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Parenteral Phenoxybenzamine During Congenital Heart Disease Surgery

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ClinicalTrials.gov Identifier: NCT00770705
Recruitment Status : Withdrawn (poor enrollment)
First Posted : October 10, 2008
Last Update Posted : May 1, 2017
Information provided by (Responsible Party):
David Bichell, Vanderbilt University

Brief Summary:
Phenoxybenzamine, an irreversible alpha-adrenergic blocker, may prove beneficial to infants and children with congenital heart disease undergoing open cardiac repair, due to a theoretic benefits of a uniform and smooth reduction in systemic vascular resistance in the perioperative period. Vasodilation allows for low pressure, high flow systemic perfusion while on cardiopulmonary bypass. Support for the use of phenoxybenzamine in humans has been documented in several studies involving the perioperative management of both adults and children requiring cardiopulmonary bypass, and in management of patients with pheochromocytoma. 1-7 Phenoxybenzamine has been associated with more uniform body cooling and rewarming, and improved tissue perfusion during bypass.8 It is also known to increase cardiac output, stroke volume, and renal blood flow when given intravenously. 9 Specifically in pediatric open heart surgery, the combined use of phenoxybenzamine and dopamine provided a stable hemodynamic condition without a high total peripheral vascular resistance and stimulated postoperative diuresis. 9 Afterload reduction with parenteral phenoxybenzamine in neonates undergoing the Norwood procedure for hypoplastic left heart syndrome is associated with improved systemic oxygen delivery and stabilization of systemic vascular resistance.10 Furthermore, a strategy of reducing afterload with phenoxybenzamine and stabilizing the pulmonary to systemic flow ratio in this select population of patients has also been shown to improve operative survival. 11 We hypothesize that phenoxybenzamine will reduce afterload on the systemic ventricle in our selected patient population, thereby improving ventricular performance and decreasing the risks of pulmonary to systemic flow imbalance associated with current short-acting vasodilator therapy. We will plan to evaluate both physiologic variables as well as surgical outcomes in the selected study population.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Drug: Phenoxybenzamine Other: Standard surgical approach Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Parenteral Phenoxybenzamine During Congenital Heart Disease Surgery
Actual Study Start Date : October 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

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Arm Intervention/treatment
Experimental: 1
Group receiving phenoxybenzamine
Drug: Phenoxybenzamine
The drug will be administered in the operating room. After induction of anesthesia and the pIacement of appropriate cardiovascular monitoring lines, an initial loading dose of 0.25 mg/kg will be administered intravenously immediately prior to cardiopulmonary bypass.For up to 72 hours postoperatively, 0.25 mg/kg/day will be administered Based on published pharmacokinetic data these doses should block 90 -95% of alpha-peripheral receptors with a half life of 24 - 36 hours for regeneration.

Historical control
Other: Standard surgical approach
Historical controls

Primary Outcome Measures :
  1. Our hypothesis is that the use of phenoxybenzamine in this select population will reduce initial postoperative lactate levels by a clinically-relevant level of 25%, relative to historical controls. [ Time Frame: To discharge ]

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Patient selection will be determined by an assessment of the risk of systemic ventricular dysfunction following open cardiac repair in a population of infants undergoing stage I palliation (Norwood procedure) for the diagnosis of either hypoplastic left heart syndrome or similar left-sided obstructive lesions in the setting of single-ventricle physiology. Eligible neonates and infants include those aged 0 days to 6 months. These patients will be evaluated on an individual basis and the decision to give phenoxybenzamine would be determined by the attending surgeon, anesthesiologist, and cardiologist.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00770705

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United States, Tennessee
Vanderbilt Children's Hospital
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
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Principal Investigator: David P Bichell, MD Vanderbilt Children's Hospital
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Responsible Party: David Bichell, Cardiac Surgery Professor and Pediatric Cardiac Surgery Chief, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00770705    
Other Study ID Numbers: IRB#071183
First Posted: October 10, 2008    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents