Trial Outcomes & Findings for Use of Phenoxybenzamine [PBZ] IV to Assist High Flow Low Pressure Perfusion [HFLPP] on Cardio-pulmonary Bypass (NCT NCT00620945)

Results Overview

Percentage of patients who achieved high flow, low pressure on cardiopulmonary bypass

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

87 participants

Primary outcome timeframe

From time of cardiopulmonary bypass initiation until the time that high flow, low pressure on cardiopulmonary bypass was achieved, assessed up to 1 hour

Results posted on

2017-12-19

Participant Flow

Dates of Recruitment: June 2006 to September 2008

Participant milestones

Participant milestones
Measure	Phenoxybenzamine Treatment Treatment Group- patients treated with phenoxybenzamine
Overall Study STARTED	87
Overall Study COMPLETED	87
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phenoxybenzamine n=87 Participants Treatment Group Phenoxybenzamine: Use of Phenoxybenzamine: Loading dose given at the time of going on CPB: * For patients with obstructing lesions on systemic side: * 0.25 mg/kg dose in the bypass circuit * None intravenous * For patients without obstructing left sided lesions: * 0.5 mg/kg in the bypass circuit * 0.5 mg/kg I.V. at cannulation Maintenance dose given in the post-operative period: * 0.3 mg/kg I.V. every 8 hours till oral intake is started or for first 48 hours * 0.3 mg/kg P.O. every 8 hours for next 24 hours * 0.15 mg/kg P.O. every 8 hours for next 24 hours and then stop * Hold PBZ if the patient is on norepinephrine infusion or the mean arterial pressure is lower than that allowed for the age group
Age, Categorical <=18 years	87 Participants n=87 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=87 Participants
Age, Categorical >=65 years	0 Participants n=87 Participants
Sex: Female, Male Female	42 Participants n=87 Participants
Sex: Female, Male Male	45 Participants n=87 Participants
Region of Enrollment United States	87 Participants n=87 Participants

PRIMARY outcome

Timeframe: From time of cardiopulmonary bypass initiation until the time that high flow, low pressure on cardiopulmonary bypass was achieved, assessed up to 1 hour

Percentage of patients who achieved high flow, low pressure on cardiopulmonary bypass

Outcome measures

Outcome measures
Measure	Phenoxybenzamine Treatment n=87 Participants Treatment Group- patients treated with phenoxybenzamine
Number of Participants Achieving High Flow Low Pressure on Cardiopulmonary Bypass	87 Participants

SECONDARY outcome

Timeframe: 30 days

Percentage of patients who died within 30 days of the procedure

Outcome measures

Outcome measures
Measure	Phenoxybenzamine Treatment n=87 Participants Treatment Group- patients treated with phenoxybenzamine
Mortality	5 Participants

Adverse Events

Phenoxybenzamine

Serious events: 5 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Phenoxybenzamine n=87 participants at risk Treatment Group Phenoxybenzamine: Use of Phenoxybenzamine: Loading dose given at the time of going on CPB: * For patients with obstructing lesions on systemic side: * 0.25 mg/kg dose in the bypass circuit * None intravenous * For patients without obstructing left sided lesions: * 0.5 mg/kg in the bypass circuit * 0.5 mg/kg I.V. at cannulation Maintenance dose given in the post-operative period: * 0.3 mg/kg I.V. every 8 hours till oral intake is started or for first 48 hours * 0.3 mg/kg P.O. every 8 hours for next 24 hours * 0.15 mg/kg P.O. every 8 hours for next 24 hours and then stop * Hold PBZ if the patient is on norepinephrine infusion or the mean arterial pressure is lower than that allowed for the age group
Cardiac disorders Myocardial dysfunction	3.4% 3/87 • Number of events 3
Vascular disorders Pulmonary hypertension	2.3% 2/87 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

Muhammad A. Mumtaz, MD

Cleveland Clinic

Phone: 216 444 9125

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place