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ARDS, Human clinical trials

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NCT ID: NCT06224010 Completed - Clinical trials for Mechanical Ventilation Complication

Respiratory Drive and Inspiratory Effort in COVID-19 Associated ARDS

Start date: November 21, 2020
Phase:
Study type: Observational

Data comparing respiratory drive and effort in critically ill patients with acute respiratory distress syndrome associated to different severity of COVID-19 penumonia (CARDS) and to other risk factors are lacking. Objectives: To assess respiratory drive and effort of CARDS patients at the first transition from controlled to assisted spontaneous breathing. The second aim was the rate of a composite outcome including the need of higher level of sedation

NCT ID: NCT06197256 Completed - COVID-19 Clinical Trials

Cardiac Dysfunction in Critically Ill Covid-19 Patients

Start date: May 7, 2020
Phase:
Study type: Observational

We conducted an observation sub-study of the prospective randomized controlled trial "High Dose Inhaled Nitric Oxide in Acute Hypoxemic Respiratory Failure", in which we analysed the echocardiographic data collected both at baseline when patients where included and 3-5 days later for followup.

NCT ID: NCT05693051 Completed - ARDS, Human Clinical Trials

Use of Prone Position Ventilation in Danish Patients With COVID-19 Induced Severe ARDS Treated With VV-ECMO

Start date: October 1, 2020
Phase:
Study type: Observational

Prone position ventilation was used 220 times in 44 out of 68 patients with severe COVID-19 induced ARDS treated with VV-ECMO. PPV treated patients did not benefit from PPV and the incidence of PPV related adverse events was high

NCT ID: NCT05442073 Completed - ARDS, Human Clinical Trials

Effect of Initial Empirical PEEP Setting on the Esophageal Pressure-guided PEEP Titration in ARDS

Start date: March 1, 2022
Phase:
Study type: Observational [Patient Registry]

Esophageal manometry was used as surrogate of pleural pressure to titrate positive end-expiratory pressure (PEEP) in ARDS patients. However, Absolute values of esophageal pressure (Pes) could be affected by the PEEP setting. In moderate to severe ARDS patients, the end-expiratory Pes changed differently with PEEP adjustment. and the esophageal phenotypes could be divided into type I and type II. with Type I (ΔPes≥30%ΔPEEP)and Type II(ΔPes<30%ΔPEEP).

NCT ID: NCT05426746 Completed - ARDS, Human Clinical Trials

First-In-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALT-100

Start date: July 5, 2022
Phase: Phase 1
Study type: Interventional

ALT-100 is a monoclonal antibody developed by Aqualung Therapeutics Corp. as a treatment for Acute Respiratory Distress Syndrome (ARDS). ARDS can occur as a serious complication in patients with respiratory infections such as COVID-19 and Influenza or have acquired trauma to their lungs. 32 healthy male or female participants between the ages of 18 and 55 years will be enrolled into 4 cohorts of single ascending doses. The doses being investigated are 0.1mg/kg, 0.4mg/kg, 1mg/kg and 4mg/kg administered by intravenous infusion. Participants will be screened within 28 days of study treatment, be admitted to the clinical research unit for 3 nights and attend 7 outpatient visits on study days 8, 15, 22, 29, 60, 90 and 120 respectively. This study will collect data to evaluate safety and tolerability, Pharmacokinetics of ALT-100, Pharmacodynamics of ALT-100 and determine if Anti-drug Antibodies are produced in the participants.

NCT ID: NCT05394961 Completed - COVID-19 Clinical Trials

Factors Associated With Decisions to Withhold or Withdraw Intensive Care

Start date: August 26, 2021
Phase:
Study type: Observational

Medical and socioeconomic data are extracted from the Swedish Intensive Care Registry (SIR), the Swedish National Patient Registry and Statistics Sweden for all adult patients admitted to in Swedish intensive care units between 2014-01-01 and 2020-12-31 with a diagnosis of sepsis and/or acute respiratory distress syndrome (ARDS) and/or coronavirus 19 (COVID-19) infection, and registered in SIR. The impact of demographic and socioeconomic factors on decisions to withhold or withdraw intensive care, and on mortality, are studied and statistically adjusted for level of chronic comorbidity and severity of acute illness.

NCT ID: NCT04901338 Completed - Septic Shock Clinical Trials

Cytokine Hemoadsorption in ECMO Patients

Start date: June 1, 2017
Phase:
Study type: Observational

Cytokine hemoadsorption is a novel therapy used to improve outcome in critically ill patients with a dysregulated cytokine response and hemodynamic instability. Patients on extracorporeal membraneous oxygenation (ECMO) often develop severe systemic inflammatory response syndrome (SIRS). Cytokine removal using different types of hemoadsorption devices is believed to block the vicious circle of inflammation dysregulation when other basic therapeutic measures fail. To date there are very limited reports on ECMO and cytokine hemoadsorption combination therapy. The aim of this retrospective study is to evaluate feasibility and effectiveness of hemoadsorption in veno-arterial and veno-venous ECMO patients.

NCT ID: NCT04729075 Completed - Covid19 Clinical Trials

Associations Between COVID-19 ARDS Treatment, Clinical Trajectories and Liberation From Mechanical Ventilator - an Analysis of the NorthCARDS Dataset

NorthCARDS
Start date: January 19, 2021
Phase:
Study type: Observational [Patient Registry]

The mortality rates associated with COVID-19 related ARDS (COVIDARDS) have varied from observational reports from around the world. This has ranged from 44% (28 day mortality) in the UK to 36% (28 day mortality from ICU admission) in Italian studies, to 32% (all-cause 28 day mortality) in Spain. Predictive models have identified risk factors for COVID-19 hospitalized patients' mortality to include male sex, obesity, age, obesity, comorbidities including chronic lung disease and hypertension, as well as biomarkers including high levels of D-Dimer, LDH and CRP. In addition, practice patterns, such as drugs that were administered, timing of mechanical ventilation and adherence to established lung protective ventilation protocols are known to be variable across sites and have changed over time. The investigators propose to analyze outcomes for patients with COVIDARDS within the NorthCARDS dataset (a dataset of over 1500 patients with COVID-19 related ARDS across the Northwell Health System in the NYC metropolitan region and Long Island, NY) to understand differences in hospital survival and in the time to liberation from mechanical ventilation, specifically looking at the associations between baseline patient factors, changes in biomarkers, respiratory function and hemodynamics over time, and treatments administered. The analyses will be based on three hypotheses: H.1. Worsening trajectories of: oxygenation index (OI), respiratory system compliance (C), and inflammatory markers will be associated with lower hospital survival. H.2. Higher duration of deep sedation and paralytics will be associated with greater time to liberation from mechanical ventilation. This risk will be increased in patients with worsening trajectories of OI, C, and inflammatory markers over time. H.3. Type of mechanical ventilator, specifically the time on portable mechanical ventilator, is associated with hospital mortality and with inability to liberate from mechanical ventilator despite controlling for risk factors of changes in OI, C and Inflammatory markers over time, and the use of paralytics and deep sedation.

NCT ID: NCT04719182 Completed - Covid19 Clinical Trials

Practice of Adjunctive Treatments in Intensive Care Unit Patients With COVID-19

PRoAcT-COVID
Start date: September 1, 2020
Phase:
Study type: Observational

Rationale Many patients with coronavirus disease (COVID-19) need hospital admission for oxygen supplementation. A substantial number of patients need intensive care unit (ICU) admission for escalation of care. ICU doctors and nurses are struggling to provide the best care for patients with COVID-19. Practice of adjunctive and supportive treatments remains uncertain. Objective To determine and compare practice of adjunctive and supportive treatments for COVID-19 in the Netherlands, and to determine their independent associations with outcome. Hypotheses Practice of adjunctive and supportive treatments for COVID-19 varies substantially. Adjunctive and supportive treatments have an independent association with outcome in ICU patients with COVID-19. Study design National/international, multicenter, retrospective observational study. Study population Intensive care unit (ICU) patients with COVID-19. Methods In this study we will collect data on diverse treatments during the first 28 days in ICU, including (a) the types of oxygen support* and awake prone positioning; (b) the types of ventilatory support, (c) rescue therapies for refractory hypoxemia during invasive ventilation (prone positioning, ventilator adjustments, continuous muscle paralysis, and extracorporeal membrane oxygenation); (d) adjunctive treatments, including thromboprophylaxis and anticoagulation, antiviral and immunomodulating therapies, and (e) experimental supportive treatments. Outcomes include duration of each adjunctive treatment, duration of ventilation, incidence of tracheostomy, duration of stay in ICU and mortality until day 90. Study endpoints A combination of adjunctive treatments, including types of oxygen support, ventilatory support and rescue therapies for refractory hypoxemia during invasive ventilation (primary), other adjunctive and supportive treatments, tracheostomy rate; duration of ventilation and ventilator-free days and alive at day 28 (VFD-28), duration of ICU and hospital stay, and ICU, hospital and 90-day mortality. Nature and extent of the burden and risks associated with participation, benefit and group relatedness Retrospective collection of data regarding adjunctive treatments, and clinical endpoints is without risk for ICU patients. *In a subset of patients we will collect granular data (every two hours) regarding oxygenation (FiO2, inspiratory tidal volume, air flow, respiratory rate, SpO2, PaO2, and PEEP) over the first 2 full calendar days of ICU admission. The primary endpoint of this sub-analysis will be the amount of oxygen used with different respiratory support interventions. The statistical analysis plan for the analysis of these data that were collected in two ICUs that participated in the national study, and one additional ICU in Spain is uploaded in the document section (filename Statistical Analysis Plan PROXY-COVID)

NCT ID: NCT04612608 Completed - ARDS, Human Clinical Trials

Assessing the Role of Inclined Positioning in Acute Respiratory Distress Syndrome Patients Recovery

ARISE
Start date: May 26, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effect of intermittent, nearly vertical, patient positioning in a specialized upright bed, on outcomes of mechanically ventilated patients with acute respiratory distress syndrome (ARDS) who are in the ICU.