Sodium bicarbonate in 5% dextrose: can clinicians tell the difference?

2020 ◽  
Vol 22 (1) ◽  
pp. 80-82
Author(s):  
Briony Jude ◽  
◽  
Thummaporn Naorungroj ◽  
Ary Serpa Neto ◽  
Tomoko Fujii ◽  
...  
Keyword(s):  
Metabolic Acidosis ◽  
Sodium Bicarbonate ◽  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Double Blind ◽  
Icu Patients ◽  
Bicarbonate Therapy ◽  
The Difference ◽  
Randomised Controlled ◽  
Intravenous Sodium

BACKGROUND: Due to the lack of double-blind randomised controlled trials, the true effect of intravenous sodium bicarbonate therapy in ICU patients with metabolic acidosis remains unclear. METHODS: We diluted 100 mL 8.4% sodium bicarbonate in 150 mL 5% dextrose (D5W) within a 250 mL polyolefin bag after removing 100 mL. We asked ICU clinicians to inspect a 250 mL bag containing sodium bicarbonate or a 250 mL bag where 100 mL of D5W had been removed and then returned. The bags were attached to intravenous giving sets. We asked participants to identify the contents of the bags. RESULTS: Among 60 participants (39 nursing staff [65%], 20 medical staff [33.3%] and one pharmacist), 36 (60%) answered correctly. The Cohen κ for agreement between test bag content and participants' answers was 0.20 (95% CI, −0.05 to 0.45; P = 0.12), implying the answers were correct by chance. In the group of 28 participants who indicated they used a clue to help them decide their answer, 15 (53.6%) answered correctly, whereas in the remainder (n = 32), 21 (65.6%) answered correctly (P = 0.49). CONCLUSION: When 100 mL of 8.4% sodium bicarbonate were diluted in 150 mL of D5W within a 250 mL polyolefin bag, clinicians were unable to correctly identify the contents of the bags. Our findings imply that sodium bicarbonate therapy can be successfully blinded.

scholarly journals Oral Bicarbonate Therapy in Non-Haemodialysis Dependent Chronic Kidney Disease Patients: A Systematic Review and Meta-Analysis of Randomised Controlled Trials

2019 ◽  
Vol 8 (2) ◽  
pp. 208 ◽  
Author(s):  
May Khei Hu ◽  
Miles D. Witham ◽  
Roy L. Soiza
Keyword(s):  
Systematic Review ◽  
Chronic Kidney Disease ◽  
Metabolic Acidosis ◽  
Kidney Disease ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Mean Difference ◽  
Controlled Trials ◽  
Bicarbonate Therapy ◽  
Randomised Controlled

Metabolic acidosis is a common complication in chronic kidney disease (CKD) patients, and is associated with an accelerated decline in renal function. Oral bicarbonate therapy has been used to counteract metabolic acidosis in CKD for decades. However, until recently, there have been very few intervention studies testing the effectiveness of bicarbonate therapy at improving metabolic acidosis or its consequences in patients with CKD. In this systematic review and meta-analysis, we aimed to examine the outcomes of all published randomised controlled trials (RCTs) that investigated the effect of oral bicarbonate therapy in adults with CKD. Ovid MEDLINE®, EMBASE® and Cochrane Library were searched in mid-October 2018 for English literature, with no restrictions applied to the publication status or date. Seven RCTs that recruited 815 participants met our inclusion criteria after full text review. Oral bicarbonate supplementation resulted in a slightly higher estimated glomerular filtration rate (eGFR) (mean difference 3.1 mL/min per 1.73 m2; 95% CI 1.3–4.9) and serum bicarbonate levels (mean difference 3.4 mmol/L; 95% CI 1.9–4.9) at the end of follow-up (three months to five years) compared to those given placebo or conventional CKD treatment. When limited to studies reporting outcomes at one year, the positive effect of oral bicarbonate therapy on eGFR was attenuated. There were no significant treatment effects in other parameters such as systolic blood pressure (BP) and weight. These findings should be interpreted with caution and further trial evidence is needed to establish the net overall benefit or harm of oral bicarbonate therapy in CKD.

scholarly journals Definitions of blinding in randomised controlled trials of interventions published in high-impact anaesthesiology journals: a methodological study and survey of authors

BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e035168 ◽  
Author(s):  
Antonija Penić ◽  
Dinka Begić ◽  
Karolina Balajić ◽  
Martin Kowalski ◽  
Ana Marušić ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Methodological Study ◽  
Cross Sectional Survey ◽  
Open Label ◽  
Double Blind ◽  
Cross Sectional ◽  
The Status ◽  
Peer Reviewers ◽  
Randomised Controlled

ObjectivesTo analyse the completeness of reporting of blinding in randomised controlled trials (RCTs) of interventions in anaesthesiology, the actual blinding status of various persons associated with an RCT and trial authors’ interpretation of blinding terminology related to RCTs.MethodsThis was a methodological study and a cross-sectional survey. We analysed reporting related to blinding in published RCTs of interventions published in seven highly cited anaesthesiology journals from 2014 to 2016 and registered protocols in ClinicalTrials.gov. We surveyed corresponding authors of included RCTs about their definitions of blinding. The primary outcome was the number of RCTs that explicitly described who was blinded in a trial. Secondary outcomes were definitions of blinding terminology in the trials; trial authors’ interpretation of blinding terminology; discrepancies in the blinding description within registered protocols and between registered protocols and publications.ResultsOut of 622 analysed RCTs, 38% were not explicitly described as either open label or blinded studies and 10% did not report any information about blinding or lack of blinding. Only one manuscript fully reported the status of blinding for various individuals that may be involved with a trial. The most common descriptor was that a trial was double-blind. We found discrepant information regarding blinding in the majority of registered protocols. Even when there were no discrepancies in the registration, we found discrepancies in the reporting of blinding between the majority of registered protocols and published manuscripts. The survey of authors (40 responses from 231 eligible authors; 17% response rate) of analysed RCTs showed that they differed in how they defined different levels of blinding in trials.ConclusionsReporting of the blinding status of key individuals involved in analysed anaesthesiology RCTs was insufficient. For reporting guidelines, peer reviewers and editors should insist on clear information on who was blinded in a trial instead of using the term ‘double-blind’ for different blinding practices.

scholarly journals The Stanley Foundation Bipolar Network

2001 ◽  
Vol 178 (S41) ◽  
pp. s169-s176 ◽  
Author(s):  
Robert M. Post ◽  
Kirk D. Denicoff ◽  
Gabriele S. Leverich ◽  
Willem A. Nolen ◽  
Ralph W. Kupka ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Clinical Case ◽  
Case Series ◽  
Controlled Trials ◽  
Omega 3 Fatty Acids ◽  
Omega 3 ◽  
Double Blind ◽  
Bipolar Illness ◽  
Randomised Controlled

BackgroundThe Stanley Foundation Bipolar Network (SFBN) was created to address the paucity of help studies in bipolar illness.AimsTo describe the rationale and methods of the SFBN.MethodThe SFBN includes five core sites and a number of affiliated sites that have adopted consistent methodology for continuous longitudinal monitoring of patients. Open and controlled studies are performed as patients' symptomatology dictates.ResultsThe reliability of SFBN raters and the validity of the rating instruments have been established. More than 500 patients are in continuous daily longitudinal follow-up. More than 125 have been randomised to one of three of the newer antidepressants (bupropion, sertraline and venlafaxine) as adjuncts in a study of mood stabilisers and 93 to omega-3 fatty acids. A number of open clinical case series have been published.ConclusionsWell-characterised patients are followed in a detailed continuous longitudinal fashion in both opportunistic case series and double-blind, randomised controlled trials with reliable and validated measures.

scholarly journals Evaluating agreement between bodies of evidence from randomised controlled trials and cohort studies in nutrition research: meta-epidemiological study

BMJ ◽  
2021 ◽  
pp. n1864
Author(s):  
Lukas Schwingshackl ◽  
Sara Balduzzi ◽  
Jessica Beyerbach ◽  
Nils Bröckelmann ◽  
Sarah S Werner ◽  
...  
Keyword(s):  
Cohort Studies ◽  
Randomised Controlled Trials ◽  
Prediction Interval ◽  
Prediction Intervals ◽  
Controlled Trials ◽  
Nutrition Research ◽  
The Difference ◽  
Bodies Of Evidence ◽  
Randomised Controlled ◽  
Risk Ratios

Abstract Objective To evaluate the agreement between diet-disease effect estimates of bodies of evidence from randomised controlled trials and those from cohort studies in nutrition research, and to investigate potential factors for disagreement. Design Meta-epidemiological study. Data sources Cochrane Database of Systematic Reviews, and Medline. Review methods Population, intervention or exposure, comparator, outcome (PI/ECO) elements from a body of evidence from cohort studies (BoE(CS)) were matched with corresponding elements of a body of evidence from randomised controlled trials (BoE(RCT)). Pooled ratio of risk ratios or difference of mean differences across all diet-disease outcome pairs were calculated. Subgroup analyses were conducted to explore factors for disagreement. Heterogeneity was assessed through I 2 and τ 2 . Prediction intervals were calculated to assess the range of possible values for the difference in the results between evidence from randomised controlled trials and evidence from cohort studies in future comparisons. Results 97 diet-disease outcome pairs (that is, matched BoE(RCT) and BoE(CS)) were identified overall. For binary outcomes, the pooled ratio of risk ratios comparing estimates from BoE(RCT) with BoE(CS) was 1.09 (95% confidence interval 1.04 to 1.14; I 2 =68%; τ 2 =0.021; 95% prediction interval 0.81 to 1.46). The prediction interval indicated that the difference could be much more substantial, in either direction. We further explored heterogeneity and found that PI/ECO dissimilarities, especially for the comparisons of dietary supplements in randomised controlled trials and nutrient status in cohort studies, explained most of the differences. When the type of intake or exposure between both types of evidence was identical, the estimates were similar. For continuous outcomes, small differences were observed between randomised controlled trials and cohort studies. Conclusion On average, the difference in pooled results between estimates from BoE(RCT) and BoE(CS) was small. But wide prediction intervals and some substantial statistical heterogeneity in cohort studies indicate that important differences or potential bias in individual comparisons or studies cannot be excluded. Observed differences were mainly driven by dissimilarities in population, intervention or exposure, comparator, and outcome. These findings could help researchers further understand the integration of such evidence into prospective nutrition evidence syntheses and improve evidence based dietary guidelines.

scholarly journals Efficacy of onabotulinumtoxinA in the treatment of unipolar major depression: Systematic review, meta-analysis and meta-regression analyses of double-blind randomised controlled trials

2021 ◽  
pp. 026988112199182
Author(s):  
Danilo Arnone ◽  
Hassan Galadari ◽  
Carl J Rodgers ◽  
Linda Östlundh ◽  
Karim Abdel Aziz ◽  
...  
Keyword(s):  
Major Depression ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Regression Analyses ◽  
Double Blind ◽  
Pharmacological Interactions ◽  
Meta Regression ◽  
Randomised Controlled ◽  
Meta Analyses

Background: OnabotulinumtoxinA is a novel therapeutic intervention whose mechanism of action is believed to modify the negative facial feedback, thus abating symptoms of depression. This putative new antidepressant agent offers minimal systemic side effects and negligible risk of pharmacological interactions. We set out to examine the evidence for the use of onabotulinumtoxinA in major depression. Methods: A systematic search of the literature identified double-blind randomised controlled trials (RCTs) investigating the use of onabotulinumtoxinA in the treatment of major depression versus placebo. Data, reported according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA), was combined in meta-analyses (PROSPERO registration ID: CRD42020183538). Results: The search identified five RCTs (four double-blind) comparing onabotulinumtoxinA to placebo. OnabotulinumtoxinA was more effective than placebo when administered within the 20–40 IU dose range in double-blind RCTs. The analysis was free of publication bias and significantly heterogeneous. Meta-regression analyses indicated that onabotulinumtoxinA was more efficacious in women and in higher doses in female patients and less effective with polypharmacy, especially when an increasing number of antidepressants were prescribed. The effectiveness of onabotulinumtoxinA was higher in more recently published double-blind RCTs. Conclusion: The meta-analysis supports the efficacy of the intervention with the results being highly heterogeneous across studies. In view of the heterogeneity of the findings and the significant moderators of benefit (sex, year of study completion and the interaction between sex and dose), more research is required to better understand the role of onabotulinumtoxinA in the treatment of depression.

Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials

The Lancet ◽  
2006 ◽  
Vol 368 (9539) ◽  
pp. 929-937 ◽  
Author(s):  
Jon L Pryor ◽  
Stanley E Althof ◽  
Christopher Steidle ◽  
Raymond C Rosen ◽  
Wayne JG Hellstrom ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Premature Ejaculation ◽  
Integrated Analysis ◽  
Controlled Trials ◽  
Double Blind ◽  
Randomised Controlled
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