Active clinical trials for "Acute Lung Injury"

Corona virus disease 2019 (COVID-19) has been declared as a Pandemic by the World Health Organization (WHO). According to WHO report on March 31st 2020, globally COVID-19 have infected over 750,000 people and caused over 36,000 deaths with case fatality rate of 4.85%. In Indonesia, COVID-19 have infected 1,414 people and caused 122 deaths with case fatality rate of 8.63%. In severe cases, COVID-19 causes complications, such as acute respiratory distress syndrome (ARDS), sepsis, septic shock, and multi-organ dysfunction syndrome (MODS), where age and comorbid illnesses as a major factor to these complications. Up to this point there are several promising therapies for COVID-19 but is not yet recommended and in need of further research. The use of convalescent plasma has been approved by the US Food and Drug Administration (FDA) through the scheme of emergency investigational new drug (eIND). This method has been used as the treatment in several outbreak or plague cases over the years, such as the flu epidemic in 1918, polio, measles, mumps, SARS (severe acute respiratory syndrome), EVD (Ebola virus disease) and MERS (middle-eastern respiratory syndrome) and this treatment shows better outcome. Several case report on the use of convalescent plasma for COVID-19 patients with ARDS and mechanical ventilation has been reported and shows promising outcome. Nevertheless, larger and multicenter research need to be done to assess and evaluate the effectiveness and safety of convalescent plasma therapy on for COVID-19 patients with ARDS.

This research aims to assess the use of an experimental and non-invasive procedure, Remote Ischemic Conditioning (RIC), as an adjunct therapy in attenuating severe COVID-19 disease. An excessive and counterproductive systemic inflammatory response is thought to be a major cause of severe disease and death in patients with COVID-19. Severe ICU cases frequently have markedly higher levels of inflammatory markers such as CRP, IL-6, IL and TNF-a; which is thought to be correlated with increasing disease severity. The relationship between dysregulated inflammatory processes and disease states such as acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are well understood. ALI is characterized by an acute exaggerated mononuclear/neutrophilic inflammatory response followed by progressive collagen deposition in the lung, and if severe enough, may progress to ARDS requiring ventilation.

The acute respiratory distress syndrome (ARDS) is a clinical syndrome characterized by an inflammatory pulmonary edema, severe hypoxia and endothelial and epithelial diffuse aggression. A European study estimated that this disease represents 7% of admissions to intensive care. Despite progress on the modalities of mechanical ventilation, mortality is always between 25 and 55%. The definition of this syndrome was recently amended by individualizing three sub groups based on the importance of hypoxemia (mild, moderate and severe). Achieving a bronchoalveolar lavage (BAL) by bronchoscopy remains a gold standard in the initial research of pulmonary infectious cause or secondarily face the suspicion of ventilator-associated pneumonia. Cardio pulmonary consequences of this act are not well known in patients with ARDS. The first studies on the consequences of a bronchoscopy on oxygenation of a patient breathing spontaneously have 40 years. More recent work showed a simple bronchoscopy could in the mechanically ventilated patient cause an average decrease of 26% from the base of PaO2, 10% of the mean arterial pressure (MAP) and a significant increase in cardiac output. The existence of ARDS was an independent risk factor associated with hypoxemia. A study by published in Crit Care Med in 1990 can serve as a reference in ventilated patients benefiting from BAL by bronchoscopy: in a subgroup of 26 patients, 23% of patients required an increase in the fraction of inspired oxygen (FiO2) post procedure. A study compared changes in PaO2/FiO2 after BAL with and without endoscopy among patients without (n = 23) or with pneumonia (n = 11): the decrease in PaO2/FiO2 was significant only in the "pneumonia" group. In a study of 30 patients ventilated but not hypoxic , PaO2 was still reduced by 20% 2 hours after the completion of a BAL in 40% of patients. A retrospective series of 99 ventilated patients but not hypoxic, shows that the BAL was well tolerated in accordance with a pre oxygenation procedure 15 min and by gradually decreasing the FiO 2 after the end of the procedure. BAL also appears well tolerated in a study of 12 patients ventilated under sedation and muscle relaxation, in shock and in need of positive expiratory pressure (PEEP) of at least 10 cm H2O but the authors show a decrease in PaO2 that extends well beyond the end of the intervention. Their conclusion is going to offer less invasive diagnostic techniques for patients with PaO2 less than 60 mm. No study has targeted the respiratory and hemodynamic consequences of this technique depending on the intensity of ARDS (mild, moderate or severe).

To evaluate safety and efficacy using decidual stromal cell therapy for toxicity and inflammation, with special focus on allogeneic hematopoietic cell transplantation patients. The hypothesis to be tested is that the cells are safe to infuse and that they have an anti-inflammatory and healing effect.

Acute lung injury (ALI) is caused by a wide variety of conditions, but always characterized by hypoxia and non-cardiogenic pulmonary edema. Current treatment of ALI is supportive and treatment of the underlying cause. New therapies to treat severe ALI have not been shown to improve survival, and are limited by financial and logistical resources. The investigators propose to investigate the role of inhaled sodium nitroprusside (iSNP) in ALI. Sodium nitroprusside (SNP) is a vasodilator. When inhaled, SNP may travel to areas of the lung participating in gas exchange, and cause the blood vessels surrounding these areas to enlarge. This may result in an increase of blood vessels to these areas of the lung, and improve oxygenation. Currently, iSNP has not been studied in the adult population. Therefore, this study is intended to find the safety profile of varying doses of iSNP.

Background: Lung contusion affects 17%-25% of adult blunt trauma patients, and is the leading cause of death from blunt thoracic injury. Statins are lipid-lowering drugs with recently suggested anti-inflammatory and antioxidant properties. Cyclo-oxygenase-2 (COX-2) is a key enzyme in the production of prostaglandins (PG), and evidence suggests that COX-2 plays an important role in the pathogenesis of acute lung injury (ALI). Aims: The current study aims at evaluating the beneficial effects of statins and COX-2 receptor inhibitors on ALI elicited by blunt trauma to the chest. Methods: After approval by the institutional ethics and a scientific committee, and obtaining informed consent , patients admitted to the emergency department (ED) due to blunt trauma with a diagnosis of lung contusion will be enrolled in the study.The effects of statins and COX 2 inhibitors on ALI will be assessed by recording clinical parameters and measuring inflammatory mediators levels in the serum and in the bronchoalveolar space. Expected results: The investigators expect to find that the proposed treatment will be effective in reducing ALI burden. The investigators also suppose that using a combination of those drugs will synergistically potentiate their effect on ALI.

Recruitment manoeuvres, consisting of sustained inflations at high airway pressures, have been advocated as an adjunct to mechanical ventilation in lung protective ventilation strategies to prevent the collapse of the lung. This study aims to determine the safety and efficacy of a recruitment manoeuvre, by considering its impact on gas exchange, hemodynamics and on the release of systemic inflammatory mediators.

The early initiation of Airway Pressure Release Ventilation in multi-system trauma patients decreases the incidence and severity of acute lung injury and Acute Respiratory Distress Syndrome and allows faster recovery of lung function.

An informational evaluation of COVID-19 patients who receive low-level laser therapy in addition to a normal regimen of treatment for symptoms associate with COVID-19. Results are compared to statistical observations published in literature from patients receiving standard care for COVID-19 symptoms without low-level laser therapy.

Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with Acute Lung Injury ,open label, controlled prospective study.