide was 58.8 mg

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2010 Experimental & Clinical Cardiology

85. Excretion of Lipoteichoic Acid by Group A Streptococci: INFLUENCE OF PENICILLIN ON EXCRETION AND LOSS OF ABILITY TO ADHERE TO HUMAN ORAL MUCOSAL CELLS (PubMed)

obtained were analyzed by electrophoresis on sodium dodecyl sulfate polyacrylamide, thin-layer chromatography, and paper chromatography. The ability of the same materials to bind to human erythrocytes and epithelial cells was tested. The culture supernate contained lipoteichoic acid, deacylated lipoteichoic acid, glycerol phosphate, and free glycerol. Penicillin caused an increase in the amounts of each of the excreted materials. Streptococci that were stimulated with penicillin to lose (...) Excretion of Lipoteichoic Acid by Group A Streptococci: INFLUENCE OF PENICILLIN ON EXCRETION AND LOSS OF ABILITY TO ADHERE TO HUMAN ORAL MUCOSAL CELLS Group A streptococci were grown in the presence of [2-(3)H]glycerol. Concentrated suspensions of the labeled organisms were incubated with and without penicillin. [(3)H]Glycerol-labeled material accumulated in the supernates in increasing amounts with increasing concentrations of penicillin, ranging from 0 to 50 U/ml. The excretion of labeled

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1978 Journal of Clinical Investigation

86. Diuretic and anti-diuretic activities of fractions of Alismatis rhizoma. (PubMed)

Diuretic and anti-diuretic activities of fractions of Alismatis rhizoma. Alismatis rhizoma or Alisma orientale (Zexie in Chinese), the dried rhizome of Alisma orientale Juzepzuk (Alismataceae), is a well-known traditional Chinese medicine and is used as an agent for diuresis and for excreting dampness in China and Japan. In this paper, we report the diuretic activities of the petroleum ether fraction, the ethyl acetate fraction, the n-buthanol fraction, and the remaining fraction (...) , of the ethanol extract of Alismatis rhizoma (AR).The single dose of the petroleum ether fraction, the ethyl acetate fraction, the n-buthanol fraction, and the remaining fraction, of the ethanol extract of AR were orally administered to rats. Urinary excretion rate, pH and electrolyte excretion were measured in the urine of saline-loaded rats.In this study, the 100 and 400mg/kg doses of the ethyl acetate fraction and the 12.5, 25 and 50mg/kg doses of the n-butanol fraction all produced an increase in urine

2014 Journal of Ethnopharmacology

87. Pharmacokinetic Study to Investigate the Bioavailability and Tolerability of 3 Oral Formulations of Sodium Thiosulfate

release formulation first, followed by slow and fast Drug: Sodium thiosulfate oral administration of thiosulfate Experimental: Slow first Sodium thiosulfate slow release formulation first, followed by fast and medium Drug: Sodium thiosulfate oral administration of thiosulfate Outcome Measures Go to Primary Outcome Measures : Relative bioavailability of STS after oral administration based on urinary excretion of TS and sulfate [ Time Frame: 7 weeks ] Secondary Outcome Measures : Number of participants (...) with treatment-related adverse events [ Time Frame: 7 weeks ] TS excretion in urine [ Time Frame: 48 hours ] amount excreted within 48h and fraction (amount/dose) of administered thiosulfate TS excretion in urine: amount [ Time Frame: 48 hours ] amount excreted within 48h TS excretion in urine: fraction of administered TS [ Time Frame: 48 hours ] excreted / administered Sulfate excretion in urine: amount [ Time Frame: 48 hours ] amount excreted within 48h Sulfate excretion in urine: fraction of administered

2015 Clinical Trials

88. Dietary sodium adherence is poor in chronic heart failure patients. (PubMed)

Dietary sodium adherence is poor in chronic heart failure patients. We sought to determine the rates and predictors of dietary sodium restriction and to evaluate the reliability of 24-hour urine collection as a tool to estimate dietary sodium intake in heart failure (HF) patients.We evaluated the 24-hour urinary sodium excretion of 305 outpatients with HF and reduced ejection fraction who were educated on following a <2 g sodium diet. The mean sodium excretion according to a single sample from (...) each participant was 3.15 ± 1.58 g, and 23% were adherent to the <2 g recommendation. One hundred sixty-eight participants provided 2 samples with urinary creatinine excretion within normative range. Averaging both resulted in a mean sodium excretion of 3.21 ± 1.20 g and lower adherence rates to the <2-gram diet: 14% versus 23% (P = .019). Multivariate logistic regression showed only male sex and higher body mass index (BMI) to be associated with nonadherence (male: odds ratio [OR] 2.20, 95

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2015 Journal of cardiac failure

89. Effects of Family Sodium Watcher Program on Outcomes in Heart Failure Patient-Family Caregiver Dyads

-hour urinary sodium excretion at 3 time points at baseline, 4-months, and 12 months. Data will be presented as the changes of sodium excretion level over 12 months. Secondary Outcome Measures : All cause hospitalization/mortality [ Time Frame: 12 months ] Data for all events of hospitalizations and mortality will be collected from the baseline to 12 months follow up. Time from baseline to each event will be calculated. Data will be presented as time to first event. Eligibility Criteria Go (...) Effects of Family Sodium Watcher Program on Outcomes in Heart Failure Patient-Family Caregiver Dyads Effects of Family Sodium Watcher Program on Outcomes in Heart Failure Patient-Family Caregiver Dyads - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please

2015 Clinical Trials

90. The Effect of Sodium Nitrite on Renal Function and Blood Pressure in Hypertensive Versus Healthy Subjects

nitrite Sodium nitrite, 240 micrograms/kg/hour for 2 hours Drug: Sodium nitrite Sodium nitrite, 240 micrograms/kg/hour for 2 hours Other Name: NaNO2 Placebo Comparator: Placebo Sodium chloride, isotonic 0.9%, 25 ml/hour for 2 hours Drug: Sodium chloride Sodium chloride, isotonic 0.9%, 25 ml/hour for 2 hours Other Name: NaCl Outcome Measures Go to Primary Outcome Measures : Fractional urinary sodium excretion (FENa) [ Time Frame: 1 day ] Secondary Outcome Measures : Peripheral (brachial) blood pressure (...) , vasoactive hormones and central blood pressure are previously unexamined. It is now possible to achieve serial estimations of the central aortic systolic pressure (CASP) by a wrist born device. Hypothesis: Sodium nitrite infusion increases the urinary sodium excretion and glomerular filtration rate (GFR) Sodium nitrite infusion increases plasma levels of nitrite, nitrate, NO and cyclic guanosine monophosphate (cGMP) Sodium nitrite infusion lowers the peripheral and central blood pressure Renal clearance

2015 Clinical Trials

91. The effect of puberty on diurnal sodium regulation. (PubMed)

every 4 h, and the urine was collected in fractions. Blood pressure and heart rate were noninvasively monitored. Atrial natriuretic peptide (ANP), angiotensin II, aldosterone, and renin were measured in blood. Children in puberty had lower plasma levels of renin (P<0.05) and angiotensin II (P<0.05) and a 26% reduction in filtered sodium without changes in sodium excretion compared with prepuberty children. A circadian rhythm in sodium excretion, the renin-angiotensin system, ANP, and blood pressure (...) The effect of puberty on diurnal sodium regulation. The aim of this study was to investigate the impact of sex and puberty stage on circadian changes in sodium excretion, sodium-regulating hormones, and hemodynamics. Thirty-nine healthy volunteers (9 prepuberty boys, 10 prepuberty girls, 10 puberty boys, and 10 puberty girls) were included. They all underwent a 24-h circadian in-patient study under standardized conditions regarding activity, diet, and fluid intake. Blood samples were drawn

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2015 American Journal of Physiology. Renal physiology

92. Sodium Intake in Chronic Kidney Disease (STICK)

Frame: 24 months ] Change in 24-hour urinary protein from baseline to final visit [ Time Frame: 24 months ] Increase in risk category for prognosis of CKD as measured by the KDIGO 2012 CKD classification table [ Time Frame: 24 months ] Change in 24-hour urinary sodium excretion from baseline to final visit [ Time Frame: 24 months ] Change in mean systolic and diastolic blood pressure from 24-hour ambulatory blood pressure monitoring completed at baseline and final visit [ Time Frame: 24 months (...) -infectious glomerulonephritis, IgA nephropathy, thin basement membrane disease, Henoch-Schonlein purpura, proliferative glomerulonephritis, membranous nephropathy (including lupus nephritis), rapidly progressive glomerulonephritis, minimal change disease, or focal segmental glomerulosclerosis Prior or planned renal transplantation Prior, current or planned renal dialysis Medical diagnosis known to be associated with abnormal renal sodium excretion, including Bartter syndrome, SIADH, diabetes insipidus

2015 Clinical Trials

93. Physical and Functional Links between Anion Exchanger-1 and Sodium Pump. (PubMed)

kidney membrane proteins showed that the last 11 residues of AE1 are important for β1 binding. siRNA-induced knockdown of β1 in cell culture resulted in a significant reduction in kidney AE1 levels at the cell membrane, whereas overexpression of kidney AE1 increased cell surface sodium pump levels. Notably, membrane staining of β1 was reduced throughout collecting ducts of AE1-null mouse kidney, where increased fractional excretion of sodium has been reported. These data suggest a requirement of β1 (...) an important role in its polarized membrane residency. We have identified the β1 subunit of Na(+),K(+)-ATPase (sodium pump) as a binding partner for AE1 in the human kidney. Kidney AE1 and β1 colocalized in renal α-intercalated cells and coimmunoprecipitated (together with the catalytic α1 subunit of the sodium pump) from human kidney membrane fractions. ELISA and fluorescence titration assays confirmed that AE1 and β1 interact directly, with a Kd value of 0.81 μM. GST-AE1 pull-down assays using human

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2014 Journal of the American Society of Nephrology

94. Rho kinase inhibition mitigates sunitinib-induced rise in arterial pressure and renal vascular resistance but not increased renal sodium reabsorption. (PubMed)

by 30 mmHg and 5 mmHg × ml × min × g kidney weight, respectively, accompanied by reduced glomerular filtration rate and fractional Na+ excretion with unaffected fractional Li+ excretion. ROCK inhibition blunted sunitinib-induced hypertension and prevented the early rise in RVR, but not the decrease in fractional Na+ excretion, which may explain its modest effect on sunitinib-induced hypertension.Our data indicate that early sunitinib-induced hypertension is associated with modest alterations (...) Rho kinase inhibition mitigates sunitinib-induced rise in arterial pressure and renal vascular resistance but not increased renal sodium reabsorption. The therapeutic use of the vascular endothelial growth factor (VEGF) antagonist sunitinib is limited by sunitinib-induced hypertension. The hypotheses were tested that sunitinib increases renal vascular resistance (RVR) and renal Na+ reabsorption, and that Rho kinase (ROCK) inhibition blunts sunitinib-induced hypertension.Sunitinib actions

2014 Journal of Hypertension

95. Effect of vasopressin antagonism on renal handling of sodium and water and central and brachial blood pressure during inhibition of the nitric oxide system in healthy subjects. (PubMed)

-NMMA).Nineteen healthy subjects were enrolled in a randomized, placebo-controlled, double-blind, crossover study of two examination days. Tolvaptan 15 mg or placebo was given in the morning. L-NMMA was given as a bolus followed by continuous infusion during 60 minutes. We measured urine output(UO), free water clearance (CH2O), fractional excretion of sodium (FENa), urinary aquaporin-2 channels (u-AQP2) and epithelial sodium channels (u-ENaCγ), plasma vasopressin (p-AVP), central and brachial blood (...) Effect of vasopressin antagonism on renal handling of sodium and water and central and brachial blood pressure during inhibition of the nitric oxide system in healthy subjects. Tolvaptan is a selective vasopressin receptor antagonist (V2R) that increases free water excretion. We wanted to test the hypotheses that tolvaptan changes both renal handling of water and sodium and systemic hemodynamics during basal conditions and during nitric oxide (NO)-inhibition with L-NG-monomethyl-arginine (L

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2014 BMC nephrology

96. BASAL RENAL OXYGEN CONSUMPTION AND THE EFFICIENCY OF OXYGEN UTILIZATION FOR SODIUM REABSORPTION. (PubMed)

the best possible estimate of the fractional contribution of Vo2(basal) to Vo2(total) under physiological conditions (basal percent renal Vo2). Estimates of basal percent renal Vo2 from 24 studies varied from 0% to 81.5%. Basal percent renal Vo2 varied with the fractional excretion of Na(+) (FENa(+)) in the 14 studies in which FENa(+) was measured under control conditions. Linear regression analysis predicted a basal percent renal Vo2 of 12.7-16.5% when FENa(+) = 1% (r(2) = 0.48, P = 0.001 (...) BASAL RENAL OXYGEN CONSUMPTION AND THE EFFICIENCY OF OXYGEN UTILIZATION FOR SODIUM REABSORPTION. We examined how the presence of a fixed level of basal renal O2 consumption (Vo2(basal); O2 used for processes independent of Na(+) transport) confounds the utility of the ratio of Na(+) reabsorption (TNa(+)) to total renal Vo2 (Vo2(total)) as an index of the efficiency of O2 utilization for TNa(+). We performed a systematic review and additional experiments in anesthetized rabbits to obtain

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2014 American Journal of Physiology. Renal physiology

97. Pharmacokinetics of Bisacodyl or Sodium Picosulfate Administered Orally in Healthy Lactating Females

Sponsor: Boehringer Ingelheim Information provided by (Responsible Party): Boehringer Ingelheim Study Details Study Description Go to Brief Summary: To investigate if bisacodyl (Dulcolax®) and sodium picosulfate (Laxoberal®) is excreted in breast milk of healthy lactating women after an oral administration of 10 mg once daily over a period of 8 days. Condition or disease Intervention/treatment Phase Healthy Drug: Bisacodyl Drug: Sodium picosulfate Phase 1 Study Design Go to Layout table for study (...) Pharmacokinetics of Bisacodyl or Sodium Picosulfate Administered Orally in Healthy Lactating Females Pharmacokinetics of Bisacodyl or Sodium Picosulfate Administered Orally in Healthy Lactating Females - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please

2014 Clinical Trials

98. Kynamro - mipomersen sodium

Kynamro - mipomersen sodium London, 21 March 2013 EMA/305826/2013 Committee for Medicinal Products for Human Use (CHMP) Assessment report Kynamro Solution for injection 189mg International non-proprietary name: mipomersen Procedure No. EMEA/H/C/002429/0000 Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 (...) in cardiovascular morbidity and mortality. Although most clinical studies have been conducted with the statins, other mechanisms of action that lower LDL-C might also contribute to the reduction in morbidity and mortality in a similar fashion. Kynamro contains mipomersen (as mipomersen sodium), an antisense oligonucleotide drug targeted to human messenger ribonucleic acid (mRNA) for apo B-100, the principal apolipoprotein of LDL and its metabolic precursor, very low density lipoprotein (VLDL). It inhibits

2013 European Medicines Agency - EPARs

99. An Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK1265744 Administered as a Single Oral Dose and a Study to Describe the Pharmacokinetics of a Supratherapeutic Dose of GSK1265744 in Healthy Adult Subjects

An Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK1265744 Administered as a Single Oral Dose and a Study to Describe the Pharmacokinetics of a Supratherapeutic Dose of GSK1265744 in Healthy Adult Subjects An Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK1265744 Administered as a Single Oral Dose and a Study to Describe the Pharmacokinetics of a Supratherapeutic Dose of GSK1265744 in Healthy Adult Subjects - Full Text View (...) - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. An Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK1265744 Administered as a Single Oral Dose and a Study to Describe the Pharmacokinetics of a Supratherapeutic Dose

2013 Clinical Trials

100. Effects of increased sodium delivery on distal tubular sodium reabsorption with and without volume expansion in man (PubMed)

was lower and fractional sodium excretion higher during saline diuresis compared to acetazolamide diuresis; (b) although free water clearance was moderately reduced by chlorothiazide at low rates of urine flow, there was no difference in free water clearance between saline loading alone and saline plus chlorothiazide at high rates of urine flow; and (c) during saline loading free water clearance rose without evidence of a limit when increased distal delivery was accompanied by spontaneous increases (...) in glomerular filtration rate, but tended toward a limit when glomerular filtration rate remained constant. The data indicate that during acute volume expansion with saline, there is a decrease in the fraction of delivered sodium reabsorbed in the distal nephron when compared to the response of the distal nephron to comparable increases in distal sodium delivery in the absence of volume expansion.

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1970 Journal of Clinical Investigation

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