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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00569855
Other study ID # 06611
Secondary ID
Status Completed
Phase Phase 2
First received December 6, 2007
Last updated February 3, 2011
Start date February 2001
Est. completion date August 2010

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Phenoxybenzamine
0.125 to 1 mg/kg given i.v. over 15 to 45 minutes in preparation for cardiopulmonary bypass; may be continued at 0.125 mg/kg/day in ICU

Locations

Country Name City State
United States Arkansas Children's Hospital Little Rock Arkansas

Sponsors (2)

Lead Sponsor Collaborator
University of Arkansas Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

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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