Acute Respiratory Distress Syndrome Clinical Trial
Official title:
A Phase 1 Study: The Determination of the Maximum Tolerable Dosage of Nebulized Sodium Nitroprusside in Adult Acute Lung Injury
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.
Acute lung injury (ALI) is a syndrome characterized by acute hypoxemic respiratory failure
with bilateral pulmonary infiltrates that are not attributed to left atrial hypertension.
ALI is responsible for significant mortality and morbidity in the critically ill population.
Novel rescue therapies used to support oxygenation in severe ALI include inhaled nitric
oxide and high frequency oscillatory ventilation; however, neither have been shown to reduce
mortality and both are limited by logistical and financial challenges.
Inhaled sodium nitroprusside (iSNP) is a vasodilator which causes local vasodilation of
pulmonary capillaries surrounding functional alveoli, resulting in improved oxygenation by
redistributing pulmonary blood flow to areas with better ventilation-perfusion ratios. As
iSNP can be administered by a low-cost nebulizer and is relatively inexpensive compared to
other novel rescue therapies, this modality may be an alternative therapy for patients with
severe hypoxemia. Two pediatric studies support the use of iSNP in ALI; however, iSNP has
not been studied in the adult ALI population. To determine whether iSNP can improve
oxygenation in adult ALI, the maximum tolerable dose (MTD) must first be determined.
Our study aims to determine the MTD of iSNP in adult ALI through an open-label,
non-randomized, single centered, dose escalation study design, whereby subjects will receive
iSNP for thirty minutes and have various physiologic variables recorded.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05535543 -
Change in the Phase III Slope of the Volumetric Capnography by Prone Positioning in Acute Respiratory Distress Syndrome
|
||
| Completed |
NCT04695392 -
Restore Resilience in Critically Ill Children
|
N/A | |
| Terminated |
NCT04972318 -
Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia
|
N/A | |
| Completed |
NCT04534569 -
Expert Panel Statement for the Respiratory Management of COVID-19 Related Acute Respiratory Failure (C-ARF)
|
||
| Completed |
NCT04078984 -
Driving Pressure as a Predictor of Mechanical Ventilation Weaning Time on Post-ARDS Patients in Pressure Support Ventilation.
|
||
| Completed |
NCT04451291 -
Study of Decidual Stromal Cells to Treat COVID-19 Respiratory Failure
|
N/A | |
| Not yet recruiting |
NCT06254313 -
The Role of Cxcr4Hi neutrOPhils in InflueNza
|
||
| Not yet recruiting |
NCT04798716 -
The Use of Exosomes for the Treatment of Acute Respiratory Distress Syndrome or Novel Coronavirus Pneumonia Caused by COVID-19
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT04909879 -
Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome
|
Phase 2 | |
| Terminated |
NCT02867228 -
Noninvasive Estimation of Work of Breathing
|
N/A | |
| Not yet recruiting |
NCT02881385 -
Effects on Respiratory Patterns and Patient-ventilator Synchrony Using Pressure Support Ventilation
|
N/A | |
| Completed |
NCT02545621 -
A Role for RAGE/TXNIP/Inflammasome Axis in Alveolar Macrophage Activation During ARDS (RIAMA): a Proof-of-concept Clinical Study
|
||
| Withdrawn |
NCT02253667 -
Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Lung Disease Patients
|
N/A | |
| Completed |
NCT02232841 -
Electrical Impedance Imaging of Patients on Mechanical Ventilation
|
N/A | |
| Completed |
NCT02889770 -
Dead Space Monitoring With Volumetric Capnography in ARDS Patients
|
N/A | |
| Completed |
NCT01504893 -
Very Low Tidal Volume vs Conventional Ventilatory Strategy for One-lung Ventilation in Thoracic Anesthesia
|
N/A | |
| Withdrawn |
NCT01927237 -
Pulmonary Vascular Effects of Respiratory Rate & Carbon Dioxide
|
N/A | |
| Completed |
NCT02814994 -
Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients
|
N/A | |
| Completed |
NCT01680783 -
Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure
|
N/A |