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NCT00848731 · ClinicalTrials.gov registry record · Phase 1
Phase I Trial of Inhaled Nitric Oxide to Treat Acute Pulmonary Embolism
A Phase 1 study of Pulmonary Embolism, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT00848731 is a Phase 1 study of Pulmonary Embolism that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 25 participants, below the 3,058-participant average among 48 other Pulmonary Embolism trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00848731, a Phase 1 study of Pulmonary Embolism, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study 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. 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. 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). Absolute safety endpoints: Two consecutive SBP measurements more than one min apart with both readings \< 80 mm Hg;SaO 2 \<80% for more than 15 seconds; Patient deterioration as defined by: Clinical decision for need of inotropic or pressor support for any reason, seizure, new altered mental status, focal neurological signs suggestive of cerebral ischemia, evidence of myocardial ischemia, protracted vomiting. 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 Studied
Interventions
- DRUG nitric oxide
Study Locations (1)
North Carolina
- Carolinas Medical Center - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2009-02 |
| Est. Completion | 2011-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00848731
The ClinicalTrials.gov registry entry for NCT00848731 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,058-participant average among 48 other Pulmonary Embolism trials with a reported enrollment target (99% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pulmonary Embolism appearing as the primary indexed condition, and to 1 intervention - of which nitric oxide is the first listed.
NCT00848731 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT00848731 about?
NCT00848731 is a clinical study titled "Phase I Trial of Inhaled Nitric Oxide to Treat Acute Pulmonary Embolism". 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,...
What is the current status of trial NCT00848731?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2009-02. Estimated completion is 2011-05.
What conditions does trial NCT00848731 study?
This clinical trial studies the following conditions: Pulmonary Embolism.
What interventions are being tested in trial NCT00848731?
The interventions under investigation include: nitric oxide (DRUG).
Who is sponsoring clinical trial NCT00848731?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00848731 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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