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| Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00103025 |
Purpose
This study will determine the dose of sodium nitrite that can safely be used to prevent constriction, or tightening, of the arteries. Narrowed arteries in the brain can cause stroke. Animal studies show that nitrite injections improve blood flow and that injections over long periods of time prevent damage to the arteries in the brain; however, there is no information on the effects of prolonged nitrite infusion in humans. This study will establish the safe dose and side effects of nitrite infusion in humans.
Healthy normal volunteers between 21 and 60 years of age may be eligible for this study. Candidates are screened for high or low blood pressure, aspirin use, pregnancy, and blood levels of nitrite and methemoglobin (a substance that temporarily and slightly lowers the oxygen carried in the red blood cells). Pregnant women are excluded from the study.
Participants are admitted to the Clinical Center for 16 1/4 days, the first 2 days in the hospital's intensive care unit (ICU). Upon admission they provide a medical history, have physical and cardiovascular examinations, and blood tests. For the infusion procedure, a catheter (thin plastic tube) is inserted into an artery in the wrist or the crease of the elbow to measure blood pressure, and catheters are placed in a vein in each arm for administering the nitrite and withdrawing blood samples.
In the morning of day 1, after initial blood pressure and heart rate measurements are taken and a blood sample is drawn, a saline (salt water) infusion is started. Blood pressure and heart rate are monitored every 30 minutes for 6 hours, then every hour for 6 hours, then every 2 hours for 12 hours. Blood samples are collected every 4 hours for 24 hours. On day 2, the sodium nitrite infusion begins. Blood pressure and methemoglobin are monitored every 10 minutes for the first 2 hours. If blood pressure remains stable, the frequency of measurements is decreased to every 30 minutes for 4 hours, then every 1 hour for the next 6 hours, and then every 4 hours for 12 hours. If the pressure continues to remain stable, monitoring continues every 8 hours for the rest of the study. Blood is drawn periodically from the catheter to determine the amount of nitrite and methemoglobin in the body, with decreasing frequency from several times during the first hour of the infusion to every 24 hours. After the first 24 to 48 hours of the nitrite infusion, participants are transferred from the ICU to a general nursing unit fo...
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Sodium Nitrite Drug: Sodium Nitrite Injection |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | Evaluation of the Mechanism of NO Formation and Pharmacokinetics of Long-Term Intravenous Nitrite Infusion in Healthy Volunteers |
| Estimated Enrollment: | 16 |
| Study Start Date: | February 2005 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 21 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Subjects must be 21-60 years of age.
Subjects must be in good health.
Subjects must provide informed, written consent for participation in this study.
Female subjects of childbearing age must have a negative pregnancy test and agree to participate in assessment of menstrual cycle duration before, during, and after infusion.
Subjects must be willing to temporarily stop any medications (except oral contraception), vitamin supplements, herbal medicines.
Subjects will have hemoglobin levels above 11.1 g/dL.
EXCLUSION CRITERIA:
Subjects with a history or evidence of present or past hypertension (blood pressure greater than 140/90 mmHg), hypercholesterolemia (LDL cholesterol greater than 130 mg/dL), or diabetes mellitus (fasting blood glucose greater than 126 mg/dL).
Subjects who have a history of smoking within two years.
Subjects who have a history of cardiovascular disease, peripheral vascular disease, coagulopathy, or any other disease predisposing to vasculitis or Raynaud's phenomenon.
Subjects with red blood cell G6PD deficiency (levels below the lower limits of normal).
Subjects with a history of reaction to a medication or other substance characterized by dyspnea and cyanosis.
Subjects with a baseline methemoglobin level greater than 1%.
Pregnant women, since nitrite may cross the placenta; nitrite effect on fetus is unknown and mother's methemoglobinemia may be dangerous to the fetus.
Breast-feeding females, since nitrite crosses into breast milk and could cause methemoglobinemia in the infant.
Subjects with a blood pressure of less than 100/70 mmHg on the study day.
Subjects treated with nitrates (e.g. nitroglycerin).
Contacts and Locations More Information
| Study ID Numbers: | 050075, 05-N-0075 |
| Study First Received: | February 5, 2005 |
| Last Updated: | December 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00103025 History of Changes |
| Health Authority: | United States: Federal Government |
|
Vasodilation Hypotension Hypertension EDRF |
Methemoglobinemia Healthy Volunteer HV |
|
Hypotension Healthy Hypertension |
