Trial Outcomes & Findings for Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery (NCT NCT00569855)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

785 participants

Primary outcome timeframe

72 hours postoperatively

Results posted on

2011-03-01

Participant Flow

The patient population eligible for enrollment included those pediatric patients 20 kilograms or less in weight undergoing open-heart surgery requiring extracorporeal circulation (cardiopulmonary bypass) at Arkansas Children's Hospital, regardless of their gender or ethnic background

Participant milestones

Participant milestones
Measure	Subjects Who Received Study Drug Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg
Overall Study STARTED	785
Overall Study COMPLETED	785
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects Who Received Study Drug n=785 Participants Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg
Age, Categorical <=18 years	785 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	390 Participants n=5 Participants
Sex: Female, Male Male	395 Participants n=5 Participants
Region of Enrollment United States	785 participants n=5 Participants

PRIMARY outcome

Timeframe: 72 hours postoperatively

Population: No. of subjects consented = 832; 785 subjects received study drug

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

Outcome measures

Outcome measures
Measure	Subjects Who Received Study Drug n=785 Participants Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg
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	25 participants

Adverse Events

Subjects Who Received Study Drug

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Subjects Who Received Study Drug n=785 participants at risk Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg
Surgical and medical procedures Early Death- defined as death within 72 hours of treatment with study drug	0.25% 2/785 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

Research Program Manager, Cardiovascular Surgery, Dept. of Pediatrics

University of Arkansas, Arkansas Children's Hospital, Dept. of Pediatrics

Phone: 501-364-1100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place