HypertensionPhase 2NCT00621816
Sodium Nitroprusside for Blood Pressure Reduction in the ICU (SNP2)
A Phase 2 study testing nitroprusside in people with Hypertension, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 8 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Hypertension
- What is being tested?
- nitroprusside
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 8 sitesUnited States
- Study dates
- Jan 2009to Jan 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject is less than 17 years of age.
- An in-dwelling arterial line is clinically indicated.
- Subject's parent or legal guardian is willing and able to give informed parental permission signing and dating an IRB-approved informed parental permission containing all of the elements of informed consent, and subject provides assent, signing an IRB-approved and -required informed assent, if applicable.
- Subject is anticipated to require a minimum of 20 mm Hg (15 mm Hg for subjects < 2 years old) reduction in MAP for at least 12 hours using SNP [i.e., MAPB1 - MAPB2 ≥ 20 mm Hg (15 mm Hg for subjects < 2 years old)]
Who cannot join
- Subject weighs < 3.0 kg.
- Subject has a known allergy to SNP.
- Subject has a known mitochondrial cytopathy with a disorder of oxidative phosphorylation or of respiratory chain enzymes.
- Subject has a contraindication to vasodilator therapy for control of blood pressure during surgery or in the intensive care unit.
- Subject has raised intracranial pressure.
- Subject is anticipated to need anti-hypertensive drugs other than Sodium Nitroprusside either IV (e.g. dexmedetomidine, esmolol, etc.) or epidural (e.g.local anesthetics, clonidine, etc.) within three terminal half-lives (3X T½ β) of the blinded study drug period. However, patients receiving stable doses of an anti-hypertensive drug(s) prior to the initiation of study drug may be enrolled.
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- Subject has any serious medical condition which, in the opinion of the investigator, is likely to interfere with study procedures.
- Subject is moribund (death likely to occur within 48 hours).
- Subject has a positive result for the urine or serum HCG test administered at screening.
- Subject has participated in other clinical trials for investigational drugs within 30 days prior to enrollment
- Subject has received or will have received Sodium Thiosulfate within 6 hours prior to the start of the open-label period.
- Subject is either on, or anticipated to be on, ECMO.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Michigan - Mott Children's Hospital
Ann Arbor, Michigan, 48109-0243
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27500
Duke University Medical Center
Durham, North Carolina, 27705
Duke University Medical Center
Durham, North Carolina, 27710
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, 40202
West Virginia University
Morgantown, West Virginia, 26506
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Determine the Pharmacodynamics of Sodium Nitroprusside During Prolonged Infusion in Pediatric Subjects
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.
Read the detailed description
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.
- Conditions
- Hypertension
- Being tested
- nitroprusside, placebo infusion
- Keywords
- nitroprusside, intensive care unit, hypertension, blood pressure reduction
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nitroprussideDrug
Also called Nipride
nitroprusside continuous infusion, dose to be titrated to clinical effect
placebo infusionDrug
blinded placebo infusion, to be infused at same rate as open-label nitroprusside infusion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Blinded nitroprusside infusion Receives: Drug: nitroprusside |
| 2 | Placebo comparator | Blinded placebo infusion Receives: Drug: placebo infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the change in MAP during the Blinded Study Drug Administration Phase in the absence of other stimuli.
Measured: 8 months
Secondary outcomes (6)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 8 months
6. To compare the changes in individual laboratory parameters between patients randomized to receive either sodium nitroprusside or placebo.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startJan 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Scott Schulman, MD, Principal investigator, Duke UniversityGreg Hammer, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621816
- Sponsor's protocol ID
- N01-HD-4-3386
- Other IDs
- NICHD-2003-09-DR
- Status last verified
- Apr 2011
- First submitted
- 20 Feb 2008
- Last updated
- 6 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Determine the Pharmacodynamics of Sodium Nitroprusside During Prolonged Infusion in Pediatric Subjects
- ClinicalTrials.gov ID
- NCT00621816
- Acronym / sponsor ID
- N01-HD-4-3386
- Conditions
- Hypertension
- Keywords
- nitroprusside, intensive care unit, hypertension, blood pressure reduction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: nitroprussideBlinded nitroprusside infusion |
| 2 | Placebo comparator | Drug: placebo infusionBlinded placebo infusion |
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subject is less than 17 years of age.
- An in-dwelling arterial line is clinically indicated.
- Subject's parent or legal guardian is willing and able to give informed parental permission signing and dating an IRB-approved informed parental permission containing all of the elements of informed consent, and subject provides assent, signing an IRB-approved and -required informed assent, if applicable.
- Subject is anticipated to require a minimum of 20 mm Hg (15 mm Hg for subjects < 2 years old) reduction in MAP for at least 12 hours using SNP [i.e., MAPB1 - MAPB2 ≥ 20 mm Hg (15 mm Hg for subjects < 2 years old)]
Key exclusion criteria (12 listed)
- Subject weighs < 3.0 kg.
- Subject has a known allergy to SNP.
- Subject has a known mitochondrial cytopathy with a disorder of oxidative phosphorylation or of respiratory chain enzymes.
- Subject has a contraindication to vasodilator therapy for control of blood pressure during surgery or in the intensive care unit.
- Subject has raised intracranial pressure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nitroprussideAlso: Nipridenitroprusside continuous infusion, dose to be titrated to clinical effect | Drug | 1 |
| placebo infusionblinded placebo infusion, to be infused at same rate as open-label nitroprusside infusion | Drug | 2 |
Primary outcome
The primary endpoint is the change in MAP during the Blinded Study Drug Administration Phase in the absence of other stimuli.
Time frame: 8 months
6 secondary outcomes
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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 8 months
6. To compare the changes in individual laboratory parameters between patients randomized to receive either sodium nitroprusside or placebo.
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Schulman, MD principal investigator
Duke University
Greg Hammer, MD principal investigator
Stanford University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nitroprusside in people with Hypertension, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the change in MAP during the Blinded Study Drug Administration Phase in the absence of other stimuli. (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2011.