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Sponsored by: |
Carolinas Healthcare System |
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Information provided by: | Carolinas Healthcare System |
ClinicalTrials.gov Identifier: | NCT00848731 |
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
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.
Condition | Intervention | Phase |
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Pulmonary Embolism |
Drug: nitric oxide |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Single Blind (Subject), Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I Trial of Inhaled Nitric Oxide to Treat Acute Pulmonary Embolism |
Estimated Enrollment: | 25 |
Study Start Date: | February 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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iNO: Experimental
gaseous NO is delivered by facemask
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Drug: nitric oxide
nitric oxide gas is delivered by facemask
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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 scoring system, a systolic blood pressure of >89 mm Hg unless the patient has a known prior history of low blood pressure, and blood oxygen saturation of >80%. Exclusion criteria will include: altered mental status, inability to use a nasal cannula, a large need for supplemental oxygen, pregnancy, pneumothorax, recent use of nitrate-containing medications, recent use of thrombolytic drugs, requirement for inotropic or pressor support, or a level of methemoglobin greater than 10%. After obtaining informed consent, subjects will have blood drawn and vital signs will be obtained. They will subsequently begin to breathe oxygen and NO supplied through a nasal cannula delivered from the iNOvent device.
The patients will undergo serial measurements of their blood pressure, arterial oxygen saturation and will have their serum methemoglobin level monitored via a non-invasive probe. Titration of the amount of NO delivered will be made periodically based on the patient's vital signs. If an absolute safety endpoint is reached, NO will be rapidly weaned. Based on the patient's response to NO as determined by their vital signs, a maintenance dose of NO, not to exceed 25 ppm, will be reached. Subjects will continue to receive this concentration for up to 2 hours prior to weaning. Patients will be asked once more to rate the severity of their shortness of breath and blood will be drawn just prior to weaning. Should the patient reach a safety endpoint, the NO will be weaned at an earlier timepoint. We will determine the percentage of patients able to complete the full protocol without reaching a safety endpoint, the percent change in methemoglobin level, the trend in patient-reported shortness of breath, percent change in SBP and oxygen saturation and the number of patients who withdraw during induction for any reason.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
Concurrent therapies including:
United States, North Carolina | |
Carolinas Medical Center | Recruiting |
Charlotte, North Carolina, United States, 28203 | |
Contact: Jeffrey A Kline, MD 704-355-7092 jkline@carolinas.org | |
Sub-Investigator: Alan E Jones, MD | |
Sub-Investigator: Michael R Marchick, MD | |
Sub-Investigator: John S Garrett, MD | |
Sub-Investigator: William Tsia, MD |
Responsible Party: | Carolinas Medical Center ( Jeffrey A. Kline/Director of Research, Department of Emergency Medicine ) |
Study ID Numbers: | CMC_kline_iNO1.1 |
Study First Received: | February 19, 2009 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00848731 History of Changes |
Health Authority: | United States: Food and Drug Administration |
pulmonary hypertension venous thromboembolism |
Vasodilator Agents Neurotransmitter Agents Antioxidants Pulmonary Embolism Vascular Diseases Anti-Asthmatic Agents Cardiovascular Agents Venous Thromboembolism Thromboembolism Thrombosis |
Nitric Oxide Embolism and Thrombosis Respiratory Tract Diseases Hypertension, Pulmonary Embolism Lung Diseases Peripheral Nervous System Agents Bronchodilator Agents Hypertension |
Respiratory System Agents Vasodilator Agents Neurotransmitter Agents Antioxidants Pulmonary Embolism Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Vascular Diseases Anti-Asthmatic Agents Cardiovascular Agents Protective Agents Pharmacologic Actions |
Nitric Oxide Embolism and Thrombosis Respiratory Tract Diseases Embolism Autonomic Agents Therapeutic Uses Lung Diseases Free Radical Scavengers Endothelium-Dependent Relaxing Factors Cardiovascular Diseases Peripheral Nervous System Agents Bronchodilator Agents |