scholarly journals Intranasal insulin for treatment of delirium in older hospitalised patients: study protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e050765
Author(s):  
Anita Nitchingham ◽  
Andrew Milne ◽  
Barbara Toson ◽  
Bernard Tuch ◽  
Meera Agar ◽  
...  

IntroductionDelirium is one of the most common conditions diagnosed in hospitalised older people and is associated with numerous adverse outcomes, yet there are no proven pharmacological treatments. Recent research has identified cerebral glucose hypometabolism as a pathophysiological mechanism offering a therapeutic target in delirium. Insulin, delivered via the intranasal route, acts directly on the central nervous system and has been shown to enhance cerebral metabolism and improve cognition in patients with mild cognitive impairment and dementia. This trial will determine whether intranasal insulin can reduce the duration of delirium in older hospitalised patients.Methods and analysisThis is a prospective randomised, placebo-controlled, double-blind study with 6 months follow-up. One hundred patients aged 65 years or older presenting to hospital with delirium admitted under geriatric medicine will be recruited. Participants will be randomised to intranasal insulin detemir or placebo administered twice daily until delirium resolves, defined as Confusion Assessment Method (CAM) negative for 2 days, or discharge from hospital. The primary outcome measure will be duration of delirium using the CAM. Secondary outcome measures will include length of hospital stay, severity of delirium, adherence to treatment, hospital complications, new admission to nursing home, mortality, use of antipsychotic medications during hospital stay and cognitive and physical function at 6 months postdischarge.Ethics and disseminationThis trial has been approved by the South Eastern Sydney Human Research and Ethics Committee. Dissemination plans include submission to a peer-reviewed journal for publication and presentation at scientific conferences.Trial registration numberACTRN12618000318280.

Author(s):  
Sherief Abd-Elsalam ◽  
Ossama Ashraf Ahmed ◽  
Noha O. Mansour ◽  
Doaa H. Abdelaziz ◽  
Marwa Salama ◽  
...  

To date, no antiviral therapy has shown proven clinical effectiveness in treating patients with COVID-19. We assessed the efficacy of remdesivir in hospitalized Egyptian patients with COVID-19. Patients were randomly assigned at a 1:1 ratio to receive either remdesivir (200 mg on the first day followed by 100 mg daily for the next 9 days intravenously infused over 30–60 minutes) in addition to standard care or standard care alone. The primary outcomes were the length of hospital stay and mortality rate. The need for mechanical ventilation was assessed as a secondary outcome. Two hundred patients (100 in each group) completed the study and were included in the final analysis. The remdesivir group showed a significantly lower median duration of hospital stay (10 days) than the control group (16 days; P < 0.001). Eleven of the patients in the remdesivir group needed mechanical ventilation compared with eight patients in the control group (P = 0.469). The mortality rate was comparable between the two groups (P = 0.602). Mortality was significantly associated with older age, elevated C-reactive protein levels, elevated D-dimer, and the need for mechanical ventilation (P = 0.039, 0.003, 0.001, and < 0.001 respectively). Remdesivir had a positive influence on length of hospital stay, but it had no mortality benefit in Egyptian patients with COVID-19. Its use, in addition to standard care including dexamethasone, should be considered, particularly in low- and middle-income countries when other effective options are scarce.


2004 ◽  
Vol 10 (2) ◽  
pp. 93-102 ◽  
Author(s):  
J. Raymond ◽  
P. Leblanc ◽  
M. Chagnon ◽  
G. Gévry ◽  
J.-P. Collet ◽  
...  

Endovascular coiling can improve the outcome of patients with ruptured intracranial aneurysms, but angiographic recurrences are frequent compared to surgical clipping. New coils or devices have been introduced to improve long-term results of endovascular treatment but none have been the object of a valid clinical trial. We have proposed a multicentric randomized double-blind study comparing radioactive and standard coil occlusion of aneurysms. The purpose of this article is to review issues that are specific to the design of clinical trials to assess embolic agents that could improve the long-term efficacy of endovascular treatment of intracranial aneurysms. The proposed trial is a randomized, multi-center, prospective, controlled trial comparing the new generation coils to standard platinum coils. Blinding, if at all possible, is preferable to minimize bias, at least for follow-up angiographic studies that should cover a period of 18 months. All patients with an intracranial aneurysm eligible for endovascular treatment would be proposed to participate. The study would enrol approximately 500 patients equally divided between the two groups, recruited within two years, to demonstrate a decrease in the recurrence rate, the primary outcome measure, from 20% to 10%. Secondary outcome measures should assure that complications, initial clinical and angiographic results remain unchanged. Independent data safety and monitoring committees are crucial to the credibility of trials and to ensure scientific rigor and objectivity. The scientific demonstration of an improved long-term efficacy, without significant compromise regarding safety, is mandatory before considering the widespread use of a new embolic device for the endovascular treatment of aneurysms.


BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e040560
Author(s):  
Fen Dong ◽  
Ke Huang ◽  
Xiaoxia Ren ◽  
Shiwei Qumu ◽  
Hongtao Niu ◽  
...  

ObjectivesTo identify factors associated with length of stay (LOS) in chronic obstructive pulmonary disease (COPD) hospitalised patients, which may help shorten LOS and reduce economic burden accrued over hospital stay.DesignA retrospective cohort study.SettingThis study was performed in a tertiary hospital in China.ParticipantsPatients with COPD who were aged ≥40 years and newly admitted between 2016 and 2017.Primary and secondary outcome measuresLOS at initial admission was the primary outcome and health expenditures were the secondary outcome. To identify factors associated with LOS, we collected information at index hospitalisation and constructed a conceptual model using directed acyclic graph. Potential factors were classified into five groups: demographic information, disease severity, comorbidities, hospital admission and environmental factors. Negative binomial regression model was fitted for each block of factors and a parsimonious analysis was performed.ResultsIn total, we analysed 565 patients with COPD. The mean age was 69±11 years old and 69.4% were men. The median LOS was 10 (interquartile range 8–14) days. LOS was significantly longer in patients with venous thromboembolism (VTE) (16 vs 10 days, p=0.0002) or with osteoporosis (15 vs 10 days, p=0.0228). VTE ((rate ratio) RR 1.38, 95% CI 1.07 to 1.76), hypoxic–hypercarbic encephalopathy (RR 1.53, 95% CI 1.06 to 2.20), respiratory infection (RR 1.12, 95% CI 1.01 to 1.24), osteoporosis (RR 1.45, 95% CI 1.07 to 1.96) and emergence admission (RR 1.08, 95% CI 1.01 to 1.16) were associated with longer LOS. In parsimonious analysis, all these factors remained significant except emergency admission, highlighting the important role of concomitant morbidities in patients’ hospital stay. Total hospitalisation cost and patients’ out-of-pocket cost increased monotonically with LOS (both ptrend <0.0001).ConclusionPatients’ concomitant morbidities predicted excessive LOS in patients with COPD. Healthcare cost increased over the LOS. Quality improvement initiatives may need to identify patients at high risk for lengthy stay and implement early interventions to reduce COPD economic burden.


2021 ◽  
Author(s):  
Chandramohan Wakade ◽  
Raymond Chong ◽  
Marissa Seamon ◽  
Sharad Purohit ◽  
Bababihari Giri ◽  
...  

Abstract Background Parkinson's Disease (PD) patients have lower niacin levels compared to their spouses. The main objective was to study low-dose daily niacin supplementation on motor symptoms in Parkinson's disease subjects. Methods Forty-Seven PD patients were randomly assigned to receive low-dose niacin or placebo in a randomized, double-blind study for the first six months. After the double-blind phase, all participants received open-label niacin for the next six months. All patients were evaluated at baseline, six months, and one year of treatment. The main outcome measure was the Unified Parkinson's Disease Rating Scale III (UPDRS III) scores. Secondary outcome measures were depression, sleep quality, mental flexibility and cognition, and physical fatigue. Results Niacin treatment was tolerated well by 45 subjects. The baseline mean UPDRS III score was 21.3 ± 15.8 for the niacin group and 22.4 ± 11.8 for placebo. The change with six months of placebo was 1.5 [95% CI, -0.73 to 3.73], and niacin was − 1.06 [95% CI, -3.68 to 1.57]. From six to twelve months, the average UPDRS III score decreased for the placebo group by 2.66 [95% CI, -0.95 to 6.24] and the niacin group by 4.63 [95% CI, 1.42 to 7.83]. Eight subjects withdrew from the study before the 6-month time point and eight more before the one-year time point due to voluntary discontinuation, flushing, or inability to continue (SARS-CoV-2 shut-down). Conclusion Low-dose niacin supplementation may be helpful as an adjunct therapy in improving motor function in PD. Trial registration: Clinicaltrials.gov, NCT03462680. Registered 12 March 2018- Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03462680?term=gpr109A&draw=2&rank=1


Pain Medicine ◽  
2021 ◽  
Author(s):  
Yang Zhang ◽  
Jia Min ◽  
Shibiao Chen

Abstract Background The optimal analgesia regimen after open cardiac surgery was unclear. The aim of this study was to investigate the beneficial effects of continuous Pecto-Intercostal Fascial Block (PIFB) blocks initiated before surgery on outcomes following open cardiac surgery. Methods A group of 116 patients were randomly allocated to either receive bilateral continuous PIFB (PIF group) or the same block with saline (SAL group). The primary endpoint was postoperative pain at 4, 8, 16, 24, 48, and 72 h after extubation at rest and exercise. The secondary outcome measures included analgesia requirements (sufentanil and flurbiprofen consumption), time to extubation, length of stay in the ICU, incidence of postoperative nausea and vomiting (PONV), time until return of bowel function, time to mobilization, urinary catheter removal and the length of hospital stay. Results The length of stay in the ICU (29 ± 7 h vs 13 ± 4 h, p &lt; 0.01) and length of hospital stay (8.9 ± 0.9 d vs 6.5 ± 1.1 d, p &lt; 0.01) was significantly longer in the SAL group than in the PIF group. Resting pain scores (2 h after extubation : 1.1 vs 3.3, p &lt; 0.01; 4 h after extubation : 1.0 vs 3.5, p &lt; 0.01; 8 h after extubation : 1.2 vs 3.7, p &lt; 0.01; 16 h after extubation : 1.3 vs 3.7, p &lt; 0.01; 24 h after extubation : 1.4 vs 2.8, p &lt; 0.01; 48 h after extubation : 0.9 vs 2.2, p &lt; 0.01; 72 h after extubation : 0.8 vs 2.1, p &lt; 0.01) and dynamic pain scores (2 h after extubation : 1.4 vs 3.7, p &lt; 0.01; 4 h after extubation : 1.3 vs 3.8, p &lt; 0.01; 8 h after extubation : 1.4 vs 3.5, p &lt; 0.01; 16 h after extubation : 1.2 vs 3.4, p &lt; 0.01; 24 h after extubation : 1.1 vs 3.1, p &lt; 0.01; 48 h after extubation : 1.0 vs 2.9, p &lt; 0.01; 72 h after extubation: 0.9 vs 2.8, p &lt; 0.01) were significantly lower in PIF group compared with SAL group at all time points. The PIF group required significantly less intraoperative (123 ± 32 μg vs 63 ± 16 μg, p &lt; 0.01) and postoperative sufentanil (102 ± 22 μg vs 52 ± 17 μg, p &lt; 0.01) consumption, postoperative flurbiprofen consumption (350 ± 100 mg vs 100 ± 100 mg, p &lt; 0.01) than the SAL groups. Time to extubation (8.9 ± 2.4 h vs 3.2 ± 1.3 h, p &lt; 0.01), time to first flatus (43 ± 6 h vs 30 ± 7 h, p &lt; 0.01), time until mobilization (35 ± 5 h vs 24 ± 7 h, p &lt; 0.01), time until urinary catheter removal (47 ± 9 h vs 31 ± 4 h, p &lt; 0.01) was significantly earlier in the PIF group than in the SAL group. The incidence of PONV was significantly lower in the PIF group (9.1% vs 27.3%, p &lt; 0.01). Conclusion Bilateral continuous PIFB reduced the length of hospital stay and provided effective postoperative pain for three days.


2020 ◽  
Vol 49 (12) ◽  
pp. 996-1008
Author(s):  
Jamie SY Ho ◽  
Daniel I Fernando ◽  
Mark Y Chan ◽  
Ching-Hui Sia

Abstract Objective: Obesity has been shown to be associated with adverse outcomes in viral infections such as influenza, but previous studies on coronavirus disease 2019 (COVID-19) had mixed results. The aim of this systematic review is to investigate the relationship between COVID-19 and obesity. Methods: We performed a systematic review and meta-analysis. A literature search of MEDLINE, EMBASE, Scopus, Web of Science, CENTRAL, OpenGrey and preprint servers medRxiv and bioRxiv was performed, with no restriction on language or date of publication. Primary outcomes of this study were intensive care unit (ICU) admission or critical disease, severe disease and mortality. Secondary outcome was a positive COVID-19 test. Meta-analysis was performed using OpenMeta-Analyst software, and heterogeneity was tested using Cochran’s Q test and I2 statistic. The study protocol was registered on PROSPERO (CRD42020184953). Results: A total of 1,493 articles were identified and 61 studies on 270,241 patients were included. The pooled prevalence of obesity was 27.6% (95% confidence interval [CI] 22.0–33.2) in hospitalised patients. Obesity was not significantly associated with increased ICU admission or critical illness (odds ratio [OR] 1.25, 95% CI 0.99–1.58, P=0.062, I2=31.0) but was significantly associated with more severe disease (OR 3.13, 95% CI 1.41–6.92, P=0.005, I2=82.6), mortality (OR 1.36, 95% CI 1.09–1.69, P=0.006, I2=88.5) and a positive COVID-19 test (OR 1.50, 95% CI 1.25–1.81, P<0.001). Conclusion: Obesity increased the risk of severe disease, mortality and infection with COVID-19. Higher body mass index was associated with ICU admission and critical disease. Patients who are obese may be more susceptible to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, and infected patients should be monitored closely for adverse outcomes. Keywords: Body mass index, coronavirus, intensive care, mortality, prognosis


2017 ◽  
Vol 87 (1-2) ◽  
pp. 10-16 ◽  
Author(s):  
Salah Gariballa ◽  
Awad Alessa

Abstract. Background: ill health may lead to poor nutrition and poor nutrition to ill health, so identifying priorities for management still remains a challenge. The aim of this report is to present data on the impact of plasma zinc (Zn) depletion on important health outcomes after adjusting for other poor prognostic indicators in hospitalised patients. Methods: Hospitalised acutely ill older patients who were part of a large randomised controlled trial had their nutritional status assessed using anthropometric, hematological and biochemical data. Plasma Zn concentrations were measured at baseline, 6 weeks and at 6 months using inductively- coupled plasma spectroscopy method. Other clinical outcome measures of health were also measured. Results: A total of 345 patients assessed at baseline, 133 at 6 weeks and 163 at 6 months. At baseline 254 (74%) patients had a plasma Zn concentration below 10.71 μmol/L indicating biochemical depletion. The figures at 6 weeks and 6 months were 86 (65%) and 114 (70%) patients respectively. After adjusting for age, co-morbidity, nutritional status and tissue inflammation measured using CRP, only muscle mass and serum albumin showed significant and independent effects on plasma Zn concentrations. The risk of non-elective readmission in the 6-months follow up period was significantly lower in patients with normal Zn concentrations compared with those diagnosed with Zn depletion (adjusted hazard ratio 0.62 (95% CI: 0.38 to 0.99), p = 0.047. Conclusions: Zn depletion is common and associated with increased risk of readmission in acutely-ill older patients, however, the influence of underlying comorbidity on these results can not excluded.


2014 ◽  
Vol 155 (51) ◽  
pp. 2028-2033 ◽  
Author(s):  
Judit Hallay ◽  
Dániel Nagy ◽  
Béla Fülesdi

Malnutrition in hospitalised patients has a significant and disadvantageous impact on treatment outcome. If possible, enteral nutrition with an energy/protein-balanced nutrient should be preferred depending on the patient’s condition, type of illness and risk factors. The aim of the nutrition therapy is to increase the efficacy of treatment and shorten the length of hospital stay in order to ensure rapid rehabilitation. In the present review the authors summarize the most important clinical and practical aspects of enteral nutrition therapy. Orv. Hetil., 2014, 155(51), 2028–2033.


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