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J Thorac Cardiovasc Surg 2005;130:810-816
© 2005 The American Association for Thoracic Surgery

Surgery for Congenital Heart Disease

A randomized, double-blind, placebo-controlled pilot trial of triiodothyronine in neonatal heart surgery

Andrew S. Mackie, MD, SM ^{a , e , _*} , Karen L. Booth, MD ^{a , e} , Jane W. Newburger, MD, MPH ^{a , e} , Kimberlee Gauvreau, ScD ^{a , e} , Stephen A. Huang, MD ^{d , e} , Peter C. Laussen, MBBS ^{a , b , e , f} , James A. DiNardo, MD ^{b , f} , Pedro J. del Nido, MD, PhD ^{c , g} , John E. Mayer, Jr, MD ^{c , g} , Richard A. Jonas, MD ^{c , g , _*} , Ellen McGrath, RN ^{a , e} , Jodi Elder, RN ^{a , e} , Stephen J. Roth, MD, MPH ^{a , e ,}

^a Department of Cardiology, Children's Hospital Boston
^b Department of Anesthesia, Children's Hospital Boston
^c Department of Cardiac Surgery, Children's Hospital Boston
^d Division of Endocrinology, Children's Hospital Boston
^e Department of Pediatrics, Harvard Medical School, Boston, Mass
^f Department of Anesthesia, Harvard Medical School, Boston, Mass
^g Department of Surgery, Harvard Medical School, Boston, Mass.

Received for publication March 5, 2005; revisions received April 20, 2005; accepted for publication April 28, 2005.

^_* Address for reprints: Andrew S. Mackie, MD, SM, Division of Cardiology, The Montreal Children's Hospital, 2300 Tupper St, Montreal, QC, Canada H3H 1P3 (Email: andrew.mackie{at}muhc.mcgill.ca).

OBJECTIVE: This study was undertaken to evaluate the effect of triiodothyronine replacement on the early postoperative course of neonates undergoing aortic arch reconstruction.

METHODS: We performed a randomized, double-blind, placebo-controlled trial of triiodothyronine supplementation in neonates undergoing either a Norwood procedure or two-ventricle repair of interrupted aortic arch and ventricular septal defect. Patients were assigned to receive a continuous infusion of triiodothyronine (0.05 µ/kg/h) or placebo for 72 hours after cardiopulmonary bypass. Primary end points were a composite clinical outcome score and cardiac index at 48 postoperative hours.

RESULTS: We enrolled 42 patients (triiodothyronine n = 22, placebo n = 20). Baseline characteristics were similar in the treatment groups. Study drug was discontinued prematurely because of hypertension (n = 1) and ectopic atrial tachycardia (n = 1), both cases in the triiodothyronine group. Free and total triiodothyronine levels were higher in the triiodothyronine group than in the placebo group at 24, 48, and 72 postoperative hours (P < .001). The median clinical outcome scores were 2.0 (range 0-4) with triiodothyronine and 2.0 (range 0-7) with placebo (P = .046). Compared with those in the placebo group, neonates assigned to triiodothyronine had shorter median time to negative fluid balance (2.0 vs 2.5 days, P = .027). Cardiac index values were 2.11 ± 0.64 L/min·m² with triiodothyronine and 2.05 ± 0.72 L/min·m² with placebo (P = .81). Heart rate and diastolic blood pressure were not influenced by triiodothyronine supplementation, but systolic blood pressure was higher in the triiodothyronine group (P < .001). No serious adverse events were attributed to triiodothyronine administration.

CONCLUSION: Triiodothyronine supplementation was safe and resulted in more rapid achievement of negative fluid balance after aortic arch reconstruction. Cardiac index at 48 hours was not significantly improved.

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