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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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Randomized trial of one-hour sodium bicarbonate vs standard periprocedural saline hydration in chronic kidney disease patients undergoing cardiovascular contrast procedures.
Kooiman, J, de Vries, JPM, Van der Heyden, J, Sijpkens, YWJ, van Dijkman, PRM, Wever, JJ, van Overhagen, H, Vahl, AC, Aarts, N, Verberk-Jonkers, IJAM, et al
PloS one. 2018;(2):e0189372
Abstract
BACKGROUND Guidelines advise periprocedural saline hydration for prevention of contrast induced-acute kidney injury (CI-AKI). We analysed whether 1-hour sodium bicarbonate hydration administered solely prior to intra-arterial contrast exposure is non-inferior to standard periprocedural saline hydration in chronic kidney disease (CKD) patients undergoing elective cardiovascular diagnostic or interventional contrast procedures. METHODS We performed an open-label multicentre non-inferiority trial between 2011-2014. Patients were randomized to 1 hour pre-procedure sodium bicarbonate hydration (250 ml 1.4%, N = 168) or 4-12 hours saline hydration (1000 ml 0.9%, N = 165) prior to and following contrast administration (2000 ml of saline total). Primary outcome was the relative serum creatinine increase (%) 48-96 hours post contrast exposure. Secondary outcomes were: incidence of CI-AKI (serum creatinine increase>25% or >44μmol/L), recovery of renal function, the need for dialysis, and hospital costs within two months follow-up. RESULTS Mean relative creatinine increase was 3.1% (95%CI 0.9 to 5.2%) in the bicarbonate and 1.1% (95%CI -1.2 to 3.5%) in the saline arm, mean difference 1.9% (95%CI -1.2 to 5.1%, p-non-inferiority <0.001). CI-AKI occurred in 11 (6.7%) patients randomized to sodium bicarbonate and 12 (7.5%) to saline (p = 0.79). Renal function did not fully recover in 40.0% and 44.4% of CI-AKI patients, respectively (p = 0.84). No patient required dialysis. Mean costs for preventive hydration and clinical preparation for the contrast procedure were $1158 for sodium bicarbonate vs. $1561 for saline (p < 0.001). CONCLUSION Short hydration with sodium bicarbonate prior to elective cardiovascular diagnostic or therapeutic contrast procedures is non-inferior to standard periprocedural saline hydration in CKD patients with respect to renal safety and results in considerable healthcare savings. TRIAL REGISTRATION Netherlands Trial Register (http://www.trialregister.nl/trialreg/index.asp), Nr NTR2699.
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Sodium bicarbonate improves 4 km time trial cycling performance when individualised to time to peak blood bicarbonate in trained male cyclists.
Gough, LA, Deb, SK, Sparks, SA, McNaughton, LR
Journal of sports sciences. 2018;(15):1705-1712
Abstract
The aim of this study was to investigate the effects of sodium bicarbonate (NaHCO3) on 4 km cycling time trial (TT) performance when individualised to a predetermined time to peak blood bicarbonate (HCO3-). Eleven male trained cyclists volunteered for this study (height 1.82 ± 0.80 m, body mass (BM) 86.4 ± 12.9 kg, age 32 ± 9 years, peak power output (PPO) 382 ± 22 W). Two trials were initially conducted to identify time to peak HCO3- following both 0.2 g.kg-1 BM (SBC2) and 0.3 g.kg-1 BM (SBC3) NaHCO3. Thereafter, on three separate occasions using a randomised, double-blind, crossover design, participants completed a 4 km TT following ingestion of either SBC2, SBC3, or a taste-matched placebo (PLA) containing 0.07 g.kg-1 BM sodium chloride (NaCl) at the predetermined individual time to peak HCO3-. Both SBC2 (-8.3 ± 3.5 s; p < 0.001, d = 0.64) and SBC3 (-8.6 ± 5.4 s; p = 0.003, d = 0.66) reduced the time to complete the 4 km TT, with no difference between SBC conditions (mean difference = 0.2 ± 0.2 s; p = 0.87, d = 0.02). These findings suggest trained cyclists may benefit from individualising NaHCO3 ingestion to time to peak HCO3- to enhance 4 km TT performance.
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Alkaline water improves exercise-induced metabolic acidosis and enhances anaerobic exercise performance in combat sport athletes.
Chycki, J, Kurylas, A, Maszczyk, A, Golas, A, Zajac, A
PloS one. 2018;(11):e0205708
Abstract
Hydration is one of the most significant issues for combat sports as athletes often use water restriction for quick weight loss before competition. It appears that alkaline water can be an effective alternative to sodium bicarbonate in preventing the effects of exercise-induced metabolic acidosis. Therefore, the main aim of the present study was to investigate, in a double blind, placebo controlled randomized study, the impact of mineral-based highly alkaline water on acid-base balance, hydration status, and anaerobic capacity. Sixteen well trained combat sport athletes (n = 16), were randomly divided into two groups; the experimental group (EG; n = 8), which ingested highly alkaline water for three weeks, and the control group (CG; n = 8), which received regular table water. Anaerobic performance was evaluated by two double 30 s Wingate tests for lower and upper limbs, respectively, with a passive rest interval of 3 minutes between the bouts of exercise. Fingertip capillary blood samples for the assessment of lactate concentration were drawn at rest and during the 3rd min of recovery. In addition, acid-base equilibrium and electrolyte status were evaluated. Urine samples were evaluated for specific gravity and pH. The results indicate that drinking alkalized water enhances hydration, improves acid-base balance and anaerobic exercise performance.
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Acute kidney injury: Antioxidants do not PRESERVE kidney function after contrast exposure.
Solomon, R
Nature reviews. Nephrology. 2018;(3):148-149
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Effectiveness of sodium bicarbonate infusion on mortality in septic patients with metabolic acidosis.
Zhang, Z, Zhu, C, Mo, L, Hong, Y
Intensive care medicine. 2018;(11):1888-1895
Abstract
OBJECTIVE Although sodium bicarbonate (SB) solution has been widely used in clinical practice, its effect on mortality when administered to a large population of patients with acidosis is not known. The study aimed to investigate the effectiveness of SB infusion in septic patients with metabolic acidosis. METHODS Septic patients with metabolic acidosis were identified from the Medical Information Mart for Intensive Care (MIMIC)-III database. Propensity score (PS) was used to account for the baseline differences in the probability to receive SB or not. The marginal structural Cox model (MSCM) was employed to adjust for both baseline and time-varying confounding factors. MAIN RESULTS A total of 1718 septic patients with metabolic acidosis were enrolled in the study, including 500 in the SB group and 1218 in the non-SB group. Both pH [7.16 (standard deviation (SD): 0.10) vs. 7.22 (SD: 0.07); p < 0.001] and bicarbonate concentration (BC) [11.84 (SD: 3.63) vs. 14.88 (SD: 3.36) mmol/l; p < 0.001] were significantly lower in the SB than that in the non-SB group. While there was no significant mortality effect in the overall population [hazard ratio (HR): 1.04; 95% CI 0.86-1.26; p = 0.67], SB was observed to be beneficial in patients with acute kidney injury (AKI) stage 2 or 3 and pH < 7.2 (HR 0.74; 95% CI 0.51-0.86; p = 0.021). Similar results were replicated with the MSCM. CONCLUSION Our study observed that SB infusion was not associated with improved outcome in septic patients with metabolic acidosis, but it was associated with improved survival in septic patients with AKI stage 2 or 3 and severe acidosis. The results need to be verified in randomized controlled trials.
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[Not Available].
Jermini-Gianinazzi, I
Praxis. 2018;(13):729-730
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Lessons learned from the PRESERVE trial.
Partovi, S, Trischman, T, Kang, PS
The British journal of radiology. 2018;(1087):20180092
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Abstract
The recently published Prevention of Serious Adverse Events Following Angiography (PRESERVE) trial is presently the largest and most comprehensive clinical trial comparing commonly applied strategies for prevention of iodinated contrast-induced acute kidney injury in high-risk patients. The fundamental conclusion of the PRESERVE trial is that oral acetylcysteine and i.v. sodium bicarbonate are not superior to simple i.v. hydration with isotonic saline for the prevention of contrast-induced renal sequelae. In this commentary, we discuss the results in the context of selected past major trials, and provide insights into the strengths and potential weaknesses of the PRESERVE trial. In the future, developing individualized preventive approaches to avoid contrast-induced acute kidney injury for different patient populations is recommended.
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Young man with severe metabolic acidosis after transformer oil ingestion: a case report.
Khan, FG, Zubair, SM
Journal of medical case reports. 2018;(1):290
Abstract
BACKGROUND Transformer oil is used in oil-filled transformers for its insulating as well as coolant properties. Transformer oil ingestion for attempted suicide is seldom heard of. Our patient's case presented us with a major diagnostic as well as treatment challenge because we encountered such a case for the first time and were totally unaware of the fact that methanol might make up the main component of an aged transformer oil. CASE PRESENTATION A 19-year-old Pakistani/Asian man was brought to our hospital with altered sensorium. He was found to have elevated anion gap acidosis, increased osmolal gap, and acute kidney injury. He had no evidence of rhabdomyolysis or hemolysis. Computed tomography of his head showed cerebral edema. He was resuscitated with intravenous fluids and bicarbonate. Three days later, he confessed taking transformer oil with suicidal intention. His clinical picture mimicked acute methanol intoxication. With an initial improvement in his neurological status, he started complaining of constant headache with episodes of agitation and delirium. His renal function continued worsening despite an adequate urine output. He showed a remarkable improvement in his neurological state after just one session of hemodialysis. CONCLUSIONS There is evidence that aged transformer oil contains methanol, and a patient who consumes it can present with features mimicking acute methanol intoxication.
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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.