Phase 2
N=206
Dose-response Study of Sodium Nitroprusside in Children Requiring Controlled Hypotension in the Operating Room
Hypotension
Bottom Line
View on ClinicalTrials.gov: NCT00135668 ↗Enrolled (actual)
206
Serious AEs
41.4%
Results posted
Jan 2024
Primary outcome: Primary: Change in Mean Arterial Pressure (MAP) From the Baseline MAP — 76.3; 76.9; 73.5; 76.3 mm Hg — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nitroprusside (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- The Emmes Company, LLC
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Arterial Pressure (MAP) From the Baseline MAP |
76.3; 76.9; 73.5; 76.3; 75.7; 65.3 | <0.001 sig |
| PRIMARY Overall Summary of Tolerability/Adverse Events (AEs) for ITT Safety Population |
50; 49; 53; 51; 203; 5 | — |
| SECONDARY Change From Baseline MAP Nitroprusside Infusion During the Blinded Infusion; |
76.3; 76.9; 73.5; 76.3; 75.7; 69.6 | — |
| SECONDARY Infusion Rate of Sodium Nitroprusside That Reduces MAP to a Predetermined Clinically Meaningful Target Value +/- 10%; |
0.47; 0.70; 1.21; 1.86; 1.07 | — |
| SECONDARY Number of Participants Who Reach Target MAP; |
48; 49; 52; 51; 200; 2 | — |
Summary
Sodium nitroprusside (SNP) has been approved for control of blood pressure in adults, yet there are no controlled studies in children. The purpose of this study is to determine the efficacy and safety of sodium nitroprusside in children who will be having surgery, and who require blood pressure lowering in order to decrease the amount of blood loss during their surgery.
Eligibility Criteria
Inclusion Criteria
Study subjects must meet all of the following criteria:
- Subject is less than 17 years of age
- Neonates must be full-term gestation and have a body weight of at least 2.5 kg
- Subject requires pharmacologically-induced hypotension for acute blood pressure management for surgery or other invasive procedure, e.g., cerebral artery embolization
- Duration of the subject's controlled hypotension is expected to be ≥ 2 hours
- Subject requires general anesthesia with endotracheal intubation
- Subject requires placement of intra-arterial line during the surgical or medical procedure
- The subject's parent or legal guardian gives permission (informed consent) and subject gives assent when appropriate.
Exclusion Criteria
Subjects will be excluded if any of the following criteria exist:
- 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 procedures
- Subject has participated in other clinical trials for investigational drugs and/or devices within 30 days prior to enrollment
- 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 human chorionic gonadotropin (HCG) test administered at screening.
Data sourced from ClinicalTrials.gov (NCT00135668). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.