scholarly journals The Availability and Safety Study of Remimazolam Besylate for Injection on Sedation of ERAS Patients Under Mechanical Ventilation in ICU: Protocol for a Randomized, Open-Label, Controlled Trial

2021 ◽  
Vol 8 ◽  
Author(s):  
Shengjun Liu ◽  
Longxiang Su ◽  
Bo Zhang ◽  
Huaiwu He ◽  
Zunzhu Li ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Rescue Therapy ◽  
Controlled Trial ◽  
Vital Signs ◽  
Open Label ◽  
Scientific Publications ◽  
Sedative Drug ◽  
College Hospital ◽  
Clinical Trial Registration ◽  
Medical College

Introduction: The most common physiological and psychological disorders associated with critical care patients are pain and anxiety. Sedatives and analgesics are commonly used to relieve these symptoms. However, the adverse effects of sedatives and analgesics are common and inevitable. As a new type of sedative drug, limited number of trials are available to evaluate Remimazolam Besylate's availability and safety compared with propofol.Methods: This study is a single center, randomized, open-label, controlled trial. A total of 84 patients who meet ERAS criteria and receive mechanical ventilation in ICU, aged ≥18 years old will be included. Patients will be randomized (1:1) into two groups: Remimazolam Besylate group and Propofol group. The Primary outcomes includes satisfaction rate of sedation and incidence rate of major clinical events. Secondary outcomes including incidence of delirium, time to weaning and extubation, Difficulty of nursing RASS, BIS and PI, 28-days survival, side-effect and vital signs during medications, total dose and dose per kilogram body weight of analgesic and sedatives and incidence of rescue therapy in experimental group.Ethics and Dissemination: This trial has been approved by the ethics boards of Peking Union Medical College Hospital. Recruitment began in January 2022 and will continue until June 2022. Dissemination plans include presentations at scientific conferences, scientific publications, stakeholder engagement efforts and presentation to the public via lay media outlets.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT04947345

Long- versus short-term androgen deprivation therapy with high-dose radiotherapy for biochemical failure after radical prostatectomy: a randomized controlled trial

2020 ◽  
Vol 16 (27) ◽  
pp. 2035-2044
Author(s):  
Charlien Berghen ◽  
Steven Joniau ◽  
Annouschka Laenen ◽  
Gaetan Devos ◽  
Kato Rans ◽  
...  
Keyword(s):  
Radical Prostatectomy ◽  
Androgen Deprivation Therapy ◽  
Controlled Trial ◽  
Locally Advanced ◽  
Lymph Node Involvement ◽  
Androgen Deprivation ◽  
High Dose ◽  
Open Label ◽  
Clinical Trial Registration ◽  
Substantial Risk

Radical prostatectomy is a well-established treatment option in the management of localized and locally advanced prostate cancer. An extended lymphadenectomy is performed in case of substantial risk for lymph node involvement. When biochemical recurrence (BCR) occurs, salvage radiotherapy (SRT) is performed. The benefit in terms of BCR-free survival (FS) and metastasis-FS by adding 6 months of androgen deprivation therapy (ADT) compared with SRT only has already been established. Retrospective evidence suggests that a longer schedule of ADT may be more beneficial compared with 6 months. This multicenter open-label randomized trial will include patients who need SRT after experiencing BCR post-radical prostatectomy with lymphadenectomy and pN0-status. Patients will be randomized for ADT duration (6 vs 24 months). Primary end point is distant metastasis-FS. Clinical Trial Registration: NCT04242017 ( ClinicalTrials.gov )

Roxadustat for anemia in patients with end-stage renal disease incident to dialysis

2021 ◽  
Author(s):  
Robert Provenzano ◽  
Evgeny Shutov ◽  
Liubov Eremeeva ◽  
Svitlana Korneyeva ◽  
Lona Poole ◽  
...  
Keyword(s):  
Rescue Therapy ◽  
Controlled Trial ◽  
Epoetin Alfa ◽  
Open Label ◽  
Treatment Groups ◽  
Intention To Treat ◽  
Primary Endpoints ◽  
Stage Renal Disease ◽  
End Stage ◽  
Event Rates

Abstract Background We evaluated the efficacy and safety of roxadustat vs. epoetin alfa for the treatment of chronic kidney disease (CKD) related anemia in patients new to dialysis. Methods This was a phase 3, open-label, epoetin alfa-controlled trial. Eligible adults were on hemodialysis/peritoneal dialysis for ≥2 weeks and ≤4 months before randomization and had mean hemoglobin ≤10.0 g/dL. Primary endpoints were mean hemoglobin (g/dL) change from baseline averaged over weeks 28–52 regardless of rescue therapy (non-inferiority criterion: lower limit of 95% CI for treatment difference > −0.75) and percentage of patients achieving a hemoglobin response between weeks 1–24 censored for rescue therapy (non-inferiority margin for between-group difference: −15%). Adverse events were monitored. Results The intention-to-treat population included patients randomized to roxadustat (n = 522) or epoetin alfa (n = 521). Mean (SD) hemoglobin changes from baseline averaged over weeks 28–52 were 2.57 (1.27) and 2.36 (1.21) in the roxadustat and epoetin alfa groups. Roxadustat was non-inferior (least-squares mean difference: 0.18 [95% CI: 0.08, 0.29]) to epoetin alfa. Percentages of patients with a hemoglobin response were 88.2% and 84.4% in the roxadustat and epoetin alfa groups. Roxadustat was non-inferior to epoetin alfa (treatment-group difference: 3.5% [95% CI: −0.7%, 7.7%]). Adverse event rates were comparable between treatment groups. Conclusions Roxadustat was efficacious for correcting and maintaining hemoglobin levels compared to epoetin alfa. Roxadustat had an acceptable safety profile.

scholarly journals Combination of InnoSEAL plus TR band compared with TR band alone for radial artery outcomes in patients undergoing transradial coronary intervention (InnoSEAL-II): an open-label randomised controlled trial (protocol)

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e042101
Author(s):  
Saba Aijaz ◽  
Sana Sheikh ◽  
Asad Pathan
Keyword(s):  
Randomised Controlled Trial ◽  
Radial Artery ◽  
Controlled Trial ◽  
Coronary Intervention ◽  
Ease Of Use ◽  
P Value ◽  
Radial Compression ◽  
Open Label ◽  
Scientific Publications ◽  
Randomised Controlled

IntroductionAbout 2%–30% of cardiac catheterisation procedures get complicated by radial artery occlusion (RAO). Ensuring patent haemostasis appears to be an important factor in reducing RAO. Currently employed method is a radial compression device (RCD) such as transradial band (TRB) that take hours to achieve haemostasis and cause discomfort to the patients. Haemostatic pads offer an alternative to RCD with reduced time to achieve haemostasis. Our trial aims to determine the non-inferiority of the catecholamine chitosan-based pad (InnoSEAL haemostatic pad) used in conjunction with TRB (InnoSEAL +TRB) when compared with the TRB alone in reducing composite adverse access site outcomes.Methods and analysisIt will be an open-label, parallel, randomised controlled trial on 714 adult patients (325 in each arm) undergoing coronary procedure using transradial approach at a cardiac health facility over 7 months duration. InnoSEAL patch along with TRB will be used to control bleeding in intervention arm and TRB alone in control arm, which is the standard practice. Study primary outcomes include RAO and haematoma; secondary outcomes are compression time, patient discomfort, time to discharge and ease of use of the intervention technique by the healthcare staff. χ2 test will be used to compare the categorical outcomes between two arms and student’s t-test for continuous outcomes. A p value of <0.05 will be considered significant.Ethics and disseminationEthical approval for the study has been obtained from the Institutional Review Board of Tabba Heart Institute number IORG0007863. Findings will be disseminated through seminars and scientific publications.Trial registration numberNCT04380883; Pre-results.

scholarly journals COVIDENZA - A prospective, multicenter, randomized PHASE II clinical trial of enzalutamide treatment to decrease the morbidity in patients with Corona virus disease 2019 (COVID-19): a structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Karin Welén ◽  
Anna K Överby ◽  
Clas Ahlm ◽  
Eva Freyhult ◽  
David Robinsson ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Virus Disease ◽  
Controlled Trial ◽  
Scale Up ◽  
Standard Of Care ◽  
University Hospital ◽  
Ordinal Scale ◽  
Open Label ◽  
Full Protocol ◽  
Exploration Phase

Abstract Objectives The main goal of the COVIDENZA trial is to evaluate if inhibition of testosterone signalling by enzalutamide can improve the outcome of patients hospitalised for COVID-19. The hypothesis is based on the observation that the majority of patients in need of intensive care are male, and the connection between androgen receptor signalling and expression of TMPRSS2, an enzyme important for SARS-CoV-2 host cell internalization. Trial design Hospitalised COVID-19 patients will be randomised (2:1) to enzalutamide plus standard of care vs. standard of care designed to identify superiority. Participants Included participants, men or women above 50 years of age, must be hospitalised for PCR confirmed COVID-19 symptoms and not in need of immediate mechanical ventilation. Major exclusion criteria are breast-feeding or pregnant women, hormonal treatment for prostate or breast cancer, treatment with immunosuppressive drugs, current symptomatic unstable cardiovascular disease (see Additional file 1 for further details). The trial is registered at Umeå University Hospital, Region Västerbotten, Sweden and 8 hospitals are approved for inclusion in Sweden. Intervention and comparator Patients randomised to the treatment arm will be treated orally with 160 mg (4x40 mg) enzalutamide (Xtandi®) daily, for five consecutive days. The study is not placebo controlled. The comparator is standard of care treatment for patients hospitalised with COVID-19. Main outcomes The primary endpoints of the study are (time to) need of mechanical ventilation or discharge from hospital as assessed by a clinical 7-point ordinal scale (up to 30 days after inclusion). Randomisation Randomisation was stratified by center and sex. Each strata was randomized separately with block size six with a 2:1 allocation ratio (enzalutamide + “standard of care”: “standard of care”). The randomisation list, with consecutive subject numbers, was generated by an independent statistician using the PROC PLAN procedure of SAS version 9.4 software (SAS Institute, Inc, Cary, North Carolina) Blinding (masking) This is an open-label trial. Numbers to be randomised (sample size) The trial is designed to have three phases. The first, an exploration phase of 45 participants (30 treatment and 15 control) will focus on safety and includes a more extensive laboratory assessment as well as more frequent safety evaluation. The second prolongation phase, includes the first 100 participants followed by an interim analysis to define the power of the study. The third phase is the continuation of the study up to maximum 600 participants included in total. Trial Status The current protocol version is COVIDENZA v2.0 as of September 10, 2020. Recruitment started July 29, 2020 and is presently in safety pause after the first exploration phase. Recruitment is anticipated to be complete by 31 December 2021. Trial registration Eudract number 2020-002027-10 ClinicalTrials.gov Identifier: NCT04475601, registered June 8, 2020 Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Probiotic prophylaxis to prevent ventilator associated pneumonia (VAP) in children on mechanical ventilation: an open-label randomized controlled trial

2015 ◽  
Vol 41 (4) ◽  
pp. 677-685 ◽  
Author(s):  
Balasubramaniam Banupriya ◽  
Niranjan Biswal ◽  
Rangan Srinivasaraghavan ◽  
Parameswaran Narayanan ◽  
Jharna Mandal
Keyword(s):  
Mechanical Ventilation ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Ventilator Associated Pneumonia ◽  
Open Label ◽  
Randomized Controlled

scholarly journals Ideal sedation for stroke thrombectomy: a prospective pilot single-center observational study

2019 ◽  
Vol 46 (2) ◽  
pp. E16 ◽  
Author(s):  
M. Asif Taqi ◽  
Sajid S. Suriya ◽  
Ajeet Sodhi ◽  
Syed A. Quadri ◽  
Mudassir Farooqui ◽  
...  
Keyword(s):  
Interventional Radiology ◽  
Ischemic Stroke ◽  
Controlled Trial ◽  
Time Interval ◽  
Open Label ◽  
Anterior Circulation ◽  
Clinical Trial Registration ◽  
Female Ratio ◽  
The Mean ◽  
The Difference

OBJECTIVESeveral retrospective studies have supported the use of conscious sedation (CS) over general anesthesia (GA) as the preferred methods of sedation for stroke thrombectomy, but a recent randomized controlled trial showed no difference in outcomes after CS or GA. The purpose of the Ideal Sedation for Stroke Thrombectomy (ISST) study was to evaluate the difference in time and outcomes in the reperfusion of anterior circulation in ischemic stroke using GA and monitored anesthesia care (MAC).METHODSThe ISST study was a prospective, open-label registry. A total of 40 patients who underwent mechanical thrombectomy for anterior circulation ischemic stroke were enrolled. Informed consent was obtained from each patient before enrollment. The primary endpoint included the interval between the patient’s arrival to the interventional radiology room and reperfusion time. Secondary endpoints were evaluated to estimate the effects on the outcome of patients between the 2 sedation methods.RESULTSOf the 40 patients, 32 received thrombectomy under MAC and 8 patients under GA. The male-to-female ratio was 18:14 in the MAC group and 4:4 in the GA group. The mean time from interventional radiology room arrival to reperfusion in the GA group was 2 times higher than that in the MAC group. Complete reperfusion (TICI grade 3) was achieved in more than 50% of patients in both groups. The mean modified Rankin Scale score at 3 months was < 2 in the MAC group and > 3 in the GA group (p = 0.021).CONCLUSIONSThe findings from the pilot study showed a significantly shorter time interval between IR arrival and reperfusion and better outcomes in patients undergoing reperfusion for ischemic stroke in the anterior circulation using MAC compared with GA.Clinical trial registration no.: NCT03036631 (clinicaltrials.gov)

scholarly journals Efficacy of colchicine in moderately symptomatic COVID-19 patients: a study protocol for a double-blind, randomized, placebo-controlled trial

2021 ◽  
Vol 8 (1) ◽  
pp. 43
Author(s):  
Motlabur Rahman ◽  
Mujibur Rahman ◽  
Ponkaj K. Datta ◽  
Khairul Islam ◽  
Pratyay Hasan ◽  
...  
Keyword(s):  
Standard Treatment ◽  
Controlled Trial ◽  
Ordinal Scale ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
College Hospital ◽  
Medical College ◽  
The Status ◽  
Anti Inflammatory ◽  
Study Participants

<p class="abstract"><strong>Background:</strong> Inflammation is playing a major role in the pathophysiology of severe COVID-19 disease. The main causes of mortality are cytokine syndrome and immune thromboembolism. Colchicine is an anti-inflammatory drug but its action is mediated by completely different pathophysiologic routes than that of corticosteroids and non-steroidal anti-inflammatory agents. Colchicine inhibits neutrophil chemotaxis, inhibits inflammasome signaling and reduces interleukin-1β, reduces neutrophil-platelet interaction and aggregation. Colchicine is a readily available, cheap drug, has been used safely for many years. Specific targeted anti-inflammatory drugs like tocilizuma and anakinra are costly. A previous study suggested a significant clinical benefit from colchicine in patients hospitalized with COVID-19. But they did not compare with placebo. So, we have designed this study.</p><p class="abstract"><strong>Methods:</strong> This is a prospective, double-blind, randomized, placebo-controlled clinical trial. The study will be conducted at Dhaka medical college hospital, Bangladesh. Real time-polymerase chain reaction (RT-PCR) positive COVID-19 patients with moderate symptoms will be included in this study. Participants will be randomized into two groups at 1:1 ratio. Patients of one group will be treated with standard treatment along with colchicine for 14 days. The patients in other group will be treated with standard treatment along with placebo for the same duration. The primary outcome of the study will be time to develop clinical deterioration, defined as the time from randomization to a deterioration of two points (from the status at randomization) on a seven-category ordinal scale.</p><p class="abstract"><strong>Conclusions: </strong>Enrolment of participants has begun at the study site. A total of 300 participants will be enrolled.</p><p class="abstract"><strong>Trial Registration:</strong> ClinicalTrials.gov identifier: NCT04527562.</p>

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