Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NICHD-2003-09-DR |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Nitroprusside is used commonly in the Intensive Care Unit for long periods of time in order to reduce blood pressure. It is not known if the body compensates over time to the blood pressure lowering, and if when the nitroprusside is stopped the blood pressure goes up at a faster rate and is higher than it was at the start of the treatment. This study will answer these questions.
This is a phase 2, multicenter, randomized, double-blind placebo-controlled, parallel group study to determine the persistence of the effect of SNP on blood pressure and to assess the potential for rebound hypertension associated with prolonged infusion in pediatric subjects.
The primary endpoint is the change in MAP during the Blinded Study Drug Administration Phase in the absence of other stimuli.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Blinded nitroprusside infusion |
|
| 2 | Placebo Comparator | Blinded placebo infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nitroprusside | Drug | nitroprusside continuous infusion, dose to be titrated to clinical effect |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is the change in MAP during the Blinded Study Drug Administration Phase in the absence of other stimuli. | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| 1. To compare the proportion of patients randomized to receive either sodium nitroprusside or placebo who experience offset during the 30-minute blinded study drug period. | 8 months | |
| 2. To compare the proportion of patients randomized to receive either sodium nitroprusside or placebo who experience rebound hypertension during blinded study drug period |
Not provided
Inclusion Criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Scott Schulman, MD | Duke University | Principal Investigator |
| Greg Hammer, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States | ||
| Stanford University School of Medicine |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 26, 2012 | |
| Unrelease | Yes | |
| Release | Jan 21, 2014 |
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo infusion | Drug | blinded placebo infusion, to be infused at same rate as open-label nitroprusside infusion |
|
| 8 months |
| 3. To compare the proportion of patients randomized to receive either sodium nitroprusside or placebo who experience a serious adverse event during the 30-minute blinded study drug period | 8 months |
| 4. To compare the distribution of patients randomized to receive either sodium nitroprusside or placebo who experience a treatment-emergent and related adverse event, by maximum severity grade, during the 30-minute blinded study drug period. | 8 months |
| 5. To compare the changes in vital signs (systolic blood pressure, diastolic blood pressure, MAP, and heart rate) between patients randomized to receive either sodium nitroprusside or placebo | 8 months |
| 6. To compare the changes in individual laboratory parameters between patients randomized to receive either sodium nitroprusside or placebo. | 8 months |
| Stanford |
| California |
| 94305 |
| United States |
| Kosair Charities Pediatric Clinical Research Unit | Louisville | Kentucky | 40202 | United States |
| University of Michigan - Mott Children's Hospital | Ann Arbor | Michigan | 48109-0243 | United States |
| University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27500 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| Reset | Mar 26, 2014 |
| Release | May 15, 2014 |
| Reset | Jun 16, 2014 |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 26, 2012 | Yes | |||
| Jan 21, 2014 | Mar 26, 2014 | |||
| May 15, 2014 | Jun 16, 2014 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009599 | Nitroprusside |
| ID | Term |
|---|---|
| D005292 | Ferricyanides |
| D003486 | Cyanides |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D006856 | Hydrogen Cyanide |
| D017672 | Nitrogen Compounds |
Not provided
Not provided