NCT00569855

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
785

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2001

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 10, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
7 months until next milestone

Results Posted

Study results publicly available

March 1, 2011

Completed
Last Updated

March 1, 2011

Status Verified

February 1, 2011

Enrollment Period

9.5 years

First QC Date

December 6, 2007

Results QC Date

January 12, 2011

Last Update Submit

February 3, 2011

Conditions

Open-heart SurgeryCardiopulmonary Bypass

Outcome Measures

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

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

    72 hours postoperatively

Study Arms (1)

1

EXPERIMENTAL

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

Drug: Phenoxybenzamine

Interventions

PhenoxybenzamineDRUG

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

Also known as: Dibenzyline
1

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Parental refusal to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72207, United States

Location

MeSH Terms

Interventions

Phenoxybenzamine

Intervention Hierarchy (Ancestors)

EthylaminesAminesOrganic Chemicals

Results Point of Contact

Title
Research Program Manager, Cardiovascular Surgery, Dept. of Pediatrics
Organization
University of Arkansas, Arkansas Children's Hospital, Dept. of Pediatrics
althagekarena@uams.edu
501-364-1100

Study Officials

  • Michiaki Imamura, MD

    Arkansas Childrens Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 6, 2007

First Posted

December 10, 2007

Study Start

February 1, 2001

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

March 1, 2011

Results First Posted

March 1, 2011

Record last verified: 2011-02

Locations

US(1)