Use of Phenoxybenzamine [PBZ] IV to Assist High Flow Low Pressure Perfusion [HFLPP] on Cardio-pulmonary Bypass

• ClinicalTrials.gov Identifier: NCT00620945
• Recruitment Status: Terminated
• First Posted: February 22, 2008
• Results First Posted: November 20, 2017
• Last Update Posted: December 19, 2017
• Sponsor: The Cleveland Clinic
• Information provided by (Responsible Party): The Cleveland Clinic

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Congenital Heart Surgery; Cardiopulmonary Bypass
• Intervention: Drug: Phenoxybenzamine
• Enrollment: 87

Participant Flow

Recruitment Details	Dates of Recruitment: June 2006 to September 2008
Pre-assignment Details

Arm/Group Title	Phenoxybenzamine Treatment
Arm/Group Description	Treatment Group- patients treated with phenoxybenzamine
Period Title: Overall Study
Started	87 [1]
Completed	87
Not Completed	0
[1] Total number in the study

Baseline Characteristics

Arm/Group Title		Phenoxybenzamine
Arm/Group Description		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
Overall Number of Baseline Participants		87
Baseline Analysis Population Description		Patients undergoing open heart surgery and who are less than 18 years of age.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	87 participants
	<=18 years	87 100.0%
	Between 18 and 65 years	0 0.0%
	>=65 years	0 0.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	87 participants
	Female	42 48.3%
	Male	45 51.7%
Race and Ethnicity Not Collected [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	87 participants
		87 100.0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Achieving High Flow Low Pressure on Cardiopulmonary Bypass
Description	Percentage of patients who achieved high flow, low pressure on cardiopulmonary bypass
Time Frame	From time of cardiopulmonary bypass initiation until the time that high flow, low pressure on cardiopulmonary bypass was achieved, assessed up to 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenoxybenzamine Treatment
Arm/Group Description:	Treatment Group- patients treated with phenoxybenzamine
Overall Number of Participants Analyzed	87
Measure Type: Count of Participants; Unit of Measure: Participants
	87 100.0%

2. Secondary Outcome

Title	Mortality
Description	Percentage of patients who died within 30 days of the procedure
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenoxybenzamine Treatment
Arm/Group Description:	Treatment Group- patients treated with phenoxybenzamine
Overall Number of Participants Analyzed	87
Measure Type: Count of Participants; Unit of Measure: Participants
	5 5.7%

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Phenoxybenzamine
Arm/Group Description	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
All-Cause Mortality
	Phenoxybenzamine
	Affected / at Risk (%)
Total	5/87 (5.75%)
Serious Adverse Events
	Phenoxybenzamine
	Affected / at Risk (%)	# Events
Total	5/87 (5.75%)
Cardiac disorders
Myocardial dysfunction * [1]	3/87 (3.45%)	3
Vascular disorders
Pulmonary hypertension *	2/87 (2.30%)	2
* Indicates events were collected by non-systematic assessment; [1] Cause of death was myocardial dysfunction, pulmonary hypertension, or myocardial infarction
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Phenoxybenzamine
	Affected / at Risk (%)	# Events
Total	0/87 (0.00%)

Limitations and Caveats

Due to a change in leadership the protocol of cardiopulmonary bypass was changed on 9/22/2008. The high flow low pressure perfusion is no longer used. As a result phenoxybenzamine was no longer able to be studied and the study was closed early.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Muhammad A. Mumtaz, MD
• Organization: Cleveland Clinic
• Phone: 216 444 9125
• EMail: mumtazm@ccf.org

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT00620945
• Other Study ID Numbers: CCF IRB # 06-494
• First Submitted: February 11, 2008
• First Posted: February 22, 2008
• Results First Submitted: October 20, 2017
• Results First Posted: November 20, 2017
• Last Update Posted: December 19, 2017