Phase I Trial of Inhaled Nitric Oxide to Treat Acute Pulmonary Embolism

NCT00848731 | Completed Phase 1

• 1 other identifier: CMC_kline_iNO1.1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the hypothesis that patients with acute PE and dyspnea can safely inhale NO. The secondary hypothesis is that patients who are blinded to the inhaled NO concentration will sustain subjective improvement in their perception of dyspnea based upon their reported Borg dyspnea score, during inhalation of NO. Specific aims

1. 1.Test if patients with acute PE and shortness of breath of severity ≥ 5 on a 0-10 scale called the Borg score can have inhaled nitric oxide administered via nasal cannula or face mask in a titration protocol that increases concentration by 5 ppm in 5 min steps to a maximum of 25 ppm.
2. 2.We will measure the number of patients who meet an absolute safety endpoint during titration. An absolute safety endpoint requires execution of a rapid weaning protocol (2 ppm decrease per minute to 0 ppm).
3. 3.Test if the patient-reported Borg score decreases with administration of NO. Patients will not be told any details about the timing of the titration and will not be made aware of their iNO concentration when the Borg score is assessed.

Conditions

Pulmonary Embolism

Keywords

pulmonary hypertension; venous thromboembolism

Outcome Measures

Primary Outcomes (1)

• Borg score

  3 hours

Secondary Outcomes (1)

• vital signs

  3 hours

Study Arms (1)

iNO

EXPERIMENTAL

gaseous NO is delivered by facemask

Drug: nitric oxide

Interventions

nitric oxide DRUG

nitric oxide gas is delivered by facemask

iNO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of acute PE requires symptoms of PE present \<14 days with CT angiography interpreted as positive for acute PE. Initial evaluation for PE must be predicated upon the investigation of new or unexplained cardiopulmonary or chest-related clinical features consistent with PE, including shortness of breath, chest pain, respiratory distress, dizziness, unexplained tachypnea, tachycardia, syncope, cough or hemoptysis. All patients must have CT chest angiography with \<2 mm collimation,(36) with or without indirect venography. Pulmonary arterial opacification will be achieved with power injection of non-ionic, low osmolar contrast in an antecubital vein with a timing run; the pitch, voltage, gantry speed and other technical details appropriate for each scanner.(37;38) Images will be interpreted as positive for intrapulmonary arterial filling defect consistent with acute PE using our published definitions(37;38) by a board-certified radiologist with specialty training in body CT or emergency medicine imaging in all cases.
• SBP (SBP)\> 89 mm Hg at the time of enrollment. We will allow enrollment for a patient with an SBP \< 90 mm Hg prior to enrollment, or a patient with a SBP\>80 mm Hg, if the patient has a documented or patient-identified history of low blood pressure and has no symptoms of shock, as described by Jones et al.(39)
• SaO2% \>80% at time of enrollment.
• Patients must have a Borg score greater than 4/10.

You may not qualify if:

• Altered mental status such that they are unable to provide consent.
• Inability to use a nasal cannula or face mask (e.g., anatomic defect)
• Supplemental oxygen requirement greater than can be administered via nasal cannula or face mask in order to maintain SaO2 \>80%.
• Pregnancy
• Pneumothorax with decompression
• A serum mtHb greater than 10%
• Concurrent therapies including:
• Viagra® (sildenafil) use within the past 24 hours
• Levitra® (vardenafil) use within the past 24 hours
• Cialis® (tadalafil) use within the past 72 hours
• Use nitroprusside or nitroglycerine with in the past 4 hours
• Concomitant use of pressor or inotropic agents
• Use of fibrinolytic agent with in the past 14 days
• Use of nitrates within the past 24 hours

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

MeSH Terms

Conditions

Pulmonary Embolism; Hypertension, Pulmonary; Venous Thromboembolism

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Hypertension; Thromboembolism

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals

Study Officials

• Jeff A Kline, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2009
• First Posted: February 20, 2009
• Study Start: February 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: April 25, 2022

Record last verified: 2011-06

Locations

US (1)