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Lung Injury clinical trials

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NCT ID: NCT05289570 Terminated - Acute Lung Injury Clinical Trials

Voxelotor for Improving Oxygen Saturation in Adults

Voxelotor
Start date: May 3, 2022
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the efficacy of voxelotor for increasing oxygen saturation in 20 patients with hypoxemia. Specifically, the SpO2/FiO2 ratio will be compared before and after voxelotor use at rest and during exercise (ambulatory patients only). The primary study objective is to evaluate the efficacy of voxelotor for increasing oxygen saturation in patients with hypoxic hypoxemia as a result of end-stage lung disease or acute lung injury. The secondary objective is to evaluate the efficacy of voxelotor on allowing de-escalation of supplemental oxygen support.

NCT ID: NCT04526912 Terminated - Acute Lung Injury Clinical Trials

Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection

ALI
Start date: August 28, 2020
Phase: Phase 1
Study type: Interventional

The study aims to assess the potential benefit and evaluate the safety and tolerability of a single subcutaneous (SC) dose of VIB7734 in hospitalized patients with documented infection of severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) with pulmonary involvement. Subjects will be administered a single dose of VIB7734 injected under the skin, assessed for efficacy for 28 days and followed for an additional 42 days.

NCT ID: NCT04434001 Terminated - Clinical trials for Congenital Heart Disease

ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac Surgery

ZEPLAST-PED
Start date: February 27, 2020
Phase: Phase 2
Study type: Interventional

In pediatric patients (newborns and infants weighing less than 10 kg) undergoing cardiac surgery with extracorporeal circulation postoperative bleeding represents a known complication with a significant impact on outcome. Fresh frozen plasma (FFP) for bleeding management is associated, particularly in this kind of patients, to volume overload and a significative increase of Transfusion Related Acute Lung Injury (TRALI), further worsening the postoperative outcome. In the adult patient FFP employment could be almost completely canceled by administration of concentrated hemostatic components - the fibrinogen concentrate and prothrombin complex concentrate (PCC). We designed this phase II pilot study to establish whether an analogous strategy, modified accordingly to pediatric physiology, could be safely and successfully applied in newborns and infants.

NCT ID: NCT04397510 Terminated - Covid-19 Clinical Trials

Nebulized Heparin for the Treatment of COVID-19 Induced Lung Injury

Start date: June 1, 2020
Phase: Phase 4
Study type: Interventional

Randomized, placebo controlled study to determine if nebulized heparin may reduce the severity of lung injury caused by the novel coronavirus, also known as COVID-19

NCT ID: NCT04389840 Terminated - Acute Lung Injury Clinical Trials

Dociparstat for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure

Start date: July 8, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This was a randomized, double-blind, placebo-controlled Phase 2/3 study to evaluate the safety and efficacy of dociparstat sodium in adult patients with acute lung injury (ALI) due to Coronavirus Disease 2019 (COVID-19). This study was designed to determine if dociparstat sodium could accelerate recovery and prevent progression to mechanical ventilation in patients severely affected by COVID-19.

NCT ID: NCT04369469 Terminated - Clinical trials for Acute Respiratory Distress Syndrome

Efficacy and Safety Study of IV Ravulizumab in Patients With COVID-19 Severe Pneumonia

Start date: May 10, 2020
Phase: Phase 3
Study type: Interventional

This study evaluated the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult participants with coronavirus disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome. Participants were randomly assigned to receive ravulizumab in addition to best supportive care (BSC) (2/3 of the participants) or BSC alone (1/3 of the participants). BSC consisted of medical treatment and/or medical interventions per routine hospital practice.

NCT ID: NCT04360096 Terminated - COVID Clinical Trials

Inhaled ZYESAMI™ (Aviptadil Acetate) for the Treatment of Severe COVID-19

AVICOVID-2
Start date: February 15, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Brief Summary: SARS-CoV-2 virus infection is known to cause Lung Injury that begins as dyspnea and exercise intolerance, but may rapidly progress to Critical COVID-19 with Respiratory Failure and the need for noninvasive or mechanical ventilation. Mortality rates as high as 80% have been reported among those who require mechanical ventilation, despite best available intensive care. Patients with severe COVID-19 by FDA definition who have not developed respiratory failure be treated with nebulized ZYESAMI™ (aviptadil acetate, a synthetic version of Vasoactive Intestinal Polypeptide (VIP)) 100 μg 3x daily plus Standard of Care vs. placebo + Standard of Care using an FDA 501(k) cleared mesh nebulizer. The primary outcome will be progression in severity of COVID-19 (i.e. critical OR severe progressing to critical) over 28 days. Secondary outcomes will include blood oxygenation as measured by pulse oximetry, dyspnea, exercise tolerance, and levels of TNFα IL-6 and other cytokines.

NCT ID: NCT03951064 Terminated - Respiratory Failure Clinical Trials

Providing Optimal PEEP During Mechanical Ventilation for Obese Patients Using Esophageal Balloon

PROP OPEN
Start date: March 31, 2021
Phase: N/A
Study type: Interventional

This is a research study to determine if identifying an optimal level of positive end-expiratory pressure (PEEP) targeted specifically to individualized patient characteristics will shorten the time on the ventilator. Participants will have catheter placed through the nose into the esophagus to measure the pressure inside the chest. This catheter will remain until the patient is freed from the ventilator. Participants will be randomized to usual care or to have the level of PEEP determined by the esophageal balloon pressure readings. The total time spent on the ventilator will be recorded.

NCT ID: NCT03902509 Terminated - Clinical trials for Radiation-induced Lung Injury

A Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.

Start date: May 24, 2019
Phase: Phase 2
Study type: Interventional

Using Pirfenidone to treat Grade 2 or Grade3 radiation-induced lung injury, and observe the efficacy and safety of the drug.

NCT ID: NCT03525691 Terminated - ARDS, Human Clinical Trials

Enhanced Lung Protective Ventilation With ECCO2R During ARDS

PROVE
Start date: May 23, 2018
Phase: N/A
Study type: Interventional

Acute Respiratory Distress Syndrome (ARDS) is associated with a mortality rate of 30 - 45 % and required invasive mechanical ventilation (MV) in almost 85 % of patients[1]. During controlled MV, driving pressure (i.e., the difference between end-inspiratory and end-expiratory airway pressure) depends of both tidal volume and respiratory system compliance. Either excessive tidal volume or reduced lung aeration may increase the driving pressure. ARDS patients receiving tidal volume of 6 ml/kg predicted body weight (PBW) and having a day-1 driving pressure ≥ 14 cmH2O have an increased risk of death in the hospital[2]. Seemly, in the LUNG SAFE observational cohort, ARDS patients having a day-1 driving pressure < 11 cmH2O had the lowest risk of death in the hospital[1]. Hence, driving pressure acts as a major contributor of mortality in ARDS, and probably reflects excessive regional lung distension resulting in pro-inflammatory and fibrotic biological processes. Whether decreasing the driving pressure by an intervention change mortality remains an hypothesis; but one of means is to decrease the tidal volume from 6 to 4 ml/ kg predicted body weight (PBW). However, this strategy promotes hypercarbia, at constant respiratory rate, by decreasing the alveolar ventilation. In this setting, implementing an extracorporeal CO2 removal (ECCO2R) therapy prevents from hypercarbia. A number of low-flow ECCO2R devices are now available and some of those use renal replacement therapy (RRT) platform. The investigators previously reported that combining a membrane oxygenator (0.65 m²) within a hemofiltration circuit provides efficacious low flow ECCO2R and blood purification in patients presenting with both ARDS and Acute Kidney injury[3]. This study aims to investigate the efficacy of an original ECCO2R system combining a 0.67 m² membrane oxygenator (Lilliput 2, SORIN) inserted within a specific circuit (HP-X, BAXTER) and mounted on a RRT monitor (PrismafleX, BAXTER). Such a therapy only aims to provide decarboxylation but not blood purification and has the huge advantage to be potentially implemented in most ICUs without requiring a specific ECCO2R device. The study will consist in three periods: - The first period will address the efficacy of this original ECCO2R system at tidal volume of 6 and 4 ml/kg PBW using an off-on-off design. - The second part will investigate the effect of varying the sweep gas flow (0-2-4-6-8-10 l/min) and the mixture of the sweep gas (Air/O2) on the CO2 removal rate. - The third part will compare three ventilatory strategies applied in a crossover design: 1. Minimal distension: Tidal volume 4 ml/kg PBW and positive end-expiratory pressure (PEEP) based on the ARDSNet PEEP/FiO2 table (ARMA). 2. Maximal recruitment: 4 ml/kg PBW and PEEP adjusted to maintain a plateau pressure between 23 - 25 cmH2O. 3. Standard: Tidal volume 6 ml/kg and PEEP based on the ARDSNet PEEP/FiO2 table (ARMA).