Status:
COMPLETED
Phase I Trial of Inhaled Nitric Oxide to Treat Acute Pulmonary Embolism
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Detailed Description
We propose to enroll a total of 25 patients with recently diagnosed pulmonary embolism. Inclusion criteria will include moderate to severe shortness of breath as rated by the patient on a standard sco...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00848731
Start Date
February 1 2009
End Date
May 1 2011
Last Update
April 25 2022
Active Locations (1)
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1
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203