scholarly journals Hypotension in Preterm Infants (HIP) randomised trial

2021 ◽  
pp. fetalneonatal-2020-320241
Author(s):  
Eugene M Dempsey ◽  
Keith J Barrington ◽  
Neil Marlow ◽  
Colm Patrick Finbarr O'Donnell ◽  
Jan Miletin ◽  
...  
Keyword(s):  
Brain Injury ◽  
Primary Outcome ◽  
Randomised Trial ◽  
Intraventricular Haemorrhage ◽  
Standard Group ◽  
Double Blind ◽  
Group Assignment ◽  
Standard Management ◽  
Postmenstrual Age ◽  
Registration Number

ObjectiveTo determine whether restricting the use of inotrope after diagnosis of low blood pressure (BP) in the first 72 hours of life affects survival without significant brain injury at 36 weeks of postmenstrual age (PMA) in infants born before 28 weeks of gestation.DesignDouble-blind, placebo-controlled randomised trial. Caregivers were masked to group assignment.Setting10 sites across Europe and Canada.ParticipantsInfants born before 28 weeks of gestation were eligible if they had an invasive mean BP less than their gestational age that persisted for ≥15 min in the first 72 hours of life and a cerebral ultrasound free of significant (≥ grade 3) intraventricular haemorrhage.InterventionParticipants were randomly assigned to saline bolus followed by either a dopamine infusion (standard management) or placebo (5% dextrose) infusion (restrictive management).Primary outcomeSurvival to 36 weeks of PMA without severe brain injury.ResultsThe trial terminated early due to significant enrolment issues (7.7% of planned recruitment). 58 infants were enrolled between February 2015 and September 2017. The two groups were well matched for baseline variables. In the standard group, 18/29 (62%) achieved the primary outcome compared with 20/29 (69%) in the restrictive group (p=0.58). Additional treatments for low BP were used less frequently in the standard arm (11/29 (38%) vs 19/29 (66%), p=0.038).ConclusionThough this study lacked power, we did not detect major differences in clinical outcomes between standard or restrictive approach to treatment. These results will inform future studies in this area.Trial registration numberNCT01482559, EudraCT 2010-023988-17.

Comparison of the effectiveness of circumferential versus non-circumferential spread in median and ulnar nerve blocks. A double-blind randomized clinical trial

2020 ◽  
Vol 45 (5) ◽  
pp. 362-366
Author(s):  
Paula Dieguez-Garcia ◽  
Servando Lopez-Alvarez ◽  
Jorge Juncal ◽  
Ana M Lopez ◽  
Xavier Sala-Blanch
Keyword(s):  
Median Nerve ◽  
Ulnar Nerve ◽  
Motor Block ◽  
Primary Outcome ◽  
Sensory Block ◽  
Nerve Blocks ◽  
Double Blind ◽  
Registration Number ◽  
Tunnel Syndrome ◽  
To Receive

Background and objectivesCircumferential (C) spread of local anesthetic around the nerve is recommended for a successful nerve block. We tested the hypothesis that C spread produces a more complete block than non-circumferential (NC) spread.MethodsWe randomized 124 patients undergoing open carpal tunnel syndrome surgery to receive C or NC spread ultrasound-guided median and ulnar nerve blocks. The primary outcome was the proportion of patients who developed complete sensory block measured at 5, 15 and 30 min. The loss of cold sensation was graded as: 0 (complete block), 1 (incomplete block), or 2 (no block). Secondary outcomes included motor block, nerve swelling and adverse events.ResultsIn group C, complete sensory block at 5 min was 2.4 (95% CI 1.0 to 5.7; p=0.04) times more frequent in the median nerve and 3.0 (95% CI 1.2 to 7.2; p=0.01) times more frequent in the ulnar nerve compared with group C. However, at 15 and 30 min, it was similar between groups. Complete motor block was more frequent in group C than in group NC for both the median nerve: 1.5 (95% CI 1.1 to 2.2; p<0.01) at 15 min, 1.1 (95% CI 1.0 to 1.2; p=0.02) at 30 min, and the ulnar nerve: 1.7 (95% CI 1.2 to 2.6; p<0.01) at 15 min, 1.2 (95% CI 1.0 to 1.4; p<0.01) at 30 min. The incidence of nerve swelling and adverse effects was similar between groups.ConclusionsC spread around the median and ulnar nerves at the level of the antecubital fossa generates more complete sensory and motor blocks compared with NC spread.Trial registration numberEudraCT 2011-002608-34 and NCT01603680

scholarly journals When Basic Research Doesn't Translate to the Bedside—Lessons from the Magnesium Brain Trauma Study

2007 ◽  
Vol 7 (5) ◽  
pp. 133-135 ◽  
Author(s):  
John W. Miller ◽  
Raimondo D'Ambrosio
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Severe Traumatic Brain Injury ◽  
Primary Outcome ◽  
Brain Injuries ◽  
Controlled Trial ◽  
Serum Magnesium ◽  
Trauma Centre ◽  
Double Blind ◽  
Positive Effect

Magnesium Sulfate for Neuroprotection After Traumatic Brain Injury: A Randomised Controlled Trial. Temkin NR, Anderson GD, Winn HR, Ellenbogen RG, Britz GW, Schuster J, Lucas T, Newell DW, Mansfield PN, Machamer JE, Barber J, Dikmen SS. Lancet Neurol 2007;6(1):29–38. BACKGROUND: Traumatic brain injuries represent an important and costly health problem. Supplemental magnesium positively affects many of the processes involved in secondary injury after traumatic brain injury and consistently improves outcome in animal models. We aimed to test whether treatment with magnesium favourably affects outcome in head-injured patients. METHODS: In a double-blind trial, 499 patients aged 14 years or older admitted to a level 1 regional trauma centre between August, 1998, and October, 2004, with moderate or severe traumatic brain injury were randomly assigned one of two doses of magnesium or placebo within 8 h of injury and continuing for 5 days. Magnesium doses were targeted to achieve serum magnesium ranges of 1 0–1·85 mmol/L or 1·25–2·5 mmol/L. The primary outcome was a composite of mortality, seizures, functional measures, and neuropsychological tests assessed up to 6 months after injury. Analyses were done according to the intention-to-treat principle. This trial is registered with Clinicaltrials.gov, number NCT00004730. FINDINGS: Magnesium showed no significant positive effect on the composite primary outcome measure at the higher dose (mean = 55 average percentile ranking on magnesium vs. 52 on placebo, 95% CI for difference – 7 to 14; p = 0·70). Those randomly assigned magnesium at the lower dose did significantly worse than those assigned placebo (48 vs. 54, 95% CI −10·5 to −2; p = 0007). Furthermore, there was higher mortality with the higher magnesium dose than with placebo. Other major medical complications were similar between groups, except for a slight excess of pulmonary oedema and respiratory failure in the lower magnesium target group. No subgroups were identified in which magnesium had a significantly positive effect. INTERPRETATION: Continuous infusions of magnesium for 5 days given to patients within 8 h of moderate or severe traumatic brain injury were not neuroprotective and might even have a negative effect in the treatment of significant head injury.

scholarly journals Effect of tranexamic acid on the prognosis of patients with traumatic brain injury undergoing craniotomy: study protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e049839
Author(s):  
Bei Wu ◽  
Yu Lu ◽  
Yun Yu ◽  
Hongli Yue ◽  
Jie Wang ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Tranexamic Acid ◽  
Controlled Trial ◽  
Perioperative Period ◽  
Double Blind ◽  
Ethical Approval ◽  
Registration Number ◽  
Randomised Controlled ◽  
Medical University

IntroductionAbnormal coagulation function aggravates the prognosis of patients with traumatic brain injury (TBI). It was reported that the antifibrinolytic drug tranexamic acid (TXA) could reduce intracranial haemorrhage and mortality in non-operative patients with TBI. However, there is a lack of evaluation of TXA in patients with TBI undergoing craniotomy.Methods and analysisThis is a single-centre randomised controlled, double-blind, parallel study aiming to investigate the effectiveness and safety of TXA in patients with TBI during the perioperative period. Blood loss and transfusion, neurological function, adverse events, mortality and serum immune-inflammatory cytokines will be collected and analysed.Ethics and disseminationEthical approval has been granted by the Medical Ethics Committee of Beijing Tian Tan Hospital, Capital Medical University (reference number KY 2020-136-03). The results of this study will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals.Trial registration numberChiCTR2100041911.

scholarly journals Use of proton pump inhibitors to treat persistent throat symptoms: multicentre, double blind, randomised, placebo controlled trial

BMJ ◽  
2021 ◽  
pp. m4903
Author(s):  
James O’Hara ◽  
Deborah D Stocken ◽  
Gillian C Watson ◽  
Tony Fouweather ◽  
Julian McGlashan ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Proton Pump Inhibitors ◽  
Proton Pump ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Randomised Trial ◽  
Secondary Outcome ◽  
Secondary Outcome Measure ◽  
Double Blind ◽  
Significant Difference

Abstract Objective To assess the use of proton pump inhibitors (PPIs) to treat persistent throat symptoms. Design Pragmatic, double blind, placebo controlled, randomised trial. Setting Eight ear, nose, and throat outpatient clinics, United Kingdom. Participants 346 patients aged 18 years or older with persistent throat symptoms who were randomised according to recruiting centre and baseline severity of symptoms (mild or severe): 172 to lansoprazole and 174 to placebo. Intervention Random blinded allocation (1:1) to either 30 mg lansoprazole twice daily or matched placebo twice daily for 16 weeks. Main outcome measures Primary outcome was symptomatic response at 16 weeks measured using the total reflux symptom index (RSI) score. Secondary outcomes included symptom response at 12 months, quality of life, and throat appearances. Results Of 1427 patients initially screened for eligibility, 346 were recruited. The mean age of the study sample was 52.2 (SD 13.7) years, 196 (57%) were women, and 162 (47%) had severe symptoms at presentation; these characteristics were balanced across treatment arms. The primary analysis was performed on 220 patients who completed the primary outcome measure within a window of 14-20 weeks. Mean RSI scores were similar between treatment arms at baseline: lansoprazole 22.0 (95% confidence interval 20.4 to 23.6) and placebo 21.7 (20.5 to 23.0). Improvements (reduction in RSI score) were observed in both groups—score at 16 weeks: lansoprazole 17.4 (15.5 to19.4) and placebo 15.6 (13.8 to 17.3). No statistically significant difference was found between the treatment arms: estimated difference 1.9 points (95% confidence interval −0.3 to 4.2 points; P=0.096) adjusted for site and baseline symptom severity. Lansoprazole showed no benefits over placebo for any secondary outcome measure, including RSI scores at 12 months: lansoprazole 16.0 (13.6 to 18.4) and placebo 13.6 (11.7 to 15.5): estimated difference 2.4 points (−0.6 to 5.4 points). Conclusions No evidence was found of benefit from PPI treatment in patients with persistent throat symptoms. RSI scores were similar between the lansoprazole and placebo groups after 16 weeks of treatment and at the 12 month follow-up. Trial registration ISRCTN Registry ISRCTN38578686 and EudraCT 2013-004249-17.

scholarly journals A nested randomised trial of the effect of tranexamic acid on intracranial haemorrhage and infarction in traumatic brain injury (CRASH-3 trial intracranial bleeding mechanistic study): Statistical analysis plan

2019 ◽  
Vol 3 ◽  
pp. 99
Author(s):  
Abda Mahmood ◽  
Ian Roberts ◽  
Haleema Shakur-Still
Keyword(s):  
Traumatic Brain Injury ◽  
Statistical Analysis ◽  
Brain Injury ◽  
Primary Outcome ◽  
Randomised Trial ◽  
Statistical Analysis Plan ◽  
Intracranial Bleeding ◽  
Mechanistic Study ◽  
Cerebral Infarcts ◽  
Post Randomisation

Background: The CRASH-3 trial is a randomised trial on the effect of tranexamic acid (TXA) on death and disability in traumatic brain injury (TBI). The CRASH-3 intracranial bleeding mechanistic study (IBMS) is a randomised trial nested within the CRASH-3 trial to examine the effect of TXA on intracranial bleeding and infarction. Methods: Patients eligible for the CRASH-3 trial, with a GCS of 12 or less or intracranial bleeding on a pre-randomisation CT scan are eligible for the IBMS. The occurrence of intracranial bleeding, infarction, haemorrhagic oedematous lesions, mass effect and haemorrhage evacuation is examined within 28 days of randomisation using routinely collected brain scans. The primary outcome is the volume of intra-parenchymal bleeding in patients randomised within three hours of injury (adjusted for prognostic covariates). Secondary outcomes include a composite “poor” outcome, progressive and new intracranial bleeding, intracranial bleeding after neurosurgery and cerebral infarcts seen up to 28 days post-randomisation. All outcomes will be compared between treatment groups. Statistical analyses: The primary outcome will be analysed using a covariate adjusted linear mixed model. The same analysis will be done separately for patients who undergo haemorrhage evacuation post-randomisation. We will express the effect of TXA on the composite outcome, new and progressive bleeding using relative risks and 95% CIs, and on cerebral infarcts using hazard ratios and 95% CIs. We will conduct sensitivity analyses assuming missing data are MCAR or MNAR. Conclusion: The IBMS will provide information on the mechanism of action of TXA in TBI. This pre-specified statistical analysis plan is a technical extension of the published protocol. Trial registration: The CRASH-3 trial was prospectively registered at the International Standard Randomised Controlled Trials registry (19 July 2011) and ClinicalTrials.gov (25 July 2011). The registries were updated with details for the IBMS on 20 December 2016.

A multi-site, fixed dose, parallel arm, double-blind, placebo controlled, block randomised trial of the addition of infusional octreotide or placebo to regular ranitidine and dexamethasone for the evaluation of vomiting associated with bowel obstruction at the end of life.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS9153-TPS9153
Author(s):  
David C Currow ◽  
Katherine Clark ◽  
John Cartmill ◽  
Selvin Pather ◽  
John Plummer ◽  
...  
Keyword(s):  
Bowel Obstruction ◽  
Primary Outcome ◽  
Randomised Trial ◽  
Primary Outcome Measure ◽  
Fixed Dose ◽  
Management Problem ◽  
Double Blind ◽  
Isotonic Fluid ◽  
Net Clinical Benefit ◽  
First Time

TPS9153 Background: Bowel obstruction due to advanced cancer that is surgically inoperable is a major management problem. Studies to date have either been underpowered or have used comparators that may not draw on the best available evidence. Methods: This double-blind, block randomised, placebo controlled, set dose, parallel arm study was conducted across 12 sites in Australia. Eligibility included inoperable bowel obstruction secondary to cancer or its treatments. The intervention was the addition of infusional octreotide or placebo in addition to 200mg ranitidine per 24 hours parenterally and 4mg per 24 hours parenterally of dexamethasone. The primary outcome measure was the numbers of days free of vomiting up to 72 hours after all medications were administered the first time. Participants were also administered between 10-20mls per hour of subcutaneous isotonic fluid over the 72 hour period. Results: This study will close to recruitment in March 2012. To date 89 of 92 required participants have been randomised. Conclusions: This adequately powered study will define the additional net clinical benefit derived from octreotide over placebo in people who have an anti-secretary agent (ranitidine) and glucocorticoids (dexamethasone).

scholarly journals Efficacy of Chlorhexidine Varnish for the Prevention of Adult Caries

2011 ◽  
Vol 91 (2) ◽  
pp. 150-155 ◽  
Author(s):  
A.S. Papas ◽  
W.M. Vollmer ◽  
C.M. Gullion ◽  
J. Bader ◽  
R. Laws ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Tooth Surface ◽  
Placebo Control ◽  
Double Blind ◽  
Intention To Treat ◽  
Significant Difference ◽  
Registration Number ◽  
Secondary Outcomes ◽  
Study Participants ◽  
To Receive

The Prevention of Adult Caries Study, an NIDCR-funded multicenter, double-blind, randomized clinical trial, enrolled 983 adults (aged 18-80 yrs) at high risk for developing caries (20 or more intact teeth and 2 or more lesions at screening) to test the efficacy of a chlorhexidine diacetate 10% weight per volume (w/v) dental coating (CHX). We excluded participants for whom the study treatment was contraindicated or whose health might affect outcomes or ability to complete the study. Participants were randomly assigned to receive either the CHX coating (n = 490) or a placebo control (n = 493). Coatings were applied weekly for 4 weeks and a fifth time 6 months later. The primary outcome (total net D1-2FS increment) was the sum of weighted counts of changes in tooth surface status over 13 months. We observed no significant difference between the two treatment arms in either the intention-to-treat or per-protocol analyses. Analysis of 3 protocol-specified secondary outcomes produced similar findings. This trial failed to find that 10% (w/v) chlorhexidine diacetate coating was superior to placebo coating for the prevention of new caries ( Clinicaltrials.gov registration number NCT00357877).

scholarly journals Optimising outcomes of exercise and corticosteroid injection in patients with subacromial pain (impingement) syndrome: a factorial randomised trial

2020 ◽  
pp. bjsports-2019-101268
Author(s):  
Edward Roddy ◽  
Reuben O Ogollah ◽  
Raymond Oppong ◽  
Irena Zwierska ◽  
Praveen Datta ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Corticosteroid Injection ◽  
Randomised Trial ◽  
Clinical Effectiveness ◽  
Impingement Syndrome ◽  
Ultrasound Guided ◽  
Exercise Interventions ◽  
Intention To Treat ◽  
Registration Number ◽  
And Function

ObjectivesTo compare the clinical effectiveness of (1) physiotherapist-led exercise versus an exercise leaflet, and (2) ultrasound-guided subacromial corticosteroid injection versus unguided injection for pain and function in subacromial pain (formerly impingement) syndrome (SAPS).MethodsThis was a single-blind 2×2 factorial randomised trial. Adults with SAPS were randomised equally to one of four treatment groups: (1) ultrasound-guided corticosteroid injection and physiotherapist-led exercise, (2) ultrasound-guided corticosteroid injection and an exercise leaflet, (3) unguided corticosteroid injection and physiotherapist-led exercise and (4) unguided corticosteroid injection and an exercise leaflet. The primary outcome was the Shoulder Pain and Disability Index (SPADI), collected at 6 weeks, 6 and 12 months and compared at 6 weeks for the injection interventions and 6 months for the exercise interventions by intention to treat.ResultsWe recruited 256 participants (64 treatment per group). Response rates for the primary outcome were 94% at 6 weeks, 88% at 6 months and 80% at 12 months. Greater improvement in total SPADI score was seen with physiotherapist-led exercise than with the exercise leaflet at 6 months (adjusted mean difference −8.23; 95% CI −14.14 to -2.32). There were no significant differences between the injection groups at 6 weeks (−2.04; −7.29 to 3.22), 6 months (−2.36; −8.16 to 3.44) or 12 months (1.59; −5.54 to 8.72).ConclusionsIn patients with SAPS, physiotherapist-led exercise leads to greater improvements in pain and function than an exercise leaflet. Ultrasound guidance confers no additional benefit over unguided corticosteroid injection.Trial registration numberISRCTN42399123.

scholarly journals Sertraline in symptomatic chronic breathlessness: a double blind, randomised trial

2018 ◽  
Vol 53 (1) ◽  
pp. 1801270 ◽  
Author(s):  
David C. Currow ◽  
Magnus Ekström ◽  
Sandra Louw ◽  
Julie Hill ◽  
Belinda Fazekas ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Medical Research Council ◽  
Advanced Disease ◽  
Performance Status ◽  
Symptomatic Relief ◽  
Randomised Trial ◽  
Anxiety And Depression ◽  
Double Blind ◽  
Event Rates

Does sertraline provide symptomatic relief for chronic breathlessness in people with advanced disease whose underlying cause(s) are optimally treated?223 participants with chronic breathlessness (modified Medical Research Council breathlessness scale ≥2) who had optimal treatment of underlying cause(s) were randomised 1:1 to sertraline 25–100 mg (titrated upwards over 9 days) or placebo for 4 weeks. The primary outcome was the proportion who had an improvement in intensity of current breathlessness >15% from baseline on a 100-mm visual analogue scale.The proportion of people responding to sertraline was similar to placebo for current breathlessness on days 26–28 (OR 1.00, 95% CI 0.71–1.40) and for other measures of breathlessness. Quality of life in the sertraline arm had a higher likelihood of improving than in the placebo arm over the 4 weeks (OR 0.21, 95% CI 0.01–0.41; p=0.044). No differences in performance status, anxiety and depression, or survival were observed. Adverse event rates were similar between arms.Sertraline does not appear to provide any benefit over placebo in the symptomatic relief of chronic breathlessness in this patient population.

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