Phase 2
Completed N=785
Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery
Source: ClinicalTrials.gov NCT00569855 ↗Enrolled (actual)
785
Serious AEs
—
Results posted
Mar 2011
Primary outcomePrimary: Number of Participants Who Had Significant Hypotension as Defined in the Protocol as Need for Norepinephrine Dose >0.1mcq/kg/Min in the First 72 Hours Postoperatively — 25 participants
Summary
Cardiopulmonary bypass is done with a machine that does the work of the heart and lungs during open-heart surgery. This study is to determine if intravenous (i.v.) phenoxybenzamine is safe. This drug lowers the blood pressure, making it easier for the cardiopulmonary bypass machine to deliver blood and oxygen to all of the organs and tissues.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Had Significant Hypotension as Defined in the Protocol as Need for Norepinephrine Dose >0.1mcq/kg/Min in the First 72 Hours Postoperatively |
25 | — |
Eligibility Criteria
Inclusion Criteria
- 0-18 years of age
- weight of less than or equal to 20 kilograms
Exclusion Criteria
- Parental refusal to give informed consent
Data sourced from ClinicalTrials.gov (NCT00569855). 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. Informational only — not medical advice.