Recruiting
Phase 1

Nebulized Sodium Nitroprusside

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT01619280

Conditions

Acute Lung Injury

Acute Respiratory Distress Syndrome

Sodium Nitroprusside

Hypoxia

Respiratory Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sodium Nitroprusside

Study Details

Brief 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.

Conditions

Acute Lung Injury

Acute Respiratory Distress Syndrome

Sodium Nitroprusside

Hypoxia

Respiratory Failure

Study ID

NCT01619280

Start date

May, 2012

Status verified date

Jun, 2012

Completion date

Jun, 2013

Anticipated

Primary completion date

Jun, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 18
2. Negative β-hCG in women of child bearing age (age ≤ 50)
3. Developed ALI within past 72 hours:

  • PaO2/FiO2 < 300;
  • Bilateral infiltrates on CXR;
  • No clinical evidence of elevated left atrial pressure ie. Heart failure as the cause of hypoxia and bilateral infiltrates; and
  • Recognized risk factor for ALI such as: pneumonia, aspiration pneumonitis, acute pancreatitis, massive blood transfusion, or sepsis
4. FiO2 ≥ 0.5
5. PEEP ≥ 8 cm H2O
6. Invasive arterial blood pressure line
7. Endotracheal intubation or tracheostomy
8. Conventional mechanical ventilation
9. Mean Arterial Pressure (MAP) ≥ 65 mmHg with or without use of vasopressors (stable for at least more than 1 hour)
10. Arterial pH ≥ 7.15

Exclusion Criteria:

1. Chest tube with active leak (eg. bronchopulmonary fistula),
2. Prone ventilation, inhaled nitric oxide, inhaled prostacyclin, high frequency oscillatory ventilation,
3. Lack of consent,
4. Untreated coarctation of aorta, symptomatic or severe/critical aortic stenosis as documented by echocardiogram or clinical history,
5. Evidence of increased intracranial pressure (eg. dilated pupils, known intracranial trauma or mass on head CT),
6. SpO2 <90%,
7. Contraindication to SNP i.e. hypersensitivity, congenital optic atrophy, tobacco amblyopia,
8. Active treatment with IV or transdermal nitroglycerin,
9. G6PD deficiency
10. CrCl < 30 ml/min or receiving renal replacement therapy, or
11. Total bilirubin > 68 µmol/L and AST or ALT level 2 times the upper limit of normal.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nebulized sodium nitroprusside

Interventions

Sodium Nitroprusside

Each subject will receive one of five possible dosages of nebulized sodium nitroprusside. The dosage will be determined by the 3 + 3 dose escalation design. Only a maximum of six patients will be given a particular dosage. Arterial blood gases will be drawn at 0 min, 15 min, 30 min and 45 min during nebulized sodium nitroprusside administration. Vitals signs will be recorded every five minutes. No changes to ventilator settings or vasopressor dosage or fluid administration will be allowed.

Primary outcome measure

  • The maximum tolerable dosage of nebulized sodium nitroprusside. This will be determined by the 3 + 3 dose finding design. [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

Locations

Mount Sinai Hospital, University of Toronto

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Principal Investigator:

Terence Ip, MD

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Jun 14, 2012

Last verified

Jun, 2012

Keywords

  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome
  • Sodium Nitroprusside
  • adult
  • Safety
  • Dose Finding
  • Phase 1
  • 3 + 3 design
  • Nebulizers and Vaporizers
  • High-Frequency Ventilation
  • nitric oxide
  • lung injury
  • Pulmonary Gas Exchange
  • Pulmonary Alveoli

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2012-06-14.