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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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Extracellular buffer choice influences acid-base responses and gastrointestinal symptoms.
Peacock, J, Sparks, SA, Middlebrook, I, Hilton, NP, Tinnion, D, Leach, N, Saunders, B, McNaughton, LR
Research in sports medicine (Print). 2021;(6):505-516
Abstract
To compare the bicarbonate kinetics and gastrointestinal (GI) symptom responses between an equal dose of sodium bicarbonate and sodium citrate using delayed-release capsules. Thirteen active males (age 20.5 ± 2.1 y, height 1.8 ± 0.1 m and body mass [BM] 76.5 ± 9.6 kg) consumed either 0.3 g.kg-1 BM sodium bicarbonate, sodium citrate or a placebo, using a double-blind, randomized crossover design. Blood bicarbonate ion (HCO3-) concentration, pH and GI symptoms were measured pre-consumption and every 10 min for 180 min post-consumption. Blood HCO3- concentration (P < 0.001) and pH (P = 0.040) were significantly higher in the sodium bicarbonate condition compared with sodium citrate condition up to 3 h post-consumption. Peak blood HCO3- concentration was significantly higher with the sodium bicarbonate compared with citrate (P < 0.001). Mean GI symptom scores were lower (P = 0.037) for sodium citrate (1.5 ± 1.8 AU) than bicarbonate (2.6 ± 3.1 AU), with considerable inter-individual variability. No GI symptoms were reported following consumption of the placebo. Both substances increase HCO3- values significantly, with sodium bicarbonate causing significantly higher pH and HCO3- values than the same dose of sodium citrate, but results in slightly more severe GI symptoms.
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[Not Available].
Jermini-Gianinazzi, I
Praxis. 2018;(13):729-730
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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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Outcomes after Angiography with Sodium Bicarbonate and Acetylcysteine.
Weisbord, SD, Gallagher, M, Jneid, H, Garcia, S, Cass, A, Thwin, SS, Conner, TA, Chertow, GM, Bhatt, DL, Shunk, K, et al
The New England journal of medicine. 2018;(7):603-614
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BACKGROUND Intravenous sodium bicarbonate and oral acetylcysteine are widely used to prevent acute kidney injury and associated adverse outcomes after angiography without definitive evidence of their efficacy. METHODS Using a 2-by-2 factorial design, we randomly assigned 5177 patients at high risk for renal complications who were scheduled for angiography to receive intravenous 1.26% sodium bicarbonate or intravenous 0.9% sodium chloride and 5 days of oral acetylcysteine or oral placebo; of these patients, 4993 were included in the modified intention-to-treat analysis. The primary end point was a composite of death, the need for dialysis, or a persistent increase of at least 50% from baseline in the serum creatinine level at 90 days. Contrast-associated acute kidney injury was a secondary end point. RESULTS The sponsor stopped the trial after a prespecified interim analysis. There was no interaction between sodium bicarbonate and acetylcysteine with respect to the primary end point (P=0.33). The primary end point occurred in 110 of 2511 patients (4.4%) in the sodium bicarbonate group as compared with 116 of 2482 (4.7%) in the sodium chloride group (odds ratio, 0.93; 95% confidence interval [CI], 0.72 to 1.22; P=0.62) and in 114 of 2495 patients (4.6%) in the acetylcysteine group as compared with 112 of 2498 (4.5%) in the placebo group (odds ratio, 1.02; 95% CI, 0.78 to 1.33; P=0.88). There were no significant between-group differences in the rates of contrast-associated acute kidney injury. CONCLUSIONS Among patients at high risk for renal complications who were undergoing angiography, there was no benefit of intravenous sodium bicarbonate over intravenous sodium chloride or of oral acetylcysteine over placebo for the prevention of death, need for dialysis, or persistent decline in kidney function at 90 days or for the prevention of contrast-associated acute kidney injury. (Funded by the U.S. Department of Veterans Affairs Office of Research and Development and the National Health and Medical Research Council of Australia; PRESERVE ClinicalTrials.gov number, NCT01467466 .).
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[Vitamin C+sodium bicarbonate versus sodium bicarbonate alone in preventing contrast-induced nephropathy].
Laroussi, L, Triki, M, Ibn Elhaj, Z, Ben Halima, A, Boukhris, M, Ben Amara, W, Keskes, H, Kraiem, S, Lahidheb, D, Marrakchi, S, et al
Annales de cardiologie et d'angeiologie. 2017;(4):190-196
Abstract
INTRODUCTION Contrast-induced nephropathy (CIN) is a common and severe complication in interventional cardiology. OBJECTIVE The aim of our study was to compare the incidence of contrast-induced nephropathy in two accelerated hydration protocols: the first one by the serum bicarbonate and the second combining the serum bicarbonate and oral vitamin C. METHODS This is a multicenter prospective, randomized study conducted between October 2012 and May 2013, including 160 patients. RESULTS The mean age of our study population was 60.8±9.3 years (36-83 years). The two study groups were comparable in terms of cardiovascular risk factors, concomitant medication, and baseline serum creatinine. The CIN incidence was 6.3% in the vitamin C group and 10% in the control group (P=0.38). No significant difference was observed in terms of CIN incidence between the different subgroups analyzed. CONCLUSION According to our study, ascorbic acid administered orally as part of an accelerated hydration protocol does not reduce the incidence of CIN.
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Sodium bicarbonate versus isotonic saline solution to prevent contrast-induced nephropathy : a systematic review and meta-analysis.
Zapata-Chica, CA, Bello Marquez, D, Serna-Higuita, LM, Nieto-Ríos, JF, Casas-Arroyave, FD, Donado-Gómez, JH
Colombia medica (Cali, Colombia). 2015;(3):90-103
Abstract
INTRODUCTION Contrast-induced nephropathy is one of the main causes of acute kidney injury and increased hospital-acquired morbidity and mortality. The use of sodium bicarbonate for nephroprotection has emerged as a preventative strategy; however, its efficacy is controversial compared to other strategies, such as hydration using 0.9% saline solution. OBJECTIVE To compare the effectiveness of sodium bicarbonate vs. hydration using 0.9% saline solution to prevent contrast-induced acute kidney injury. METHODS A systematic review of studies registered in the COCHRANE, PUBMED, MEDLINE, LILACS, SCIELO and EMBASE databases was conducted. Randomized controlled studies that evaluated the use of 0.9% saline solution vs. sodium bicarbonate to prevent contrast-induced nephropathy were included. RESULTS A total of 22 studies (5,686 patients) were included. Sodium bicarbonate did not decrease the risk of contrast-induced nephropathy (RD= 0.00; 95% CI= -0.02 to 0.03; p= 0.83; I(2)= 0%). No significant differences were found in the demand for renal replacement therapy (RD= 0.00; 95% CI= -0.01 to 0-01; I(2)= 0%; p= 0.99) or in mortality (RD= -0.00; 95% CI= -0.001 to 0.001; I(2)= 0%; p= 0.51). CONCLUSIONS Sodium bicarbonate administration is not superior to the use of 0.9% saline solution for preventing contrast-induced nephropathy in patients with risk factors, nor is it better at reducing mortality or the need for renal replacement therapy.
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Randomized Trial of Bicarbonate or Saline Study for the Prevention of Contrast-Induced Nephropathy in Patients with CKD.
Solomon, R, Gordon, P, Manoukian, SV, Abbott, JD, Kereiakes, DJ, Jeremias, A, Kim, M, Dauerman, HL, ,
Clinical journal of the American Society of Nephrology : CJASN. 2015;(9):1519-24
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BACKGROUND AND OBJECTIVES Sodium bicarbonate has been proposed for protection of the kidney from contrast-induced AKI (CIAKI). However, the effects of bicarbonate on long-term important clinical outcomes are uncertain. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS In a prospective, double-blind, multicenter randomized clinical trial, 391 patients with an eGFR<45 ml/min per 1.73 m(2) undergoing elective coronary or peripheral angiography were randomized to an infusion with a high dose of isotonic sodium bicarbonate (target 2.0 mEq/kg) or a similar molar amount of isotonic sodium chloride. The primary outcome was a composite of mortality, dialysis, or a sustained 20% reduction in eGFR at 6 months. RESULTS There were 391 patients enrolled between March 2010 and May 2012. The incidence of the primary outcome was 14.9% in the bicarbonate group and 16.3% in the control group in the intention-to-treat population (P=0.78). There was also no difference in the incidence of CIAKI between the treatment groups (14.5% versus 12.1%, respectively; P=0.20). CIAKI was associated with a higher incidence of sustained loss of kidney function at 6 months compared with those without CIAKI (21.2% versus 7.7%, respectively; P=0.06). CONCLUSIONS High-dose sodium bicarbonate infusion in patients with eGFR<45 ml/min per 1.73 m(2) undergoing angiography did not demonstrate a difference in incidence of the composite of death, dialysis, or sustained 6-month reduction in eGFR or CIAKI compared with sodium chloride.
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Combating inadequate anesthesia in periapical infections, with sodium bicarbonate: a clinical double blind study.
Gupta, S, Mandlik, G, Padhye, MN, Kini, YK, Kakkar, S, Hire, AV
Oral and maxillofacial surgery. 2014;(3):325-9
Abstract
INTRODUCTION Local anesthetics are generally much less effective when administered in inflamed tissues. PURPOSE This study was conducted to validate the addition of sodium bicarbonate in local anesthetics to increase its effectiveness as local infiltrations in teeth associated with periapical infections. METHODS Two hundred subjects requiring extraction of maxillary teeth with periapical infections were enrolled. These subjects were divided in two groups of 100 subjects each. One group received local infiltration with 2 % lignocaine and 1:80,000 adrenaline, and the other group received local infiltration with sodium bicarbonate as an adjunct to the above mentioned local anesthetic solution. All extractions were performed using a consistent intra-alveolar technique by a single operator. Both the patient and the operator were blinded to the contents of local anesthetic solution. Data related to the onset of action of local anesthesia, pain experienced by the patient while undergoing extraction on two scales-"the visual analog scale and the verbal response scale", and any requirement of repeated injections during the procedure was recorded. RESULTS Clinical and statistical data confirmed that the addition of sodium bicarbonate in local anesthetics did increase the efficacy of local anesthesia in inflamed tissues. CONCLUSION It has been observed in this study that the action of sodium bicarbonate in local anesthetics increases the pH levels of these solutions, thus possibly making them more effective in an acidic environment.
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Comparison between three supportive treatments for prevention of contrast-induced nephropathy in high-risk patients undergoing coronary angiography.
Yeganehkhah, MR, Iranirad, L, Dorri, F, Pazoki, S, Akbari, H, Miryounesi, M, Vahedian, M, Nazeri, A, Hosseinzadeh, F, Vafaeimanesh, J
Saudi journal of kidney diseases and transplantation : an official publication of the Saudi Center for Organ Transplantation, Saudi Arabia. 2014;(6):1217-23
Abstract
Contrast-induced nephropathy is the third most common cause of acute renal failure in hospitalized patients. The purpose of this study was to compare three supportive treatments for prevention of contrast-induced nephropathy in high-risk patients undergoing coronary angiography. In this randomized clinical trial study, 150 patients with at least one risk factor, such as, congestive heart failure, history of diabetes mellitus, age>65 years or renal failure were randomly assigned to three equal groups: First group (Sodium (Na) bicarbonate infusion), second group [(N-Acetylcysteine (NAC)+Sodium Chloride (Nacl)], third group (Nacl). Angiography was performed with 350 mgI/mL of Iohexol (Omnipaque). Serum creatinine (Cr), blood blood urea nitrogen (BUN), and urine pH were measured at the start of angiography and 48 hours later. The three groups had no significant difference in demographic characteristics or other risk factors before intervention (P>0.05). Forty eight hours after exposure, the Cr level increased significantly in the Nacl group (P=0.039), while these changes were not significant in the other groups (P>0.05). The incidence of contrast-induced nephropathy was not statistically significant between all the groups (P=0.944). Although the Cr clearance had no statistically significant difference, it was lower in the NaCl group. Therefore, Na bicarbonate may be the treatment of choice in the prevention of contrast-induced nephropathy, because of less prescribed fluid volume and a lesser time required for infusion of the fluid.