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Vasodilator

Nebulized sodium nitroprusside for Acute Lung Injury

Phase 1
Waitlist Available
Led By Sangeeta Mehta, MD FRCPC
Research Sponsored by Mount Sinai Hospital, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

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.

Eligible Conditions
  • Acute Lung Injury
  • Hypoxia
  • Acute Respiratory Distress Syndrome
  • Sodium Nitroprusside
  • Respiratory Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The maximum tolerable dosage of nebulized sodium nitroprusside. This will be determined by the 3 + 3 dose finding design.
Secondary outcome measures
The change in heart rate (HR), mean blood pressure (MAP) during iSNP administration.
The change in measures of oxygenation (PaO2,SaO2,oxygenation index) during iSNP administration.
The presence or absence of lactate, and/or methemoglobin.

Side effects data

From 2009 Phase 1 trial • 62 Patients • NCT00945256
6%
Back Pain
6%
Redness at biopsy site
6%
Cellulitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Elderly Sodium Nitroprusside
Elderly Sodium Nitroprusside and Amino Acid Drink
Young Aerobic Exercise
Elderly Aerobic Exercise
Young Sodium Nitroprusside

Trial Design

1Treatment groups
Experimental Treatment
Group I: Nebulized sodium nitroprussideExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nitroprusside
FDA approved

Find a Location

Who is running the clinical trial?

Mount Sinai Hospital, CanadaLead Sponsor
196 Previous Clinical Trials
67,578 Total Patients Enrolled
Sangeeta Mehta, MD FRCPCPrincipal InvestigatorDepartment of Critical Care Medicine, University of Toronto
Terence Ip, MDPrincipal InvestigatorDepartment of Critical Care Medicine, University of Toronto

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety Study of Nebulized Sodium Nitroprusside in Adult Acute Lung Injury
2012. "Safety Study of Nebulized Sodium Nitroprusside in Adult Acute Lung Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01619280.
All > Lung
~2 spots leftby May 2025
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