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Copd Exacerbation Acute clinical trials

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NCT ID: NCT05734365 Recruiting - Clinical trials for COPD Exacerbation Acute

COPD-ICU Multicentre Prospective Observational Register

COPD-ICU
Start date: November 1, 2022
Phase:
Study type: Observational [Patient Registry]

COPD is one of the leading causes of morbidity, mortality and health care utilisation worldwide. Currently, COPD is the third leading cause of death worldwide and is therefore a major public health problem. Projections show an increase in the prevalence and burden of COPD in the coming decades due to ageing populations and continued exposure to risk factors. In patients with COPD, mortality due to exacerbations is about 35%. Exacerbations represent the most important respiratory event in the history of this chronic disease and are of major socio-economic interest (about 50-75% of healthcare expenditure in this disease). In the most severe cases, COPD exacerbations lead to respiratory distress with hypercapnic ventilatory acidosis requiring ventilatory support. These most severe episodes are common, accounting for 20% of exacerbations and are a signal of advanced disease, with a high risk of future hospitalisations and a limited long-term prognosis. Despite progress in management, the mortality of these severe acute exacerbations is around 15% in the ICU and 20% in hospital. The long-term prognosis following hospitalisation for an acute exacerbation of COPD is poor with a 5-year mortality of around 50%. On the one hand, the means and treatments likely to improve the prognosis of these patients are of great medical and socio-economic interest, on the other hand, it seems important to identify the elements that may be associated with management failure and to treat them where appropriate. Thus, improving scientific knowledge thanks to prospective data, evaluating the different characteristics and prognosis of patients hospitalised for a severe acute exacerbation of COPD seems, in the 21st century, a major axis in order to continue to optimise the individual management of these patients but also collectively, given the COPD public health burden.

NCT ID: NCT05568043 Recruiting - COPD Clinical Trials

The Reducing REVISITS Study: A Cluster RCT

REVISITS
Start date: February 15, 2022
Phase: N/A
Study type: Interventional

This type II hybrid effectiveness-implementation trial will concurrently study the comparative effectiveness of virtual vs. in-person COPD care transition programs implemented via virtual mentored implementation approaches with and without co-design methods. The investigators will enroll up to 24 randomized sites (with a goal minimum of 16 sites) to: - Deliver the COPD programs implemented via mentored support in collaboration with SHM Center for Quality Improvement. - Compare the effectiveness and penetration of virtual versus in-person COPD care transition programs implemented along with mentoring support with or without co-design. The investigators aim to determine which combined approach(es) is/are the most effective at implementing evidence-based COPD program interventions and decreasing COPD acute care revisits with the greatest overall impact and sustainability.

NCT ID: NCT05452226 Recruiting - Clinical trials for Community-acquired Pneumonia

Neuromuscular Electrical Stimulation in COPD/Community Acquired Pneumonia

Start date: July 12, 2022
Phase: N/A
Study type: Interventional

In older adults hospitalized for acute medical conditions, immobility, clinical treatments, and the illness itself contribute to physical deconditioning and delirium, hospital-acquired impairments that increase risk for long-term physical and mental disability, other morbidities, and death. In patients with acute respiratory failure, hospital-acquired functional impairments persist long after hospitalization, due to limited use to rehabilitative interventions in the inpatient or post-acute settings. Exercise and early mobilization interventions are safe and improve physical and cognitive impairments, but there are critical barriers to their widespread implementation in acute care and home settings, including mobility limitations, reduced cardiopulmonary reserve, limited staff, and costs. Thus, there is an unmet need to develop interventions that can be utilized in both the inpatient and home environments to improve functional recovery in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) and community-acquired pneumonia (CAP). This study addresses this clinical need and these barriers and will provide important feasibility and acceptability data regarding the utility of neuromuscular electrical stimulation (NMES) administered to lower extremity musculature across inpatient and post-discharge settings to improve functional and cognitive recovery in older adults hospitalized for AECOPD/CAP. Initial NMES sessions will begin during participants' stay at UVM Medical Center and will continue at home after hospital discharge. Study participants will be issued a portable NMES device to take home and instructed on its use. They will receive guidance and oversight on the use of the NMES device and will be asked to perform NMES treatments 6 days per week for 60 minutes per day for 6 weeks. Data will be collected via activity monitor, participant questionnaires and clinical assessments including strength testing and 6-minute-walk-test.

NCT ID: NCT05400369 Recruiting - Clinical trials for COPD Exacerbation Acute

A Study to Evaluate the Efficacy and Safety of Sitafloxacin in Adult Subjects With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Start date: August 10, 2022
Phase: Phase 4
Study type: Interventional

Chronic obstructive pulmonary disease (COPD) is a common, preventable, and treatable disease, that causes obstructed airflow from the lungs that causes persistent obstructive airflow limitation. Acute exacerbation, especially frequent exacerbation, is associated with an increased risk of death in COPD patients. The most common causes of acute attacks are viral and bacterial infections. This study will assess the efficacy and safety of sitafloxacin, a quinolone antibacterial drug, in participants with AECOPD.

NCT ID: NCT05012033 Recruiting - Asthma Clinical Trials

Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting

EHD-Pred PK
Start date: April 12, 2023
Phase:
Study type: Observational

This is a pilot study to investigate serum prednisolone profiles in: - Patients on high doses of prednisolone for any inflammatory disorder, both in the acute and chronic setting. - Patients stepping up from or down to prednisolone therapy in association with a course of high dose methyl-prednisolone or dexamethasone. The study will comprise 3 groups, including those started on high doses of prednisolone acutely in an inpatient or outpatient setting, participants on chronically high doses, and those receiving a several week course of high dose methylprednisolone or dexamethasone. The study aims to measure prednisolone levels at a number of time points to investigate serum profile differences in those receiving prednisolone acutely compared with longer term steroid use. Further samples will be taken to characterise additional metabolic changes.

NCT ID: NCT04881409 Recruiting - Clinical trials for COPD Exacerbation Acute

Nasal High-flow Compared to Non-invasive Ventilation in Treatment of Acute Acidotic Hypercapnic Exacerbation of Chronic Obstructive Pulmonary Disease

Start date: May 6, 2021
Phase: N/A
Study type: Interventional

The ELVIS study compares the nasal high-flow to non-invasive ventilation in treatment of acute acidotic hypercapnic exacerbation of chronic obstructive pulmonary disease.

NCT ID: NCT04710849 Recruiting - COPD Clinical Trials

Relationship Between Plasma Metabolome and the Efficacy of Systemic Glucocorticoid in AECOPD

Start date: February 1, 2021
Phase:
Study type: Observational [Patient Registry]

Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) significantly increases the mortality of the patients with COPD. Guidelines have recommended systemic glucocorticoid as regular treatment. Recently, evidences have shown that systemic glucocorticoid cannot not be benefit to all of the patients with AECOPD. Thus the problem that how the clinicians can screen the patients who can benefit from systemic glucocorticoid needs to be solved urgently.

NCT ID: NCT03981081 Recruiting - Clinical trials for Mechanical Ventilation

Prednisone Reduction in ICU Patients With COPD Exacerbation

EoPred-ICU
Start date: April 2, 2019
Phase: Phase 4
Study type: Interventional

The aim of this multicenter, investigator-initiated, prospective, randomized, open-label, non-inferiority study is to evaluate a prednisone prescribing strategy, guided by eosinophil blood count compared to the standard (systematic) administration of corticosteroids, in patients with COPD exacerbation requiring ventilatory support. Patients fulfilling inclusion criteria and consenting to participate in the study, will be randomized through a random table generated electronically, to eosinophil-guided group or to control group. In the eosinophil-guided group, prednisone (1mg/kg/day for up to 5 days or during the hospital stay if less than 5 days) is administered only if the eosinophil count is >2%. If blood eosinophil count is ≤2%, no corticosteroids are given. In the control group: a treatment based on prednisone at a daily dose of 1 mg/kg will be routinely administered for a maximum of 5 days, or during the hospital stay, if it is less than 5 days. Corticosteroid treatment is taken in the morning in patients with NIV, and through the gastric tube in intubated patients. The hypothesis tested is a non-inferiority of the "eosinophil-guided strategy" compared to the standard strategy, with less exposure to corticosteroids. The primary endpoint is the proportion of unventilated patients at day 6 which is set to 50% in the control group. A pre-specified difference <10% would be a non-inferiority margin. Secondary endpoints are: Number of ICU days alive without ventilatory support within 28 days after recruitment, length of stay in intensive care Unit, the intubation rate in patients initially under NIV, Mortality in the ICU, Hospital mortality. Safety: New onset of diabetes or worsening of diabetes requiring the start or the increase in insulin therapy, Upper gastrointestinal bleeding (2 g drop of Hb requiring blood transfusion or fibroscopy), Uncontrolled hypertensive crisis requiring the introduction of new antihypertensives, ICU-acquired neuromyopathy, Nosocomial infection, Relapse rate / recurrence defined respectively by the rate of a new hospital consultation and/or admission in the week or the month following index hospitalization. Sample size calculation: In a non-inferiority study, with an incidence of the event (no ventilation at D6) of 50% in the control group ( with 10% of acceptable difference for non-inferiority), a power of 80% and alpha error <0.05, it would take 86 patients per arm by anticipating 2% of lost sight.

NCT ID: NCT03680495 Recruiting - COPD Clinical Trials

Steroid Resistance During COPD Exacerbations With Respiratory Failure

Start date: July 21, 2017
Phase:
Study type: Observational [Patient Registry]

Chronic obstructive pulmonary disease (COPD) is a lung disease caused by cigarette smoke that affects millions of people. In the United States, COPD is the 3rd leading cause of death making it one of our most important public health problems. Some people with COPD get disease flares that are called acute exacerbations of COPD - or AECOPDs for short. When people get an AECOPD they experience increased shortness of breath, wheezing and cough; symptoms that often require urgent or emergent treatment by healthcare providers. In the most severe, life-threatening situations, people with AECOPDs are put on a ventilator in the emergency department and admitted to the intensive care unit. Most AECOPDs can be treated with low doses of medications called steroids. This is good because high doses of steroids can cause unwanted side effects. Unfortunately, recent studies suggest that the sickest people, those admitted to the intensive care unit needing ventilator support, need higher doses of steroids because they may have resistance to these important medications. The investigators are studying steroid resistance during very severe AECOPDs so that we can eventually develop better and safer therapies for these vulnerable people.