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1.
Sodium Bicarbonate Prescription and Extracellular Volume Increase: Real-world Data Results from the AlcalUN Study.
Beaume, J, Figueres, L, Bobot, M, de Laforcade, L, Ayari, H, Dolley-Hitze, T, Gueutin, V, Braconnier, A, Golbin, L, Citarda, S, et al
Clinical pharmacology and therapeutics. 2022;(1):252-262
Abstract
Oral alkalization with sodium bicarbonate (NaHCO3 ) or citrate is prescribed for conditions ranging from metabolic acidosis to nephrolithiasis. Although most nephrologists/urologists use this method routinely, extracellular volume (ECV) increase is the main feared adverse event reported for NaHCO3 . Thus far, no trial has specifically studied this issue in a real-world setting. AlcalUN (NCT03035812) is a multicentric, prospective, open-label cohort study with nationwide (France) enrollment in 18 (public and private) nephrology/urology units. Participants were adult outpatients requiring chronic (>1 month) oral alkalization by either NaHCO3 -containing or no-NaHCO3 -containing agents. The ECV increase (primary outcome) was judged based on body weight increase (ΔBW), blood pressure increase (ΔBP), and/or new-onset edema at the first follow-up visit (V1). From February 2017 to February 2020, 156 patients were enrolled. After a median 106 days of treatment, 91 (72%) patients reached the primary outcome. They had lower systolic (135 (125, 141) vs. 141 (130, 150), P = 0.02) and diastolic (77 (67, 85) vs. 85 (73, 90), P = 0.03) BP values, a higher plasma chloride (106.0 (105.0, 109.0) vs. 105.0 (102.0, 107.0), P = 0.02) at baseline, and a less frequent history of nephrolithiasis (32 vs. 56%, P = 0.02). Patients experienced mainly slight ΔBP (< 10 mmHg). The primary outcome was not associated (P = 0.79) with the study treatment (129 received NaHCO3 and 27 received citrate). We subsequently developed three different models of propensity score matching; each confirmed our results. Chronic oral alkalization with NaHCO3 is no longer associated with an ECV increase compared to citrate in real-life settings.
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2.
The gender dependent influence of sodium bicarbonate supplementation on anaerobic power and specific performance in female and male wrestlers.
Durkalec-Michalski, K, Zawieja, EE, Zawieja, BE, Michałowska, P, Podgórski, T
Scientific reports. 2020;(1):1878
Abstract
The aim of this study was the assessment of progressive low-dose sodium bicarbonate (NaHCO3) supplementation on the anaerobic indices in two bouts of Wingate tests (WT) separated by wrestling-specific performance test and assessing the gender differences in response. Fifty-one (18 F) wrestlers completed a randomized trial of either a NaHCO3 (up to 100 mg·kg-1) or a placebo for 10 days. Before and after treatment, athletes completed an exercise protocol that comprised, in sequence, the first WT1, dummy throw test (DT), and second WT2. The number of completed throws increased significantly in males from 19.3 ± 2.6 NaHCO3pre to 21.7 ± 2.9 NaHCO3post. ΔWT2-WT1 improved particularly in the midsection of 30-s WT on NaHCO3. However, no significant differences were found in peak power (PP), power drop (PD) and average power (AP) (analyzed separately for each WT), and ΔWT2-WT1 in PP and PD. Interaction with gender was significant for AP, PP and PD, every second of WT1 and WT2, as well as DT test. In conclusion, our study suggests that the response to NaHCO3 may be gender-specific and progressive low-dose NaHCO3 supplementation allows the advantageous strengthening of wrestling-specific performance in males. It can also lead to maintenance of high anaerobic power mainly in the midsection of the 30-s Wingate test.
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3.
Correction of metabolic acidosis improves muscle mass and renal function in chronic kidney disease stages 3 and 4: a randomized controlled trial.
Dubey, AK, Sahoo, J, Vairappan, B, Haridasan, S, Parameswaran, S, Priyamvada, PS
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association. 2020;(1):121-129
Abstract
BACKGROUND Metabolic acidosis (MA) is associated with a loss of muscle mass and faster deterioration of kidney function in patients with chronic kidney disease (CKD). A few single-centre randomized trials have reported favourable outcomes following correction of MA. Additional good quality evidence on the safety and efficacy of alkali supplementation is required in epidemiologically different patient subsets with CKD. METHODS A single-centre, open-label, randomized, prospective parallel-group study was conducted to assess the effect of correction of MA on body composition and kidney function. A total of 188 patients with CKD stages 3 and 4, with venous bicarbonate levels <22 mEq/L were randomized. The intervention arm received standard care as per Kidney Disease: Improving Global Outcomes (KDIGO) 2012 guidelines along with oral sodium bicarbonate supplementation to maintain venous bicarbonate levels at 24-26 mEq/L, whereas the control group received standard care alone. The mid-arm muscle circumference (MAMC), lean body mass (LBM) and estimated glomerular filtration rate (eGFR) were compared between the groups at the end of 6 months. RESULTS The intervention arm showed a higher LBM {36.8 kg [95% confidence interval (CI) 36.5-37.1] versus 36 [35.7-36.4]; P = 0.002} and MAMC [22.9 cm (95% CI 22.8-23) versus 22.6 (22.5-22.7); P = 0.001] when compared with the control group. The GFR in the intervention arm was higher [32.74 mL/1.73 m2 (95% CI 31.5-33.9) versus 28.2 (27-29.4); P ≤ 0.001]. A rapid decline in GFR was documented in 39 (41.5%) patients in the control arm and 19 (20.2%) patients in the intervention arm (P = 0.001). CONCLUSIONS Alkali supplementation to increase venous bicarbonate levels to 24-26 mEq/L is associated with preservation of LBM and kidney function in patients with CKD stages 3 and 4.
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4.
Sodium bicarbonate therapy for patients with severe metabolic acidaemia in the intensive care unit (BICAR-ICU): a multicentre, open-label, randomised controlled, phase 3 trial.
Jaber, S, Paugam, C, Futier, E, Lefrant, JY, Lasocki, S, Lescot, T, Pottecher, J, Demoule, A, Ferrandière, M, Asehnoune, K, et al
Lancet (London, England). 2018;(10141):31-40
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Abstract
BACKGROUND Acute acidaemia is frequently observed during critical illness. Sodium bicarbonate infusion for the treatment of severe metabolic acidaemia is a possible treatment option but remains controversial, as no studies to date have examined its effect on clinical outcomes. Therefore, we aimed to evaluate whether sodium bicarbonate infusion would improve these outcomes in critically ill patients. METHODS We did a multicentre, open-label, randomised controlled, phase 3 trial. Local investigators screened eligible patients from 26 intensive care units (ICUs) in France. We included adult patients (aged ≥18 years) who were admitted within 48 h to the ICU with severe acidaemia (pH ≤7·20, PaCO2 ≤45 mm Hg, and sodium bicarbonate concentration ≤20 mmol/L) and with a total Sequential Organ Failure Assessment score of 4 or more or an arterial lactate concentration of 2 mmol/L or more. We randomly assigned patients (1:1), by stratified randomisation with minimisation via a restricted web platform, to receive either no sodium bicarbonate (control group) or 4·2% of intravenous sodium bicarbonate infusion (bicarbonate group) to maintain the arterial pH above 7·30. Our protocol recommended that the volume of each infusion should be within the range of 125-250 mL in 30 min, with a maximum of 1000 mL within 24 h after inclusion. Randomisation criteria were stratified among three prespecified strata: age, sepsis status, and the Acute Kidney Injury Network (AKIN) score. The primary outcome was a composite of death from any cause by day 28 and the presence of at least one organ failure at day 7. All analyses were done on data from the intention-to-treat population, which included all patients who underwent randomisation. This study is registered with ClinicalTrials.gov, number NCT02476253. FINDINGS Between May 5, 2015, and May 7, 2017, we enrolled 389 patients into the intention-to-treat analysis in the overall population (194 in the control group and 195 in the bicarbonate group). The primary outcome occurred in 138 (71%) of 194 patients in the control group and 128 (66%) of 195 in the bicarbonate group (absolute difference estimate -5·5%, 95% CI -15·2 to 4·2; p=0·24). The Kaplan-Meier method estimate of the probability of survival at day 28 between the control group and bicarbonate group was not significant (46% [95% CI 40-54] vs 55% [49-63]; p=0·09. In the prespecified AKIN stratum of patients with a score of 2 or 3, the Kaplan-Meier method estimate of survival by day 28 between the control group and bicarbonate group was significant (37% [95% CI 28-48] vs 54% [45-65]; p=0·0283). [corrected] Metabolic alkalosis, hypernatraemia, and hypocalcaemia were observed more frequently in the bicarbonate group than in the control group, with no life-threatening complications reported. INTERPRETATION In patients with severe metabolic acidaemia, sodium bicarbonate had no effect on the primary composite outcome. However, sodium bicarbonate decreased the primary composite outcome and day 28 mortality in the a-priori defined stratum of patients with acute kidney injury. FUNDING French Ministry of Health and the Société Française d'Anesthésie Réanimation.
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Efficacy of Plantago major, chlorhexidine 0.12% and sodium bicarbonate 5% solution in the treatment of oral mucositis in cancer patients with solid tumour: A feasibility randomised triple-blind phase III clinical trial.
Cabrera-Jaime, S, Martínez, C, Ferro-García, T, Giner-Boya, P, Icart-Isern, T, Estrada-Masllorens, JM, Fernández-Ortega, P
European journal of oncology nursing : the official journal of European Oncology Nursing Society. 2018;:40-47
Abstract
PURPOSE Oral mucositis is one of the most common adverse effects of chemotherapy and radiotherapy. The aim of this study was to compare the efficacy of Plantago major extract versus chlorhexidine 0.12% versus sodium bicarbonate 5% in the symptomatic treatment of chemotherapy-induced oral mucositis in solid tumour cancer patients. METHOD Multicentre randomised controlled trial estimated sample of 45 solid tumour patients with grade II-III mucositis. The participants were randomised to one of three treatments, consisting of sodium bicarbonate 5% aqueous solution together with: an additional dose of sodium bicarbonate 5% aqueous solution, Plantago major extract, or chlorhexidine 0.12%. The primary outcomes were severity of mucositis, pain intensity, oral intake capacity and quality of life. The independent variable was treatment group, and confounders included sociodemographic data, neutrophil count, chemotherapy drug and dose received. RESULTS Of the 50 patients enrolled, 68% (n = 34) achieved grade 0 mucositis (none), with those using the double sodium bicarbonate rinse healing in five days on average (95% CI 3.9, 6.5) versus seven days (95% CI 5.3, 9,0) for the chlorhexidine group and seven days (95% CI 5.3, 8.5) for the Plantago major group. The pain experienced by the participants lessened over the 14 days of treatment, but differences in pain intensity between the three groups did not show statistical significance (p = 0.762). CONCLUSIONS Healing time was shorter with the double sodium bicarbonate solution compared to the other two rinses, but the differences were not significant. Our results suggest it may be time to reconsider the use of Plantago major extract in the management of oral mucositis.
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Sodium bicarbonate infusion in patients undergoing orthotopic liver transplantation: a single center randomized controlled pilot trial.
Weinberg, L, Broad, J, Pillai, P, Chen, G, Nguyen, M, Eastwood, GM, Scurrah, N, Nikfarjam, M, Story, D, McNicol, L, et al
Clinical transplantation. 2016;(5):556-65
Abstract
BACKGROUND Liver transplantation-associated acute kidney injury (AKI) carries significant morbidity and mortality. We hypothesized that sodium bicarbonate would reduce the incidence and/or severity of liver transplantation-associated AKI. METHODS In this double-blinded pilot RCT, adult patients undergoing orthotopic liver transplantation were randomized to an infusion of either 8.4% sodium bicarbonate (0.5 mEq/kg/h for the first hour; 0.15 mEq/kg/h until completion of surgery); (n = 30) or 0.9% sodium chloride (n = 30). PRIMARY OUTCOME AKI within the first 48 h post-operatively. RESULTS There were no significant differences between the two treatment groups with regard to baseline characteristics, model for end-stage liver disease and acute physiology and chronic health evaluation (APACHE) II scores, and pre-transplantation renal function. Intra-operative factors were similar for duration of surgery, blood product requirements, crystalloid and colloid volumes infused and requirements for vasoactive therapy. Eleven patients (37%) in the bicarbonate group and 10 patients (33%) in the sodium chloride group developed a post-operative AKI (p = 0.79). Bicarbonate infusion attenuated the degree of immediate post-operative metabolic acidosis; however, this effect dissipated by 48 h. There were no significant differences in ventilation hours, ICU or hospital length of stay, or mortality. CONCLUSIONS The intra-operative infusion of sodium bicarbonate did not decrease the incidence of AKI in patients following orthotopic liver transplantation.
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Lactate Clearance and Vasopressor Seem to Be Predictors for Mortality in Severe Sepsis Patients with Lactic Acidosis Supplementing Sodium Bicarbonate: A Retrospective Analysis.
Lee, SM, Kim, SE, Kim, EB, Jeong, HJ, Son, YK, An, WS
PloS one. 2015;(12):e0145181
Abstract
INTRODUCTION Initial lactate level, lactate clearance, C-reactive protein, and procalcitonin in critically ill patients with sepsis are associated with hospital mortality. However, no study has yet discovered which factor is most important for mortality in severe sepsis patients with lactic acidosis. We sought to clarify this issue in patients with lactic acidosis who were supplementing with sodium bicarbonate. MATERIALS AND METHODS Data were collected from a single center between May 2011 and April 2014. One hundred nine patients with severe sepsis and lactic acidosis who were supplementing with sodium bicarbonate were included. RESULTS The 7-day mortality rate was 71.6%. The survivors had higher albumin levels and lower SOFA, APACHE II scores, vasopressor use, and follow-up lactate levels at an elapsed time after their initial lactate levels were checked. In particular, a decrement in lactate clearance of at least 10% for the first 6 hours, 24 hours, and 48 hours of treatment was more dominant among survivors than non-survivors. Although the patients who were treated with broad-spectrum antibiotics showed higher illness severity than those who received conventional antibiotics, there was no significant mortality difference. 6-hour, 24-hour, and 48-hour lactate clearance (HR: 4.000, 95% CI: 1.309-12.219, P = 0.015) and vasopressor use (HR: 4.156, 95% CI: 1.461-11.824, P = 0.008) were significantly associated with mortality after adjusting for confounding variables. CONCLUSIONS Lactate clearance at a discrete time point seems to be a more reliable prognostic index than initial lactate value in severe sepsis patients with lactic acidosis who were supplementing with sodium bicarbonate. Careful consideration of vasopressor use and the initial application of broad-spectrum antibiotics within the first 48 hours may be helpful for improving survival, and further study is warranted.
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Sodium bicarbonate infusion to reduce cardiac surgery-associated acute kidney injury: a phase II multicenter double-blind randomized controlled trial.
McGuinness, SP, Parke, RL, Bellomo, R, Van Haren, FM, Bailey, M
Critical care medicine. 2013;(7):1599-607
Abstract
OBJECTIVES Cardiac surgery-associated acute kidney injury occurs in up to 50% of patients and is associated with increased mortality and morbidity. This study aimed to discover if perioperative urinary alkalinization with sodium bicarbonate infusion reduces the prevalence of cardiac surgery-associated acute kidney injury. DESIGN This study was a phase IIb multicenter double-blind randomized controlled trial. SETTING This study was conducted in three tertiary hospitals in New Zealand and Australia. PATIENTS A total of 427 patients scheduled to undergo elective cardiac surgery, who were at increased risk of development of cardiac surgery-associated acute kidney injury using recognized risk factors. MEASUREMENTS AND MAIN RESULTS Patients were randomly allocated to receive either sodium bicarbonate (n = 215) or sodium chloride (n = 212) infusion, commencing at the start of anesthesia, in a dose of 0.5 mEq/kg/hr for the first hour and then 0.2 mmol/kg/hr for 23 hours. The primary outcome measure was the number of patients with development of cardiac surgery-associated acute kidney injury, defined as an increase in creatinine greater than 25% or 0.5 mg/dL (44 µmol/L) from baseline to peak value within the first five postoperative days. Significant differences among the groups in both plasma and urinary biochemistry were achieved 6 hours after commencement of the infusion, and these changes persisted for more than 24 hours. A total of 100 out of 215 patients (47% [95% CI, 40%-53%]) in the sodium bicarbonate group and 93 of 212 patients (44% [95% CI, 37%-51%]) in the sodium chloride group with development of acute kidney injury within the first five postoperative days (p = 0.58). There were also no significant differences in ventilation hours, ICU or hospital length of stay, or mortality. CONCLUSIONS Perioperative alkalinization of blood and urine using an infusion of sodium bicarbonate did not result in a decrease in the prevalence of acute kidney injury in patients following cardiac surgery.
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Post-dilution on line haemodiafiltration with citrate dialysate: first clinical experience in chronic dialysis patients.
Panichi, V, Fiaccadori, E, Rosati, A, Fanelli, R, Bernabini, G, Scatena, A, Pizzarelli, F
TheScientificWorldJournal. 2013;:703612
Abstract
BACKGROUND Citrate has anticoagulative properties and favorable effects on inflammation, but it has the potential hazards of inducing hypocalcemia. Bicarbonate dialysate (BHD) replacing citrate for acetate is now used in chronic haemodialysis but has never been tested in postdilution online haemodiafiltration (OL-HDF). METHODS Thirteen chronic stable dialysis patients were enrolled in a pilot, short-term study. Patients underwent one week (3 dialysis sessions) of BHD with 0.8 mmol/L citrate dialysate, followed by one week of postdilution high volume OL-HDF with standard bicarbonate dialysate, and one week of high volume OL-HDF with 0.8 mmol/L citrate dialysate. RESULTS In citrate OL-HDF pretreatment plasma levels of C-reactive protein and β 2-microglobulin were significantly reduced; intra-treatment plasma acetate levels increased in the former technique and decreased in the latter. During both citrate techniques (OL-HDF and HD) ionized calcium levels remained stable within the normal range. CONCLUSIONS Should our promising results be confirmed in a long-term study on a wider population, then OL-HDF with citrate dialysate may represent a further step in improving dialysis biocompatibility.
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The effect of Parodontax® on the MMP-8 concentration in gingivitis patients.
Ehlers, V, Helm, S, Kasaj, A, Willershausen, B
Schweizer Monatsschrift fur Zahnmedizin = Revue mensuelle suisse d'odonto-stomatologie = Rivista mensile svizzera di odontologia e stomatologia. 2011;(11):1041-51
Abstract
The aim of the study was to evaluate the efficacy of Parodontax® (GlaxoSmith-Kline, Bühl, Germany) on the signs gingival inflammation and the enzyme activity of matrix metalloproteinase-8 (aMMP-8) in the gingival crevicular fluid. After approval by the ethics commission, a total of 50 volunteers participated in the study; group 1 (n = 25, age: 43 ± 12 years) with moderate gingivitis (BOP +) and group 2 (n = 25, age: 29 ± 11 years) with clinically healthy gingival conditions (BOP -). After obtaining anamnestic data, the dental examination included assessment of oral hygiene (Quigley & Hein 1962), gingival inflammation (Saxer & Mühlemann 1975), probing pocket depth and clinical attachment level. Gingival crevicular fluid was collected from both groups. A quantitative assessment of aMMP-8 in the gingival crevicular fluid samples was performed (DentoAnalyzer, Dentognostics GmbH, Jena, Germany). Study participants were instructed to use only Parodontax®. After three weeks, all parameters were measured again. The aMMP-8 values of group 1 were significantly reduced after the use of Parodontax® toothpaste and mouthwash (p < 0.001; baseline median 41.25 ± 38.16 ng/ml, final post-treatment median 7.73 ± 7.58 ng/ml aMMP-8 eluate; group 2: baseline median 3.75 ± 3.16 ng/ml, final post-treatment median 3.73 ± 1.54 ng/ml aMMP-8 eluate). Gingival inflammation and plaque accumulation were reduced. It was shown that Parodontax® was effective in reducing the enzymatic activity of inflammation.