Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery

NCT ID: NCT00569855

Last Updated: 2011-03-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

785 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2010-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Open-heart Surgery Cardiopulmonary Bypass

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Receive phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery

Group Type EXPERIMENTAL

Phenoxybenzamine

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Dibenzyline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Parental refusal to give informed consent
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role collaborator

University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Arkansas for Medical Sciences

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michiaki Imamura, MD

Role: PRINCIPAL_INVESTIGATOR

Arkansas Childrens Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

06611

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Myocardial Protection With Adenosine Preconditioning
NCT00881686 COMPLETED PHASE1/PHASE2
Feasibility of Transepicardial Atrial Injection
NCT05634213 WITHDRAWN EARLY_PHASE1