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Acute Lung Injury clinical trials

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NCT ID: NCT04597853 Recruiting - Covid19 Clinical Trials

Assessment of Lung Mechanics in COVID-19 Acute Respiratory Distress Syndrome

LungMechCoV-19
Start date: March 1, 2021
Phase:
Study type: Observational

This study is meant to assess the lung mechanics in SARS-CoV-2 induced acute respiratory failure. A precise characterisation of lung mechanics and heart-lung-interactions might allow a better understanding of SARS-CoV-2 induced acute respiratory failure and thus lead to better mechanical ventilation strategies. This monocentric, observational study of critically ill COVID-19 patients in the ICU, will employ impedance tomography, right-heart catheterization, oesophageal pressure measurements, indirect calorimetry as well as classic mechanical ventilation parameters to characterise the mechanical characteristics of the lung as well as the heart-lung interactions in SARS-CoV-2 induced acute respiratory failure.

NCT ID: NCT04565665 Recruiting - Clinical trials for Malignant Solid Neoplasm

Cord Blood-Derived Mesenchymal Stem Cells for the Treatment of COVID-19 Related Acute Respiratory Distress Syndrome

Start date: July 29, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I trial followed by a phase II randomized trial. The purpose of phase I study is the feasibility of treating patients with acute respiratory distress syndrome (ARDS) related to COVID-19 infection (COVID-19) with cord blood-derived mesenchymal stem cells (MSC). The purpose of the phase II trial is to compare the effect of MSC with standard of care in these patients. MSCs are a type of stem cells that can be taken from umbilical cord blood and grown into many different cell types that can be used to treat cancer and other diseases. The MSCs being used for infusion in this trial are collected from healthy, unrelated donors and are stored and grown in a laboratory. Giving MSC infusions may help control the symptoms of COVID-19 related ARDS.

NCT ID: NCT04546919 Recruiting - Clinical trials for Acute Respiratory Distress Syndrome (ARDS)

Effect of R-spondin3 on Sepsis Induced Endothelial Dysfunction

Start date: July 8, 2020
Phase:
Study type: Observational

Sepsis is the most frequent risk factor for ALI/ARDS. Meanwhile, Pulmonary is the most vulnerable organ to fail in response to sepsis, vascular endothelial dysfunction is a central event in the pathophysiology of sepsis. An improved understanding of endothelial response and associated biomarkers may lead to strategies to more accurately predict outcome and develop novel endothelium-directed therapies in sepsis. The human and mouse R-spondins encode a family of proteins that includes four paralogs (R-spo1-4). R-spondins are secreted proteins found primarily in the extracellular region and are known to promote β-catenin signaling. Among them, the embryonic lethal vascular remodeling phenotype of R-spondin3 (Rspo3) mutant mice suggests a role of EC derived Rspo3 in angiogenesis. Rspo3 protects tissues against mesenteric I/R by tightening endothelial cell junction and improving vascular intergrity. However, the role of Rspo3 in sepsis-induced pulmonary endothelial dysfunction remains unclear. Thus, it is worthwhile to explore the relationship between Rspo3 and sepsis-induced lung injury, which will be helpful for prevention and treatment of sepsis-induced lung injury and endothelial dysfunction.

NCT ID: NCT04545424 Recruiting - Clinical trials for Respiratory Distress Syndrome, Adult

Trial of Therapeutic Hypothermia in Patients With ARDS

CHILL
Start date: June 29, 2021
Phase: Phase 2
Study type: Interventional

Acute Respiratory Distress Syndrome (ARDS) is a serious condition that occurs as a complication of medical and surgical diseases, has a mortality of ~40%, and has no known treatment other than optimization of support. Data from basic research, animal models, and retrospective studies, case series, and small prospective studies suggest that therapeutic hypothermia (TH) similar to that used for cardiac arrest may be lung protective in patients with ARDS; however, shivering is a major complication of TH, often requiring paralysis with neuromuscular blocking agents (NMBA) to control. Since the recently completed NHLBI PETAL ROSE trial showed that NMBA had no effect (good or bad) in patients with moderate to severe ARDS, the CHILL trial is designed to evaluate whether TH combined with NMBA is beneficial in patients with ARDS. This Phase IIb randomized clinical trial is funded by the Department of Defense to compare TH (core temperature 34-35°C) + NMBA for 48h vs. usual temperature management in patients in 14 clinical centers with the Clinical Coordination Center and Data Coordinating Center at University of Maryland Baltimore. Planned enrollment is 340 over ~3.5 years of the 4-year contract. COVID-19 is considered an ARDS risk-factor and patients with ARDS secondary to COVID-19 pneumonia will be eligible for enrollment. Primary outcome is 28-day ventilator-free days. Secondary outcomes include safety, physiologic measures, mortality, hospital and ICU length of stay, and serum biomarkers collected at baseline and on days 1, 2, 3, 4, and 7.

NCT ID: NCT04541264 Recruiting - Clinical trials for Early Prediction for Sepsis Induced Acute Lung Injury

Radiomics Markers to Predict Sepsis Induced Acute Respiratory Distress Syndrome

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

Introduction: Sepsis-induced acute respiratory distress syndrome(SI-ARDS) is a common complication of severe sepsis and is an independent contributor to poor prognosis of patients. It remains a clinical challenge to identify the SI-ARDS early and accurately, which could optimize the treatment strategy and reduce the mortality risk. Radiomics high-dimensional features extracted from CT images offer an insight into microvascular damage of SI-ARDS that are imperceptible to human eyes and aspects of intra-alveolar heterogeneity with potential prognostic relevance. Methods: Study design Investigators screened all patients with sepsis and septic shock who are treated in Sun Yat-sen Memorial Hospital, Sun Yat-sen University during the period from 1 May 2015 and 30 May 2022. Patients were recruited retrospectively from May 2015 to April 2021 as discovering group, and prospectively during the period from May 2021 to May 2022 as validation group. Follow-up will conducted until April 2023. Cohort descriptions and definitions Investigators plan to recruit 160 patients in discovering group, 40 patients in internal validation group, and 100 patients in external validation group. Patients between 18 and 80 years of age with sepsis and septic shock will be screened for eligibility. SI-ARDS is defined by sequential occurrence of the sepsis-3 consensus criteria for sepsis and the Berlin Definition for ARDS. The exclusion criteria are: 1. admission stay <24hours, 2. the presence of end-stage lung disease or long-term oxygen therapy, 3. critically ill patients who have started mechanical ventilation caused by SI-ARDS before admission, 4. a history of lung transplantation and chronic obstructive pulmonary disease, 5. cancer patients not/have received chemotherapy. Outcome measures In this study, the primary outcome measure was the occurrence rates of acute respiratory distress syndrome(ARDS). It refers to the occurrence of sepsis patients progressed into ARDS. Secondary outcome measures were as follows: 1.28-day mortality 2.ventilator-free days 3.respiratory failure-free days Data collection All clinical data were collected by investigators and trained personnel. Each participant's data will be filled in electronic case report forms (CRF) and store online using REDCap (Research Electronic Data Capture). Discussion: SI-ARDS is one common severe complication with critically ill sepsis patients, which causes high mortality and poor prognosis. Early ARDS patient(arterial oxygen tension/inspired oxygen fraction [PaO2/FIO2] ≤ 300 mmHg but > 200 mmHg) may not require invasive mechanical ventilation, and is more readily reversible than acute respiratory distress syndrome(ARDS). In this ambispecive cohort study, investigators developed and validated novel nomograms incorporating the radiomics signature and clinical signature to provide an easy-to-use and individualized prediction of SI-ARDS occurrence and severe degree in patients with early stage.

NCT ID: NCT04525378 Recruiting - Covid19 Clinical Trials

MSC-based Therapy in COVID-19-associated Acute Respiratory Distress Syndrome

Start date: July 1, 2020
Phase: Phase 1
Study type: Interventional

Considering the potential of mesenchymal stromal cells (MSCs) in the treatment of lung injuries by COVID-19, this pilot clinical trial evaluates the safety and potential efficacy of the cell therapy, administered intravenously, in patients with pneumonia associated with COVID-19-associated acute respiratory distress syndrome.

NCT ID: NCT04524091 Recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Inspiratory Ratio: Predictor of Inspiratory Effort Response to High PEEP in Patients Recovering From ARDS

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

Spontaneous Breathing (SB) can be potentially harmful in patient with Acute Respiratory Distress Syndrome (ARDS) during the transition phase of passive ventilation to partial ventilatory support. The application of high Positive End Expiratory Pressure (PEEP) during SB has shown to ameliorate the progression of lung injury by decreasing the TP and esophageal pressure (EP) swings and the stress / strain applied to the lung. The mechanisms proposed to be responsible for these effects are the activation of Hering Breuer reflex, the recruitment of previously collapsed tissue, the homogenization of lung and the improvement of respiratory system compliance and the impairment in the length - tension relationship of the diaphragm. If all the previously explained mechanisms have an effect on the control of inspiratory effort, a decrease in the intensity of effort is expected during an end-inspiratory occlusion in patients who will respond to high PEEP application. Based on this rationale, the investigators developed an index called "Inspiratory Ratio" (IR) to predict the response of patient's inspiratory effort to the application of high PEEP without need of esophageal manometry.

NCT ID: NCT04520815 Recruiting - Clinical trials for Respiratory Distress Syndrome, Adult

Prevalence and Kinetics of Diaphragmatic Dysfunction in Elderly Patients With Acute Respiratory Distress

OLDIA
Start date: June 24, 2020
Phase:
Study type: Observational

Acute respiratory distress (ARD) is one of the most frequent reasons for consultation and hospitalization in emergency medicine. The use of ultrasound methods as a diagnostic and clinical assessment tool in emergency medicine is increasingly important. As such, ultrasound is a simple, non-invasive means of assessing diaphragmatic function in the patient's bed. Several methods of ultrasound assessment of diaphragm function have been described. Among these different methods, the diaphragmatic excursion seems to have a better intra and interobserver reproducibility as well as a greater feasibility, in particular because of its speed of realization and its learning curve seeming faster in comparison with the measurement. of the thickening fraction. Measuring the diaphragmatic excursion could therefore ultimately represent a simple means of assessing respiratory function, both diagnostic and prognostic, in patients with acute respiratory distress in the emergency departments. The etiologies of acute respiratory distress in very elderly patients (i.e.> 75 years) admitted to the emergency reception service are multiple. To our knowledge, there is no data available in the literature on the prevalence of diaphragmatic dysfunction and its short- and long-term course in this category of patients. The main objective of this study is therefore to assess the prevalence of diaphragmatic dysfunction and its evolutionary kinetics in patients over the age of 75 admitted for acute respiratory distress in the emergency medicine department.

NCT ID: NCT04511923 Recruiting - Covid19 Clinical Trials

Nebulised Heparin to Reduce COVID-19 Induced Acute Lung Injury

CHARTER-Irl
Start date: December 23, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The investigators present a randomised open label phase Ib/IIa trial of nebulised unfractionated heparin to evaluate the effect of nebulised unfractionated heparin on the procoagulant response in ICU patients with SARS-CoV-2 requiring advanced respiratory support. As this is one of the first studies of nebulised heparin in COVID 19 lung disease the investigators will assess safety as a co-primary outcome.

NCT ID: NCT04503876 Recruiting - ARDS Clinical Trials

Effects of End-expiratory Positive Pressure Optimization in Intubated Patients With Healthy Lung or Acute Respiratory Distress Syndrome

PEEP-Réa
Start date: September 12, 2019
Phase: N/A
Study type: Interventional

PEEP titration is a recommended during invasive mechanical ventilation of ICU patients. However, little is known about the right way to conduct this titration. PEEP titration can be conducted by a stepwise increase in PEEP level, or following an ARM and a consecutive stepwise decrease in PEEP level. Those 2 methods will be explored in intubated ICU patients either with healthy lung or ARDS lungs. Physiological exploration will include end-expiratory lung volume measurements, driving pressure, compliance and electro-impedance tomography at each PEEP level.