scholarly journals Adjunctive sepsis therapy with aminophylline (STAP): a randomized controlled trial

2021 ◽  
Author(s):  
Ruifang Zhang ◽  
Huan Liu ◽  
Dongmei Dai ◽  
Xianfei Ding ◽  
Dong Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Usual Care ◽  
Survival Time ◽  
Usual Care Group ◽  
Controlled Trial ◽  
Oxygenation Index ◽  
Care Group ◽  
Risk Of Death ◽  
Randomized Controlled

Abstract BackgroundSepsis is a serious disease that is often caused by infection. Aminophylline has anti-asthma and anti-inflammatory effects. We aimed to explore the safety and effect of aminophylline in sepsis.MethodsWe conducted a clinical randomized controlled trial involving 100 patients diagnosed with sepsis within 48 hours after ICU (intensive care unit) admission in two sites (First Affiliated Hospital of Zhengzhou University and First Affiliated Hospital of Kunming Medical University). All patients were randomized in a 1:1 ratio to receive standard therapy with or without aminophylline. The primary clinical outcome was all-cause mortality at 28 days.ResultsFrom 27 September 2018 to 12 February 2020, we screened 277 septic patients and eventually enrolled 100 patients, with 50 assigned to the aminophylline group and 50 to the usual-care group. At 28 days, 7 of 50 patients (14.0%) in the aminophylline group had died, compared with 16 of 50 (32.0%) in the usual-care group (P = 0.032). Cox regression showed that the aminophylline group had a lower risk of death (HR = 0.312, 95%CI: 0.129–0.753). Compared with the usual-care group, patients in the aminophylline group had a longer survival time (P = 0.039 by the log-rank test). With the extension of the treatment time, the effect of aminophylline on the doses of vasopressors, oxygenation index, and SOFA score increased. There were no significant differences in total hospitalization days, ICU hospitalization days, and rates of serious adverse events (all P > 0.05). No adverse events were observed in the trial.ConclusionsAminophylline as an adjunct therapy could significantly reduce the risk of death and prolong the survival time of patients with sepsis.Trial registrationThe trial was registered at the Chinese clinical trial registry (ChiCTR1800019173), 29 October 2018 - retrospectively registered, http://www.chictr.org.cn/index.aspx

scholarly journals Prevention of peritoneal dialysis-related peritonitis by regular patient retraining via technique inspection or oral education: a randomized controlled trial

2019 ◽  
Vol 35 (4) ◽  
pp. 676-686
Author(s):  
Ying Xu ◽  
Yuhui Zhang ◽  
Bin Yang ◽  
Suping Luo ◽  
Zhikai Yang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Peritoneal Dialysis ◽  
Usual Care ◽  
Usual Care Group ◽  
Controlled Trial ◽  
Care Group ◽  
Randomized Controlled ◽  
Education Group ◽  
Peking University ◽  
To Receive

Abstract Background There has been little research on strategies for prevention of peritoneal dialysis (PD)-related peritonitis. We explored whether regular retraining on bag exchanges (via two methods: technique inspection and oral education) every other month could help reduce the risk of peritonitis in PD patients through a randomized controlled trial (RCT). Method This is an RCT conducted at Peking University First Hospital. A total of 150 incident patients receiving PD at our centre were included between December 2010 and June 2016 and followed up until June 2018. Patients were randomly assigned 1:1:1 to receive retraining on bag exchange via technique inspection, oral education or usual care. The primary outcome was time to the first peritonitis episode. Secondary outcomes were time to organism-specific peritonitis, transfer to haemodialysis and all-cause death. Results Patients in the technique inspection group, oral education group and usual care group (n = 50 for each group) were followed up for 47.5 ± 22.9 months. Time to first peritonitis was comparable between the groups. The technique inspection group showed a lower risk of first non-enteric peritonitis than the usual care group, while the oral education group did not show a significant benefit. The incidence of first non-enteric peritonitis in the usual care group (0.07/patient-year) was significantly higher than that in the technique inspection group (0.02/patient-year; P < 0.01) but was comparable with that in the oral education group (0.06/patient-year). Transfer to haemodialysis and all-cause mortality were not significantly different between the groups. Conclusions Neither technique inspection nor oral education significantly altered the risk of all-cause peritonitis compared with usual care, despite technique inspection showing a trend towards reducing the risk of non-enteric PD-related peritonitis. Trial registration ClinicalTrials.gov (NCT01621997).

Effect of Artificial Intelligence on Nutritional Status of children post cardiac surgery; A Randomized Controlled Trial (Preprint)

2022 ◽  
Author(s):  
Maryam Zahid ◽  
Ume Sughra
Keyword(s):  
Nutritional Status ◽  
Usual Care ◽  
Usual Care Group ◽  
Mobile Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Care Group ◽  
Randomized Controlled ◽  
Nutritional Status Of Children ◽  
Post Cardiac Surgery

BACKGROUND Malnutrition is the most common problem in congenital heart diseases patients. Health based mobile applications play an important role in planning and tracking of diet for better nutritional status OBJECTIVE To assess the effect of artificial intelligence on nutritional status of children post cardiac surgery in comparison to usual care group. To assess usefulness of diet related mobile application in comparison to usual care group. METHODS This is a two arm randomized controlled trial that was conducted at a Tertiary Care Hospital, Rawalpindi. The study duration was 6 months from February 2021 till July 2021. Sample size was calculated to be 88. Intervention group was given a diet related mobile application and usual care group was handed a pamphlet with diet instructions on discharge. RESULTS Mean weight of all participants was 15 ± 5.7 kg at the time of discharge whereas at the end of 8th week mean weight of the participants in usual care group was 16.5 ± 7.2 kg and intervention group was 17.1 ± 5 kg. Average calories consumed by usual care group was 972 ± 252 kcal and 1000.75 ± 210 kcal by intervention group after 8 weeks of discharge. Average proteins consumed by the usual care group was 34.3 ± 12.5 grams and 39± 6.4 grams by intervention group after 8 weeks of discharge. At the end of intervention preferred diet planning tool for 79% of the participants was mobile application. At 8th week 93% of the participants considered the visual cues useful, 80% think that the mobile application language was understandable, 79% of the participants think nutritional goal setting is a useful feature in mobile application and 55% of the participants think the recipes in the application were useful. CONCLUSIONS The study showed strength for the future of scalable modern technology for self-nutrition monitoring. There was slight increase in the weight and nutritional intake of both groups as interventions period was limited. CLINICALTRIAL Study was registered on clinicaltrial.gov website with trial identity number NCT04782635.

scholarly journals Hydroxychloroquine for Early Treatment of Adults With Mild Coronavirus Disease 2019: A Randomized, Controlled Trial

2020 ◽  
Author(s):  
Oriol Mitjà ◽  
Marc Corbacho-Monné ◽  
Maria Ubals ◽  
Cristian Tebé ◽  
Judith Peñafiel ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Viral Load ◽  
Adverse Events ◽  
Usual Care ◽  
Symptom Onset ◽  
Early Treatment ◽  
Complete Resolution ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
The Mean

Abstract Background No effective treatments for coronavirus disease 2019 (COVID-19) exist. We aimed to determine whether early treatment with hydroxychloroquine (HCQ) would be efficacious for outpatients with COVID-19. Methods Multicenter open-label, randomized, controlled trial conducted in Catalonia, Spain, between 17 March and 26 May 2020. Patients recently diagnosed with <5-day of symptom onset were assigned to receive HCQ (800 mg on day 1 followed by 400 mg once daily for 6 days) or usual care. Outcomes were reduction of viral load in nasopharyngeal swabs up to 7 days after treatment start, disease progression up to 28 days, and time to complete resolution of symptoms. Adverse events were assessed up to 28 days. Results A total of 293 patients were eligible for intention-to-treat analysis: 157 in the control arm and 136 in the intervention arm. The mean age was 41.6 years (SD, 12.6), mean viral load at baseline was 7.90 log10 copies/mL (SD, 1.82), and median time from symptom onset to randomization was 3 days. No differences were found in the mean reduction of viral load at day 3 (−1.41 vs −1.41 log10 copies/mL in the control and intervention arm, respectively) or at day 7 (−3.37 vs −3.44). Treatment did not reduce risk of hospitalization (7.1% control vs 5.9% intervention) nor shorten the time to complete resolution of symptoms (12 days, control vs 10 days, intervention). No relevant adverse events were reported. Conclusions In patients with mild COVID-19, no benefit was observed with HCQ beyond the usual care.

scholarly journals Pharmacist-led counselling intervention to improve antiretroviral drug adherence in Pakistan: a randomized controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Zeenat Fatima Chatha ◽  
Usman Rashid ◽  
Sharon Olsen ◽  
Fakhar ud Din ◽  
Amjad Khan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Care Group ◽  
People Living With Hiv ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Cell Counts ◽  
Cd4 Cell

Abstract Background Pakistan is facing a growing population of people living with human immunodeficiency (HIV). In this randomized controlled trial, we investigate if a pharmacist-led intervention can increase adherence to antiretroviral therapy (ART) for people living with HIV (PLWH). Methods Adults with HIV, who have been taking ART for more than 3 months were randomly assigned to receive either a pharmacist-led intervention or their usual care. Measures of adherence were collected at 1) baseline 2) just prior to delivery of intervention and 3) 8 weeks later. The primary outcomes were CD4 cell count and self-reported adherence measured with the AIDS Clinical Trial Group (ACTG) questionnaire. Results Post-intervention, the intervention group showed a statistically significant increase in CD4 cell counts as compared to the usual care group (p = 0.0054). In addition, adherence improved in the intervention group, with participants being 5.96 times more likely to report having not missed their medication for longer periods of time (p = 0.0086) while participants in the intervention group were 7.74 times more likely to report missing their ART less frequently (p < 0.0001). Conclusions The findings support the improvement in ART adherence and HIV management. Trial registration The trial is registered with Australian New Zealand Clinical Trials Registry (ACTRN12618001882213). Registered 20 November 2018.

scholarly journals A Mobile Just-in-Time Adaptive Intervention for Smoking Cessation: Pilot Randomized Controlled Trial

10.2196/16907 ◽  
2020 ◽  
Vol 22 (3) ◽  
pp. e16907 ◽  
Author(s):  
Emily T Hébert ◽  
Chaelin K Ra ◽  
Adam C Alexander ◽  
Angela Helt ◽  
Rachel Moisiuc ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Usual Care ◽  
Controlled Trial ◽  
Care Group ◽  
Just In Time ◽  
Smartphone Apps ◽  
Adaptive Intervention ◽  
Randomized Controlled ◽  
Pilot Rct

Background Smartphone apps for smoking cessation could offer easily accessible, highly tailored, intensive interventions at a fraction of the cost of traditional counseling. Although there are hundreds of publicly available smoking cessation apps, few have been empirically evaluated using a randomized controlled trial (RCT) design. The Smart-Treatment (Smart-T2) app is a just-in-time adaptive intervention that uses ecological momentary assessments (EMAs) to assess the risk for imminent smoking lapse and tailors treatment messages based on the risk of lapse and reported symptoms. Objective This 3-armed pilot RCT aimed to determine the feasibility and preliminary efficacy of an automated smartphone-based smoking cessation intervention (Smart-T2) relative to standard in-person smoking cessation clinic care and the National Cancer Institute’s free smoking cessation app, QuitGuide. Methods Adult smokers who attended a clinic-based tobacco cessation program were randomized into groups and followed for 13 weeks (1 week prequitting through 12 weeks postquitting). All study participants received nicotine patches and gum and were asked to complete EMAs five times a day on study-provided smartphones for 5 weeks. Participants in the Smart-T2 group received tailored treatment messages after the completion of each EMA. Both Smart-T2 and QuitGuide apps offer on-demand smoking cessation treatment. Results Of 81 participants, 41 (50%) were women and 55 (68%) were white. On average, participants were aged 49.6 years and smoked 22.4 cigarettes per day at baseline. A total of 17% (14/81) of participants were biochemically confirmed 7-day point prevalence abstinent at 12 weeks postquitting (Smart-T2: 6/27, 22%, QuitGuide: 4/27, 15%, and usual care: 4/27, 15%), with no significant differences across groups (P>.05). Participants in the Smart-T2 group rated the app positively, with most participants agreeing that they can rely on the app to help them quit smoking, and endorsed the belief that the app would help them stay quit, and these responses were not significantly different from the ratings given by participants in the usual care group. Conclusions Dynamic smartphone apps that tailor intervention content in real time may increase user engagement and exposure to treatment-related materials. The results of this pilot RCT suggest that smartphone-based smoking cessation treatments may be capable of providing similar outcomes to traditional, in-person counseling. Trial Registration ClinicalTrials.gov NCT02930200; https://clinicaltrials.gov/show/NCT02930200

scholarly journals Efficacy of a Tailored Moisturizer for Reducing Chemotherapy-Induced Skin Dryness in Breast Cancer Patients: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Danbee Kang ◽  
Nayeon Kim ◽  
Young Hyuck Im ◽  
Yeon Hee Park ◽  
Ji Yeon Kim ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Usual Care ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Care Group ◽  
Breast Cancer Patients ◽  
Randomized Controlled

Abstract Introduction: While up to 60% of breast cancer patients undergoing chemotherapy experience skin side effects reducing quality of life, it was unclear which individual product was beneficial. To evaluate the effectiveness of a tailored moisturizer with a high content (1.5%) of pseudo-ceramides on skin dryness due to chemotherapy in breast cancer patients. Methods: Randomized controlled trial conducted from February 2015 to October 2018. 204 breast cancer patients experiencing skin dryness after 1 cycle of chemotherapy were randomly assigned to 3 groups (tailored moisturizer with high pseudo-ceramide content; general moisturizer; and usual care). Skin dryness, dullness, quality of life, and changes in sebum level were assessed at baseline, 3 weeks, and 1 month after completion of chemotherapy. The primary objective of the trial was to compare the tailored moisturizer group to usual care.Results: At 1 month after completion of chemotherapy, the tailored moisturizer group was significantly less likely to report severe skin dryness compared to the usual care group (8.5 vs. 27.9%, respectively, P < 0.01). The tailored moisturizer group reported significantly lower levels of skin dullness and lower levels of impairment of dermatological quality of life compared with the other two groups. Conclusions: A tailored moisturizer with a high content of pseudo-ceramides improved skin dryness, dullness and dermatological quality of life compared to usual care in breast cancer patients undergoing chemotherapy.

Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Sarah Dineen-Griffin ◽  
Victoria Garcia Cardenas ◽  
Kylie Williams ◽  
Shalom Isaac Benrimoj
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Community Pharmacies ◽  
Randomized Controlled ◽  
Minor Ailments ◽  
Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

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