Skip to main content
OpenTrials
Completed

NCT Number: NCT00569855

Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Open-heart Surgery Cardiopulmonary Bypass

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arkansas Children's Hospital

Little Rock, Arkansas, 72207, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 0-18 years of age
  • weight of less than or equal to 20 kilograms

Exclusion criteria

  • Parental refusal to give informed consent

Treatment and study plan

Phenoxybenzamine

Drug

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

Other names: Dibenzyline

Primary outcomes

  1. 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

    Time frame: 72 hours postoperatively

    Number of subjects who required Norepinephrine >0.1mcq/kg/min

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • Arkansas Children's Hospital Research Institute

Registry information

Important dates

Study start
2001
Primary completion
2010
Study completion
2010
First posted
Dec 10, 2007
Registry last updated
Mar 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.