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A Randomized Controlled Trial of the use of Long-Term Propranolol in Severely Burned Pediatric Patients
David N Herndon1, Sachin D Hegde*1, Noe A Rodriguez*1, Jaipreet S Suri*1, Eva Diaz*1, Henry V Baker*2, Cecilia M Lopez*2, Ronald Mlcak*1, Felicia N Williams*1, Robert Barrow*1, Ronald G Tompkins3, Lyle L. Moldawer*2, Walter Meyer*1, Oscar E Suman*1, Marc G Jeschke*1, Celeste C Finnerty*1
1University of Texas Medical Branch, Galveston, TX;2University of Florida, Gainesville, FL;3Massachusetts General Hospital, Boston, MA

OBJECTIVE(S): Severe burn injury results in a hypermetabolic response that persists up to 2 years post injury. The purpose of this study was to determine the effects of long-term administration of propranolol on the hypermetabolic state, cardiac function, body composition, inflammatory responses, and molecular signaling in a large prospective randomized single-center controlled trial.
METHODS: 196 pediatric patients with burns >30% of total body surface area were prospectively enrolled. Patients were randomized to receive either placebo (n=86) or 4mg/kg/day propranolol (n=108) for 12 months post burn. Cardiac function, body composition, hormones and inflammatory mediators were measured at discharge, and 6, 9, 12, 18 and 24 months post burn. Affymetrix U133 plus 2.0 microarrays were performed on muscle biopsies to identify tissue-specific molecular responses. Tukey t test or ANOVA followed by Bonferroni correction were applied as appropriate, significance was accepted at P < 0.05.
RESULTS: Long term propranolol treatment significantly reduced cardiac work, liver weight, and inflammation as represented by IL-6 and MCP-1during the first year, p<0.05. In muscle biopsies, significant alterations in genes controlling cAMP signaling, glucose metabolism, muscle protein processing, and angiogenesis of endothelial cells were seen during the first year, p<0.001.
CONCLUSIONS: Propranolol treatment for 12 months following injury ameliorates the hyperdynamic and inflammatory response in severely burned pediatric patients. These results indicate that tailoring the propranolol dosage to molecular events may result in greater improvements in long-term outcomes.

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