Cardiopulmonary Bypass Clinical Trial
Official title:
Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery
Verified date | February 2011 |
Source | University of Arkansas |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 785 |
Est. completion date | August 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 18 Years |
Eligibility |
Inclusion Criteria: - 0-18 years of age - weight of less than or equal to 20 kilograms Exclusion Criteria: - Parental refusal to give informed consent |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Arkansas Children's Hospital | Little Rock | Arkansas |
Lead Sponsor | Collaborator |
---|---|
University of Arkansas | Arkansas Children's Hospital Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | Number of subjects who required Norepinephrine >0.1mcq/kg/min | 72 hours postoperatively | Yes |
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