scholarly journals The effects of a novel bicarbonate loading protocol on serum bicarbonate concentration: a randomized controlled trial

2019 ◽  
Vol 16 (1) ◽  
Author(s):  
Adam Marcus ◽  
Amerigo Rossi ◽  
Andrew Cornwell ◽  
Steven A. Hawkins ◽  
Nazareth Khodiguian
Keyword(s):  
Sodium Bicarbonate ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Elevated Serum ◽  
Self Report ◽  
Serum Bicarbonate ◽  
Bicarbonate Concentration ◽  
Link Type ◽  
Men 2 ◽  
Gastrointestinal Distress

Abstract Background Previous studies have shown that sodium bicarbonate ingestion may enhance intense exercise performance, but may also cause severe gastrointestinal distress. The purpose of this study was to determine whether a modified sodium bicarbonate (SB) ingestion protocol would elevate serum bicarbonate concentration more than previous methods without causing gastrointestinal distress. Methods In randomized order, seven (5 men, 2 women) elite middle-distance runners ingested either placebo, Modified SB (600 mg·kg− 1 over 19.5 h), or Acute SB (300 mg·kg− 1) in opaque gelatin capsules. Baseline and post-ingestion blood samples were analyzed for bicarbonate, pH, sodium, hematocrit, and lactate. Repeated measures ANOVA (2 time points × 3 conditions) were analyzed to determine differences in serum bicarbonate, lactate, sodium, blood pH, and hematocrit. Gastrointestinal distress was assessed via self-report on a Likert scale of 1–10. Simple (condition) and repeated (time) within-participant contrasts were used to determine the location of any statistically significant main and interaction effects (p ≤ 0.05). Results Both Modified SB (7.6 mmol·L− 1, p < 0.01) and Acute SB (5.8 mmol·L− 1, p < 0.01) increased serum bicarbonate concentration compared to the placebo (p ≤ 0.05). Post-ingestion serum bicarbonate concentration was significantly higher for the Modified SB (34.7 ± 2.2 mmol·L− 1, 28.0% increase) trials than the Acute SB (33.5 ± 2.0 mmol·L− 1, 20.9% increase) trials (p = 0.05). There was no reported severe GI distress in the Modified SB trials, but two cases in the Acute SB trials. Conclusions Modified SB elevated serum bicarbonate concentration more than Acute SB, without any severe gastrointestinal side effects. Consequently, it is recommended that future experimentation involving SB by researchers and athletes use the novel ingestion protocol described in this study due to its potential for improved effectiveness and reduced gastrointestinal impact. Trial registration ClinicalTrials.gov ,NCT03813329. Registered 23 January 2019 - Retrospectively registered,

scholarly journals Effectiveness of a hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burn injuries: a prospective randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e039981
Author(s):  
Maleea Denise Holbert ◽  
Roy M Kimble ◽  
Mark Chatfield ◽  
Bronwyn R Griffin
Keyword(s):  
Randomised Controlled Trial ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Geometric Mean ◽  
First Aid ◽  
Self Report ◽  
Thermal Burn ◽  
Pain Scores ◽  
Registration Number ◽  
Randomised Controlled

ObjectiveTo compare the effectiveness of two acute burn dressings, Burnaid hydrogel dressing and plasticised polyvinylchloride film, on reducing acute pain scores in paediatric burn patients following appropriate first aid.DesignSingle-centre, superiority, two-arm, parallel-group, prospective randomised controlled trial.Participants and settingPaediatric patients (aged ≤16) presenting to the Emergency Department at the Queensland Children’s Hospital, Brisbane, Australia, with an acute thermal burn were approached for participation in the trial from September 2017–September 2018.InterventionsPatients were randomised to receive either (1) Burnaid hydrogel dressing (intervention) or (2) plasticised polyvinylchloride film (Control) as an acute burn dressing.Primary and secondary outcomesObservational pain scores from nursing staff assessed 5 min post application of the randomised dressing, measured using the Face Legs Activity Cry and Consolability Scale was the primary outcome. Repeated measures of pain, stress and re-epithelialisation were also collected at follow-up dressing changes until 95% wound re-epithelialisation occurred.ResultsSeventy-two children were recruited and randomised (n=37 intervention; n=35 control). No significant between-group differences in nursing (mean difference: −0.1, 95% CI −0.7 to 0.5, p=0.72) or caregiver (MD: 1, 95% CI −8 to 11, p=0.78) observational pain scores were identified. Moreover, no significant differences in child self-report pain (MD: 0.3, 95% CI −1.7 to 2.2, p=0.78), heart rate (MD: −3, 95% CI −11 to 5, p=0.41), temperature (MD: 0.6, 95% CI −0.13 to 0.24, p=0.53), stress (geometric mean ratio: 1.53, 95% CI 0.93 to 2.53, p=0.10), or re-epithelialisation rates (MD: −1, 95% CI −3 to 1, p=0.26) were identified between the two groups.ConclusionsA clear benefit of Burnaid hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burns was not identified in this investigation.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12617001274369).

Effectiveness of Triamcinolone Hexacetonide Intraarticular Injection in Interphalangeal Joints: A 12-week Randomized Controlled Trial in Patients with Hand Osteoarthritis

2015 ◽  
Vol 42 (10) ◽  
pp. 1869-1877 ◽  
Author(s):  
Natalia de Oliva Spolidoro Paschoal ◽  
Jamil Natour ◽  
Flavia S. Machado ◽  
Hilda Alcântara Veiga de Oliveira ◽  
Rita Nely Vilar Furtado
Keyword(s):  
Adverse Effects ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Hand Function ◽  
Intraarticular Injection ◽  
Pinch Strength ◽  
Hand Osteoarthritis ◽  
Triamcinolone Hexacetonide ◽  
Link Type ◽  
Pain At Rest

Objective.To evaluate the effectiveness and tolerance of intraarticular injection (IAI) of triamcinolone hexacetonide (TH) for the treatment of osteoarthritis (OA) of hand interphalangeal (IP) joints.Methods.Sixty patients who underwent IAI at the most symptomatic IP joint were randomly assigned to receive TH/lidocaine (LD; n = 30) with TH 20 mg/ml and LD 2%, or just LD (n = 30). The injected joint was immobilized with a splint for 48 h in both groups. Patients were assessed at baseline and at 1, 4, 8, and 12 weeks by a blinded observer. The following variables were assessed: pain at rest [visual analog scale (VAS)r], pain at movement (VASm), swelling (physician VASs), goniometry, grip and pinch strength, hand function, treatment improvement, daily requirement of paracetamol, and local adverse effects. The proposed treatment (IAI with TH/LD) was successful if statistical improvement (p < 0.05) was achieved in at least 2 of 3 VAS. Repeated-measures ANOVA test was used to analyze intervention response.Results.Fifty-eight patients (96.67%) were women, and the mean age was 60.7 years (± 8.2). The TH/LD group showed greater improvement than the LD group for VASm (p = 0.014) and physician VASs (p = 0.022) from the first week until the end of the study. In other variables, there was no statistical difference between groups. No significant adverse effects were observed.Conclusion.The IAI with TH/LD has been shown to be more effective than the IAI with LD for pain on movement and joint swelling in patients with OA of the IP joints. Regarding pain at rest, there was no difference between groups. Trial registration number: ClinicalTrials.gov (NCT02102620).

scholarly journals Serum Bicarbonate Concentration and Cognitive Function in Hypertensive Adults

2018 ◽  
Vol 13 (4) ◽  
pp. 596-603 ◽  
Author(s):  
Mirela Dobre ◽  
Sarah A. Gaussoin ◽  
Jeffrey T. Bates ◽  
Michel B. Chonchol ◽  
Debbie L. Cohen ◽  
...  
Keyword(s):  
Magnetic Resonance Imaging ◽  
Executive Function ◽  
Metabolic Acidosis ◽  
Cognitive Function ◽  
Magnetic Resonance ◽  
Bicarbonate Level ◽  
Serum Bicarbonate ◽  
Resonance Imaging ◽  
Bicarbonate Concentration ◽  
Link Type

Background and objectivesCognitive function worsens as kidney function declines, but mechanisms contributing to this association are not completely understood. Metabolic acidosis, a common complication of CKD, leads to neural networks overexcitation and is involved in cerebral autoregulation. We aimed to evaluate the association between serum bicarbonate concentration as a measure of metabolic acidosis, and cognitive function in hypertensive adults with and without CKD.Design, setting, participants, & measurementsFive cognitive summary scores were measured (global cognitive function, executive function, memory, attention/concentration, and language) in 2853 participants in the Systolic BP Intervention Trial (SPRINT). Multivariable linear regression models adjusted for demographics, comorbidities, systolic BP, medications, eGFR and albuminuria evaluated the cross-sectional association between bicarbonate and cognition at SPRINT baseline. In a subset (n=681) who underwent brain magnetic resonance imaging, the models were adjusted for white matter hyperintensity volume, vascular reactivity, and cerebral blood flow.ResultsThe mean age (SD) was 68 (8.5) years. Global cognitive and executive functions were positively associated with serum bicarbonate (estimate [SEM]: 0.014 [0.006]; P=0.01, and 0.018 [0.006]; P=0.003, respectively). Each 1 mEq/L lower bicarbonate level had a similar association with global cognitive and executive function as being 4.3 and 5.4 months older, respectively. The association with global cognition persisted after magnetic resonance imaging findings adjustment (estimate [SEM]: 0.03 [0.01]; P=0.01). There was no association between serum bicarbonate level and memory, attention/concentration, and language.ConclusionsIn a large cohort of hypertensive adults, higher serum bicarbonate levels were independently associated with better global cognitive and executive performance. (ClinicalTrials.gov: NCT01206062).

scholarly journals 1105 A Randomized Controlled Trial of a Psychological Intervention for Decreasing Bedtime Procrastination: The BED-PRO Study

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A420-A420
Author(s):  
S Suh† ◽  
G Kim ◽  
S Jeoung ◽  
H An
Keyword(s):  
Negative Affect ◽  
Behavioral Intervention ◽  
Repeated Measures ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Self Report ◽  
Sleep Diary ◽  
Control Group ◽  
Ctrl Group ◽  
Bedtime Procrastination

Abstract Introduction Bedtime Procrastination (BP) is defined as the behavior of going to bed later than intended, without having external reasons for doing so. Previous studies have shown that BP has a negative effect on sleep and health, and there is a need to develop interventions to decrease BP. This study (BED-PRO) is an ongoing study evaluating a behavioral intervention to reduce BP. Methods Fifteen participants who scored higher than 33 on the Bedtime Procrastination Scale were randomized to either the treatment (TRT, n=6) or control group (CTRL, n=9). Treatment consisted of four face-to-face individual sessions. All participants completed self-report questionnaires on Bedtime Procrastination Scale (BPS), Epworth Sleepiness Scale (ESS), Positive Affect and Negative Affect Schedule (K-PANAS-R) and completed the 7-day sleep diary. Data was analyzed using two-way mixed Measures Analysis of Variance (ANOVA). Results Mean age of the participants was 21.78 (±1.8) years and 80% (n=12) were females. Group by time interactions from repeated measures analyses revealed significant post intervention improvements in the TRT group compared to the CTRL group on all bedtime procrastination duration and scores, sleep efficiency, refreshment after waking, daytime sleepiness and negative affect of K-PANAS-R. Specifically, bedtime procrastination duration in the TRT group measured by sleep diaries decreased significantly from 75.30 (±58.57) min to 14.83 (±7.83) min, while the CTRL group did not change from 57.60 (±32.01) to 54.36 (±40.82) min (p=0.019). In addition, the TRT group reported significant improvements in bedtime procrastination scores from 36.00 (±4.05) to 22.50 (±6.72). Conclusion Based on results, the behavioral intervention used in this study looks promising in improving bedtime procrastination and sleep. Support This work was supported by the Ministry of Education of the Republic of Korea and the National Research Foundation of Korea(NRF-2018S1A5A8026807)

scholarly journals Educational films for improving screening and self-management of gestational diabetes in India and Uganda (GUIDES): study protocol for a cluster-randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Laura L. Oakley ◽  
Deepa R ◽  
Arthur Namara ◽  
Biswamitra Sahu ◽  
Iliatha Papachristou Nadal ◽  
...  
Keyword(s):  
Gestational Diabetes ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Self Report ◽  
Self Management ◽  
Secondary Outcome ◽  
Behavioural Intervention ◽  
Link Type ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background The prevalence of gestational diabetes mellitus (GDM) is rising rapidly in many low- and middle-income countries (LMICs). Most women with GDM in LMICs are undiagnosed and/or inadequately managed due to a lack of knowledge and skills about GDM on the part of both providers and patients. Following contextual analysis, we developed an educational/behavioural intervention for GDM delivered through a package of culturally tailored films. This trial aims to evaluate whether the intervention can improve the timely detection and management of GDM in two LMIC settings. Methods Two independent cluster randomised controlled trials, one each to be conducted in Uganda and India. Thirty maternity facilities in each country have been recruited to the study and randomised in a 1:1 ratio to the intervention and control arms. The intervention comprises of three interconnected sets of films with the following aims: to improve knowledge of GDM guidelines and skills of health providers, to raise awareness of GDM screening among pregnant women and their families, and to improve confidence and skills in self-management among those diagnosed with GDM. In facilities randomised to the intervention arm, a GDM awareness-raising film will be shown in antenatal care waiting rooms, and four films for pregnant women with GDM will be shown in group settings and made available for viewing on mobile devices. Short films for doctors and nurses will be presented at professional development meetings. Data will be collected on approximately 10,000 pregnant women receiving care at participating facilities, with follow-up at 32 weeks gestational age and 6 weeks postnatally. Women who self-report a GDM diagnosis will be invited for a clinic visit at 34 weeks. Primary outcomes are (a) the proportion of women who report a GDM diagnosis by 32 weeks of pregnancy and (b) glycaemic control (fasting glucose and HbA1C) in women with GDM at ~34 weeks of pregnancy. The secondary outcome is a composite measure of GDM-related adverse perinatal-neonatal outcome. Discussion Screening and management of GDM are suboptimal in most LMICs. We hypothesise that a scalable film-based intervention has the potential to improve the timely detection and management of GDM in varied LMIC settings. Trial registration ClinicalTrials.gov NCT03937050, registered on 3 May 2019. Clinical Trials Registry India CTRI/2020/02/023605, registered on 26 February 2020.

scholarly journals A Virtual Reality based intervention for surgical patients: study protocol of a randomized controlled trial

2020 ◽  
Author(s):  
Raluca Georgescu ◽  
Anca Dobrean ◽  
Cristina Alina Silaghi ◽  
Horațiu Silaghi
Keyword(s):  
Randomized Controlled Trial ◽  
Virtual Reality ◽  
Repeated Measures ◽  
Standard Treatment ◽  
Controlled Trial ◽  
Self Report ◽  
Control Group ◽  
Randomized Controlled ◽  
Pain Outcomes ◽  
Before And After

Abstract Background: Pain after surgery is normal, and treatments, including both pharmacological and psychological components, are fundamental for proper postoperative care. While several trials have investigated the analgesic effect of traditional non-pharmacological treatments, such as Cognitive Behaviors Therapies, the newer ways of delivering psychological interventions for pain after surgery are scarcely investigated. The aim of this randomized controlled trial (RCT) is to determine if delivering the psychological content through Virtual Reality (VR) along with the standard pharmacological treatment return better pain relief outcomes than standard care in adult patients following surgery. Methods: This is a protocol of a parallel RCT conducted in one community hospital. In order to test the efficacy of VR environments for reducing pain intensity, in the following day after surgery, adults (18 to 65 years) will be randomly assigned to either (1) standard treatment after surgery (control group) or (2) VR based intervention along with standard treatment. It is intended that a minimum of 30 patients be recruited in each group. For estimating the intensity of pain, both self-report and physiological measures will be used. Repeated measures of pain outcomes will be taken before and after the intervention. Moreover, for allowing an in-depth investigation of the effect of VR environments, the primary outcome will be complemented with measures of the adverse effects, level of immersion, and level of presence in the VR environment.

scholarly journals Ixekizumab improves sleep and work productivity in patients with non-radiographic axial spondyloarthritis: results from the COAST-X trial at 52 weeks

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Atul Deodhar ◽  
Philip Mease ◽  
Helena Marzo-Ortega ◽  
Theresa Hunter ◽  
David Sandoval ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Axial Spondyloarthritis ◽  
Controlled Trial ◽  
Work Productivity ◽  
Analysis Of Covariance ◽  
Activity Impairment ◽  
Work Activity ◽  
Work Impairment ◽  
Link Type ◽  
Dosing Regimens

Abstract Background Patients with non-radiographic axial spondyloarthritis experience negative impacts on sleep, work productivity, and activity impairment. Ixekizumab, a monoclonal antibody selectively targeting interleukin-17A, has shown efficacy in treating the signs and symptoms of non-radiographic axial spondyloarthritis. This analysis evaluated the effect of ixekizumab treatment on sleep, work productivity, and activity impairment in patients with non-radiographic axial spondyloarthritis. Methods COAST-X (NCT02757352) was a 52-week, phase 3, multicenter, randomised placebo-controlled trial evaluating 80-mg ixekizumab every 2 weeks and every 4 weeks in patients with active non-radiographic axial spondyloarthritis. Sleep disturbance was measured with the Jenkins Sleep Evaluation Questionnaire (JSEQ) and analysed using mixed-effects models for repeated measures. Work productivity and activity impairment were measured using the Work Productivity and Activity Impairment Questionnaire for Spondyloarthritis and analysed using analysis of covariance. Absenteeism, presenteeism, and overall work impairment were assessed for patients reporting paid work; activity impairment was assessed regardless of work status. Results Overall, patients treated with both dosing regimens of ixekizumab reported numerically greater improvements in sleep than placebo through Week 52. At Weeks 16 and 52, patients treated with ixekizumab every 4 weeks had significantly greater improvements in presenteeism (p = 0.007 and p = 0.003, respectively) and overall work impairment (p = 0.014 and p = 0.005, respectively) and numeric improvements in absenteeism than placebo. Patients treated with ixekizumab every 2 weeks had numerically greater improvements in absenteeism, presenteeism, and overall work impairment than placebo. Both dosing regimens of ixekizumab were associated with significantly greater improvements in activity impairment than placebo (ixekizumab every 4 weeks: p = 0.003 at Week 16 and p = 0.004 at Week 52; ixekizumab every 2 weeks: p = 0.007 at Week 16 and p = 0.006 at Week 52). Conclusions Treatment with ixekizumab improved sleep, work productivity, and activity impairment in patients with nr-axSpA. Improvements in presenteeism and overall work impairment were sustained and consistent in the patients treated with ixekizumab every 4 weeks from Week 16 to Week 52. Improvements in activity impairment were sustained and consistent in both ixekizumab-treated groups from Week 16 to Week 52. Trial registration NCT02757352, May 2, 2016.

scholarly journals A Virtual Reality based intervention for surgical patients: study protocol of a randomized controlled trial

2021 ◽  
Author(s):  
Raluca Georgescu ◽  
Anca Dobrean ◽  
Cristina Alina Silaghi ◽  
Horațiu Silaghi
Keyword(s):  
Randomized Controlled Trial ◽  
Virtual Reality ◽  
Repeated Measures ◽  
Standard Treatment ◽  
Controlled Trial ◽  
Self Report ◽  
Control Group ◽  
Randomized Controlled ◽  
Pain Outcomes ◽  
Before And After

Abstract Background: Pain after surgery is normal, and treatments, including both pharmacological and psychological components, are fundamental for proper postoperative care. While several trials have investigated the analgesic effect of traditional non-pharmacological treatments, such as Cognitive Behaviors Therapies, the newer ways of delivering psychological interventions for pain after surgery are scarcely investigated. The aim of this randomized controlled trial (RCT) is to determine if delivering the psychological content through Virtual Reality (VR) along with the standard pharmacological treatment return better pain relief outcomes than standard care in adult patients following surgery. Methods: This is a protocol of a parallel RCT conducted in one community hospital. In order to test the efficacy of VR environments for reducing pain intensity, in the following day after surgery, adults (18 to 65 years) will be randomly assigned to either (1) standard treatment after surgery (control group) or (2) VR based intervention along with standard treatment. It is intended that a minimum of 30 patients be recruited in each group. For estimating the intensity of pain, both self-report and physiological measures will be used. Repeated measures of pain outcomes will be taken before and after the intervention. Moreover, for allowing an in-depth investigation of the effect of VR environments, the primary outcome will be complemented with measures of the adverse effects, level of immersion, and level of presence in the VR environment. Trial registration ClinicalTrials.gov, NCT03776344. Registered on December 14, 2018.

scholarly journals Oral sodium bicarbonate in people on haemodialysis: a randomised controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Stella I. Kourtellidou ◽  
Damien R. Ashby ◽  
Lina R. Johansson
Keyword(s):  
Sodium Bicarbonate ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Serum Bicarbonate ◽  
Lean Tissue ◽  
Tissue Mass ◽  
Lean Tissue Mass ◽  
Randomised Controlled ◽  
Oral Sodium

Abstract Background Adverse events and mortality tend to cluster around dialysis sessions, potentially due to the impact of the saw-toothed profile of uraemic toxins such as potassium, peaking pre-dialysis and rapidly dropping during dialysis. Acidosis could be contributing to this harm by exacerbating a rise in potassium. The objectives of this study were to investigate the effects of oral bicarbonate treatment on reducing inter-dialytic potassium gain as well as other clinical consequences of preserving muscle mass and function and reducing intradialytic arrhythmia risk in people on haemodialysis. Methods Open-label randomised controlled trial in a single-centre (London, UK). Forty-three clinically stable adults on haemodialysis were recruited, with a 6 month average pre-dialysis serum bicarbonate level < 22 mmol/l and potassium > 4 mmol/l. Thirty-three participants completed the study. Oral sodium bicarbonate tablets titrated up to a maximum of 3 g bd (6 g total) in intervention group for 12 weeks versus no treatment in the control group. Outcomes compared intervention versus non-intervention phases in the treated group and equivalent time points in the control group: pre- and post-dialysis serum potassium; nutritional assessments: muscle mass and handgrip strength and electrocardiograms (ECGs) pre and post dialysis. Results Participants took an average of 3.7 ± 0.5 g sodium bicarbonate a day. In the intervention group, inter-dialytic potassium gain was reduced from 1.90 ± 0.60 to 1.69 ± 0.49 mmol/l (p = 0.032) and pre-dialysis potassium was reduced from 4.96 ± 0.62 to 4.79 ± 0.49 mmol/l without dietary change. Pre-dialysis bicarbonate increased from 18.15 ± 1.35 to 20.27 ± 1.88 mmol/l, however with an increase in blood pressure. Nutritionally, lean tissue mass was reduced in the controls suggesting less catabolism in the intervention group. There was no change in ECGs. Limitations are small sample size and unblinded study design lacking a placebo, with several participants failing to achieve the target of 22 mmol/l serum bicarbonate levels due mainly to tablet burden. Conclusion Oral sodium bicarbonate reduced bicarbonate loss and potassium gain in the inter-dialytic period, and may also preserve lean tissue mass. Trial registration The study was registered prospectively on 06/08/2015 with EU Clinical Trials Register EudraCT number 2015-001439-20.

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