Cardiopulmonary Bypass, Open-heart Surgery
Conditions
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.
Interventions
DRUGPhenoxybenzamine
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
Sponsors
Arkansas Children's Hospital Research Institute
University of Arkansas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* 0-18 years of age * weight of less than or equal to 20 kilograms
Exclusion criteria
* Parental refusal to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 72 hours postoperatively | Number of subjects who required Norepinephrine \>0.1mcq/kg/min |
Countries
United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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 | 785 |
| Total | 785 |
Baseline characteristics
| Characteristic | Subjects Who Received Study Drug |
|---|---|
| Age, Categorical <=18 years | 785 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Region of Enrollment United States | 785 participants |
| Sex: Female, Male Female | 390 Participants |
| Sex: Female, Male Male | 395 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 785 |
| serious Total, serious adverse events | 2 / — |
Outcome results
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
Time frame: 72 hours postoperatively
Population: No. of subjects consented = 832; 785 subjects received study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Who Received Study Drug | 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 |