Sodium Nitroprusside for Blood Pressure Reduction in the ICU (SNP2)

NCT00621816 | Completed Phase 2 DMC

• 2 other identifiers: N01-HD-4-3386NICHD-2003-09-DR
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 8

Brief 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 start of the treatment. This study will answer these questions.

Conditions

Hypertension

Keywords

nitroprusside; intensive care unit; hypertension; blood pressure reduction

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the change in MAP during the Blinded Study Drug Administration Phase in the absence of other stimuli.

  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.

  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

  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

Study Arms (2)

1

ACTIVE COMPARATOR

Blinded nitroprusside infusion

Drug: nitroprusside

2

PLACEBO COMPARATOR

Blinded placebo infusion

Drug: placebo infusion

Interventions

nitroprusside DRUG

nitroprusside continuous infusion, dose to be titrated to clinical effect

Also known as: Nipride

1

placebo infusion DRUG

blinded placebo infusion, to be infused at same rate as open-label nitroprusside infusion

2

Eligibility Criteria

• Age: 1 Day - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 \[i.e., MAPB1 - MAPB2 ≥ 20 mm Hg (15 mm Hg for subjects \< 2 years old)\]

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (8)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Kosair Charities Pediatric Clinical Research Unit

Louisville, Kentucky, 40202, United States

Location

University of Michigan - Mott Children's Hospital

Ann Arbor, Michigan, 48109-0243, United States

Location

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27500, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Nitroprusside

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ferricyanides; Cyanides; Anions; Ions; Electrolytes; Inorganic Chemicals; Ferric Compounds; Iron Compounds; Hydrogen Cyanide; Nitrogen Compounds

Study Officials

• Scott Schulman, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Greg Hammer, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2008
• First Posted: February 22, 2008
• Study Start: January 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: December 6, 2011

Record last verified: 2011-04

Locations

US (8)