Dataset Information

MuLTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19-Experimental drugs and mechanisms (TACTIC-E): A structured summary of a study protocol for a randomized controlled trial.

ABSTRACT:

SUBMITTER: Lu IN

PROVIDER: S-EPMC7393245 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

muLTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19-Experimental drugs and mechanisms (TACTIC-E): A structured summary of a study protocol for a randomized controlled trial.

Lu Ing Ni IN Kulkarni Spoorthy S Fisk Marie M Kostapanos Michalis M Banham-Hall Edward E Kadyan Sonakshi S Bond Simon S Norton Sam S Cope Andrew A Galloway James J Hall Frances F Jayne David D Wilkinson Ian B IB Cheriyan Joseph J

Trials 20200731 1

<h4>Objectives</h4>To determine if a specific intervention reduces the composite of progression of patients with COVID-19-related disease to organ failure or death as measured by time to incidence of any one of the following: death, invasive mechanical ventilation, ECMO, cardiovascular organ support (inotropes or balloon pump), or renal failure (estimated Cockcroft Gault creatinine clearance <15ml/min).<h4>Trial design</h4>Randomised, parallel arm, open-label, adaptive platform Phase 2/3 trial o ...[more]

PMID: 32736592

Similar Datasets

Project description:Anti-dementia drugs may improve gait performance. No comparison between acetylcholinesterase inhibitors (CEIs) and memantine-related changes in gait variability has been reported. The objectives of this study were to 1) quantify and compare the mean values and coefficients of variation (CoV) of stride time in demented patients with Alzheimer's disease and related disorders (ADRD) before and after the use of CEIs or memantine, and in age- and gender-matched controls patients with ADRD using no anti-dementia drugs; and 2) to determine whether changes in CoV of stride time differed between CEIs or memantine.A total of 120 demented patients with mild-to-moderate ADRD were prospectively included in this pre-post quasi-experimental study with two intervention groups (43 patients taking CEIs, and 41 taking memantine) and a control group (36 age- and gender matched patients without any anti-dementia drugs). CoV of stride time and walking speed were measured with GAITRite® system while usual walking at steady state. Age, gender, number of drugs daily taken, use of psychoactive drugs, body mass index and time between the two visits were also recorded.There was no difference between groups for the time between baseline and follow-up assessments (232.9 ± 103.7 days for patients without anti-dementia drugs, 220.0 ± 67.5 days for patients with CEIs, 186.7 ± 96.2 days for patients with memantine, P?=?0.062). Patients with memantine had a lower (i.e., better) CoV of stride time at follow-up assessment compared to those with CEIs (4.2 ± 2.4% versus 5.8 ± 4.2%, P?=?0.010). Patients with memantine had a greater decrease in CoV of stride time compared to those with CEIs (-1.90% versus 0.93%, P?=?0.010) and mixed-effects linear regressions showed that this decrease was specifically explained by memantine (P?=?0.028).Our results showed that patients with ADRD and treated with memantine, but not those with CEIs, decreased their gait variability, and thus improved their gait safety (Trial registration number: NCT01315704).

Project description:BackgroundCoagulation abnormalities in COVID-19 patients have not been addressed in depth.ObjectiveTo perform a longitudinal evaluation of coagulation profile of patients admitted to the ICU with COVID-19.MethodsConventional coagulation tests, rotational thromboelastometry (ROTEM), platelet function, fibrinolysis, antithrombin, protein C and S were measured at days 0, 1, 3, 7 and 14. Based on median total maximum SOFA score, patients were divided in two groups: SOFA ≤ 10 and SOFA > 10.ResultsThirty patients were studied. Some conventional coagulation tests, as aPTT, PT and INR remained unchanged during the study period, while alterations on others coagulation laboratory tests were detected. Fibrinogen levels were increased in both groups. ROTEM maximum clot firmness increased in both groups from Day 0 to Day 14. Moreover, ROTEM-FIBTEM maximum clot firmness was high in both groups, with a slight decrease from day 0 to day 14 in group SOFA ≤ 10 and a slight increase during the same period in group SOFA > 10. Fibrinolysis was low and decreased over time in all groups, with the most pronounced decrease observed in INTEM maximum lysis in group SOFA > 10. Also, D-dimer plasma levels were higher than normal reference range in both groups and free protein S plasma levels were low in both groups at baseline and increased over time, Finally, patients in group SOFA > 10 had lower plasminogen levels and Protein C than patients with SOFA <10, which may represent less fibrinolysis activity during a state of hypercoagulability.ConclusionCOVID-19 patients have a pronounced hypercoagulability state, characterized by impaired endogenous anticoagulation and decreased fibrinolysis. The magnitude of coagulation abnormalities seems to correlate with the severity of organ dysfunction. The hypercoagulability state of COVID-19 patients was not only detected by ROTEM but it much more complex, where changes were observed on the fibrinolytic and endogenous anticoagulation system.

Project description:IntroductionAuto-intoxication represents a considerable number of Intensive care unit (ICU) admissions. Literature focusing on characteristics and outcomes of ICU-admitted auto-intoxicated patients is limited.ObjectivesWe aimed to identify the quantity of intensive care admissions attributable to auto-intoxication in a Belgian tertiary center, to examine characteristics and outcomes of these patients, and to assess the impact of the covid-19 pandemic on these variables.MethodsIn this retrospective cohort study, all patients admitted to the ICU of JESSA hospital, Hasselt, Belgium with a diagnosis of auto-intoxication between January 1st 2017 and December 31st 2022, were included in the study. We collected data on patient characteristics, comorbidities, type of intoxication and outcomes including the length of ICU and hospital stay and mortality.ResultsIn total, 342 patients were included in the dataset, covering 2.44% of all ICU admissions from January 1st 2017 to December 31st 2022. Although auto-intoxication occurred in all age-categories, the age group from 18 to 29 years old, showed the highest prevalence (24%). More woman (57.6%) than man (42.4%) were included in the study. Of all included patients, 21.6% had a history of previous suicide attempt and 36.5% of previous auto-intoxication. The most common substances ingested were sedatives (44.4%), illicit drugs (20.2%), analgesics (17.8%), and antidepressants (16.7%) whereas in 54.1% of the cases, a combination of substances was ingested. Type of intoxication was separated into four groups: suicide attempt, accidental, iatrogenic and recreational use with suicide attempt accounting for 71.3% of all auto-intoxications. The prevalence of ICU-admitted auto-intoxicated patients remained stable over the 5-year study period. An impact of the Covid-19 pandemic on this prevalence could not be established. Overall mortality was low with an ICU- and hospital mortality of 1.75% and 2.6% respectively. Total mortality at time of dataset closure, on the other hand, was 7.2%.ConclusionsThe impact of auto-intoxication on ICU resource utilization is relatively high and the risk of recidivism is substantial. ICU- and in-hospital mortality after auto-intoxication is low, although these patients have a substantial risk for death in years to come after hospital discharge.

Project description:BACKGROUND:Tuberculous meningitis (TBM) is a devastating infection in tuberculosis endemic areas with limited access to intensive care. Functional outcomes of severe adult TBM patients admitted to the ICU in nonendemic areas are not known. METHODS:We conducted a retrospective multicenter cohort study (2004-2016) of consecutive TBM patients admitted to 12 ICUs in the Paris area, France. Clinical, biological, and brain magnetic resonance imaging (MRI) findings at admission associated with a poor functional outcome (i.e., a score of 3-6 on the modified Rankin scale (mRS) at 90 days) were identified by logistic regression. Factors associated with 1-year mortality were investigated by Cox proportional hazards modeling. RESULTS:We studied 90 patients, of whom 61 (68%) had a score on the Glasgow Coma Scale ≤ 10 at presentation and 63 (70%) required invasive mechanical ventilation. Brain MRI revealed infarction and hydrocephalus in 38/75 (51%) and 25/75 (33%) cases, respectively. A poor functional outcome was observed in 55 (61%) patients and was independently associated with older age (adjusted odds ratio (aOR) 1.03, 95% CI 1.0-1.07), cerebrospinal fluid protein level ≥ 2 g/L (aOR 5.31, 95% CI 1.67-16.85), and hydrocephalus on brain MRI (aOR 17.2, 95% CI 2.57-115.14). By contrast, adjunctive steroids were protective (aOR 0.13, 95% CI 0.03-0.56). The multivariable adjusted hazard ratio of adjunctive steroids for 1-year mortality (47%, 95% CI 37%-59%) was 0.23 (95% CI 0.11-0.44). Among survivors at 1 year, functional independence (mRS of 0-2) was observed in 27/37 (73%, 95% CI 59%-87%) cases. CONCLUSIONS:A poor functional outcome in adult TBM patients admitted to the ICU in a nonendemic area is observed in 60% of cases and is independently associated with elevated cerebrospinal fluid protein level and hydrocephalus. Our data also suggest a protective effect of adjunctive steroids, with reduced disability and mortality, irrespective of immune status and severity of disease at presentation. One-year follow-up revealed functional independence in most survivors.

Project description:BACKGROUND: Summary measures of health that combine mortality and morbidity into a single indicator are being estimated in the Canadian context for approximately 200 diseases and conditions. To manage the large amount of data and calculations for this many diseases, we have developed a structured workbook system with easy to use tools. We expect this system will be attractive to researchers from other countries or regions of Canada who are interested in estimating the health-adjusted life years (HALYs) lost to premature mortality and year-equivalents lost to reduced functioning, as well as population attributable fractions (PAFs) associated with risk factors. This paper describes the workbook system using cancers as an example, and includes the entire system as a free, downloadable package. METHODS: The workbook system was developed in Excel and runs on a personal computer. It is a database system that stores data on population structure, mortality, incidence, distributions of cases entering a multitude of health states, durations of time spent in health states, preference scores that weight for severity, life table estimates of life expectancies, and risk factor prevalence and relative risks. The tools are Excel files with embedded macro programs. The main tool generates workbooks that estimate HALY, one per disease, by copying data from the database into a pre-defined template. Other tools summarize the HALY results across diseases for easy analysis. RESULTS: The downloadable zip file contains the database files initialized with Canadian data for cancers, the tools, templates and workbooks that estimate PAF and a user guide. The workbooks that estimate HALY are generated from the system at a rate of approximately one minute per disease. The resulting workbooks are self-contained and can be used directly to explore the details of a particular disease. Results can be discounted at different rates through simple parameter modification. CONCLUSION: The structured workbook approach offers researchers an efficient, easy to use, and easy to understand set of tools for estimating HALY and PAF summary measures for their country or region of interest.

Dataset Information

MuLTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19-Experimental drugs and mechanisms (TACTIC-E): A structured summary of a study protocol for a randomized controlled trial.

Publications

muLTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19-Experimental drugs and mechanisms (TACTIC-E): A structured summary of a study protocol for a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets