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ARDS clinical trials

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NCT ID: NCT04832789 Not yet recruiting - ARDS Clinical Trials

Ultra-Low Tidal Volume Mechanical Ventilation in ARDS Through ECMO

ULTIMATE
Start date: June 2021
Phase: N/A
Study type: Interventional

Primary Research Question for the Full ULTIMATE Randomized Clinical Trial (RCT): What is the effect of ultra-protective ventilation facilitated by extracorporeal membrane oxygenation (ECMO) versus best current conventional ventilation (CV) on all-cause hospital mortality among patients with early moderate-severe acute respiratory distress syndrome (ARDS)? Secondary Research Questions: Among patients with early moderate-severe ARDS, what is the effect of ultra-protective ventilation versus CV on: (1) duration of mechanical ventilation; (2) duration of ICU and hospital stay; (3) organ dysfunction; (4) barotrauma; and (5) mortality at other time-points (ICU discharge, 28-day, 60-day)? The ULTIMATE Pilot Study: Before embarking on a definitive multinational trial to address the questions listed above, the ULTIMATE Pilot Study has these 3 specific feasibility objectives: 1. To assess adherence to our explicit mechanical ventilation protocols, with particular focus on delivered tidal volumes in both groups; 2. To estimate the rate of patient recruitment and understand barriers to recruitment; and 3. To measure and understand the reasons for crossovers or rescue by ECMO in the control group. In addition, we will monitor safety issues, recording serious adverse events in both groups.

NCT ID: NCT04778228 Not yet recruiting - ARDS Clinical Trials

Driving Pressure as a Predictor of Mortality in Acute Respiratory Distress Syndrome Patients

Start date: March 1, 2021
Phase:
Study type: Observational

The aim of this study is to make analysis of potentially modifiable factors contributing to outcome of mechanically ventilated ARDS adult patient receiving lung protective strategy. Primary Objective: is to evaluate whether DP was superior to the variables that define it in predicting hospital outcome including mortality. Secondary Objective: is to identify manageable factors associated with outcome such as ventilator-related parameters and to investigate the role of non-modifiable factors such as demographic characteristics, severity of illness.

NCT ID: NCT04725110 Not yet recruiting - Covid19 Clinical Trials

Direct Topical Lung T3 Treatment to Improve Outcome & Sequelae of COVID-19 Acute Respiratory Distress Syndrome

Start date: July 1, 2024
Phase: Phase 2
Study type: Interventional

Acute treatment of COVID-ARDS with direct topical lung instilled T3 therapy for patients on mechanical ventilation.

NCT ID: NCT04530188 Not yet recruiting - ARDS Clinical Trials

Effects of Sevoflurane on Extravascular Lung Water and Pulmonary Vascular Permeability in Patients With ARDS

Start date: November 2020
Phase: Phase 3
Study type: Interventional

The study will investigate the effects of inhaled sedation with sevoflurane using the AnaConDa device on extravascular lung water index (EVLWi) and the pulmonary vascular permeability index (PVPI) in patients with moderate to severe acute respiratory distress syndrome (ARDS). Improvement in oxygenation and decreases in lung inflammatory response has been demonstrated in patients with ARDS compared with intravenous sedation. However, preclinical data showing a decrease in lung edema has not been confirmed. The hypothesis is that inhaled sedation with sevoflurane reduces EVLWi and PVPI in patients with ARDS, assessed with the PiCCO device. Patients will receive either inhaled sedation (interventional group), or a sedation with propofol (control group). Both will be associated with remifentanil. Sedation will be monitored by bispectral index with a targeted value of 30-50. The primary outcome will be daily assessment of EVLWi and PVPI over time in patients sedated with sevoflurane compared to propofol. Secondary outcomes will include value of PVPI and EVLW at 48h after intubation, fluid administration, need in norepinephrine, time between cessation of sedation and trial of weaning sedation, ventilation free days, mortality at day 28, the partial pressure of arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2), plasma and alveolar levels of cytokines (tumor necrosis factor (TNF)-α, interleukine (IL)-1β, IL-6, IL-8). These blood and alveolar samples will be done at baseline, on day 2 and on day 5. A sub-group analysis will be done in Covid-19 related ARDS. Decrease in PVPI and EVLWi with inhaled sevoflurane may be related to the decrease in lung edema in ARDS patients and may ultimately improve patient outcome.

NCT ID: NCT04452097 Not yet recruiting - COVID-19 Clinical Trials

Use of hUC-MSC Product (BX-U001) for the Treatment of COVID-19 With ARDS

Start date: July 1, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase 1/2a study including 2 parts, phase 1 and phase 2a. The phase 1 part is an open-label, single-arm, dose-escalating study to evaluate the safety and explore the dose limiting toxicity and maximum tolerated dose of a human umbilical cord derived mesenchymal stem cell product (BX-U001) in severe COVID-19 pneumonia patients with acute respiratory distress syndrome (ARDS). Qualified subjects after the screening will be divided into low, medium, or high dose groups to receive a single intravenous infusion of BX-U001 at the dose of 0.5×10^6, 1.0×10^6, or 1.5×10^6 cells/kg of body weight, respectively. The Phase 2a part is a randomized, placebo-controlled, double-blind clinical trial examining the safety and biological effects of BX-U001 at the appropriate dose selected from phase 1 for severe COVID-19 pneumonia patients with the same inclusion/exclusion criteria as the phase 1 part.

NCT ID: NCT04377334 Not yet recruiting - COVID-19 Clinical Trials

Mesenchymal Stem Cells (MSCs) in Inflammation-Resolution Programs of Coronavirus Disease 2019 (COVID-19) Induced Acute Respiratory Distress Syndrome (ARDS)

Start date: May 2022
Phase: Phase 2
Study type: Interventional

To evaluate the safety, toxicity and immunological effects of infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells (MSCs) and whether this therapy has an influence on the resolution processes in ARDS patients infected with Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

NCT ID: NCT04366115 Not yet recruiting - Covid19 Clinical Trials

Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS

AVM0703
Start date: December 1, 2022
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blinded, placebo-controlled study of AVM0703 administered as a single intravenous (IV) infusion to patients with moderate or severe immediately life-threatening Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 or influenza (A or B). The study is designed to evaluate the safety, tolerability, and pharmacokinetics of single dose of AVM0703 in these ARDS patients.

NCT ID: NCT03245684 Not yet recruiting - ARDS Clinical Trials

Assisted or Controlled Ventilation in Ards (Ascovent)

ASCOVENT
Start date: September 1, 2017
Phase: N/A
Study type: Interventional

The present pilot randomized controlled clinical trial will test the hypothesis that in patients with ARDS, fixing ventilator settings to the conventional protective ventilatory strategy (VT 6 ml/kg ideal body weight and Pplat ≤ 30 cmH2O, PEEP according the PEEP/FiO2 table), control modes of mechanical ventilation will be associated to a concentration of pulmonary and systemic inflammatory mediators lower than the concentration of inflammatory mediators observed during assisted modes of mechanical ventilation.

NCT ID: NCT02958748 Not yet recruiting - ARDS Clinical Trials

Change of Immune Cell of ARDS Patients:an Observational Study

Start date: November 2016
Phase: N/A
Study type: Observational

To evaluate change of different immune cellsduring ARDS and its impact on prognosis.

NCT ID: NCT02510105 Not yet recruiting - ARDS Clinical Trials

Tomodensitometric Study of Pulmonary Effects of Intrapulmonary Percussive Ventilation in ARDS Patients

PERVE-ARDS
Start date: July 2015
Phase: N/A
Study type: Interventional

The study is intended to elucidate the pulmonary effects of Intrapulmonary Percussive Ventilation (IPV) with VDR4 ventilator of patients with ARDS, using computed tomography (CT).