Faculty Collaboration Database

The safety, efficacy, and pharmacokinetics of esmolol for blood pressure control immediately after repair of coarctation of the aorta in infants and children: a multicenter, double-blind, randomized trial. J Thorac Cardiovasc Surg 2008 Aug;136(2):321-8

Date

08/12/2008

Pubmed ID

18692637

DOI

10.1016/j.jtcvs.2007.09.086

Scopus ID

2-s2.0-48649095538 (requires institutional sign-in at Scopus site)   66 Citations

Abstract

OBJECTIVES: Blood pressure control is important after repair of coarctation of the aorta. We report the first prospective multi-institutional trial addressing the safety and efficacy of esmolol after repair of coarctation of the aorta in infants and children.

METHODS: The primary objective of this phase IIIb, multicenter, double-blind, randomized, dose-ranging trial was the efficacy of esmolol to control hypertension. Candidates included subjects younger than 6 years and weighing 2.5 kg or more who underwent surgical intervention for coarctation of the aorta and required therapy for systemic hypertension. One hundred sixteen subjects received esmolol: 36 received a low dose (125 microg/kg), 43 received a medium dose (250 microg/kg), and 37 received a high dose (500 microg/kg). The primary outcomes were the change in systolic blood pressure and the need for additional antihypertensive rescue medication 5 minutes after the initiation of esmolol.

RESULTS: All dose groups showed a significant decrease from baseline in systolic blood pressure (-9.6 +/- 16.3 mm Hg, P < .001). There were no differences in systolic blood pressure response at 5 minutes between dose groups (high, medium, or low) or age groups. The need for rescue medication at 5 minutes was not different between dose groups. All dose groups showed similar incidences of adverse events. There were no serious adverse events.

DISCUSSION: Esmolol can be administered safely to patients younger than 6 years after repair of coarctation of the aorta. In the dose range of 125 to 500 microg/kg, esmolol significantly decreased systolic blood pressure.

Author List

Tabbutt S, Nicolson SC, Adamson PC, Zhang X, Hoffman ML, Wells W, Backer CL, McGowan FX, Tweddell JS, Bokesch P, Schreiner M

MESH terms used to index this publication - Major topics in bold

Adrenergic beta-Antagonists
Antihypertensive Agents
Aortic Coarctation
Blood Pressure
Dose-Response Relationship, Drug
Double-Blind Method
Female
Humans
Hypertension
Infant
Infant, Newborn
Male
Postoperative Complications
Propanolamines