High-dose preoperative cholecalciferol to prevent post-thyroidectomy hypocalcaemia: A randomized, double-blinded placebo-controlled trial
Rowe CW, Arthurs S, O'Neill CJ, Hawthorne J, Carroll R, Wynne K, Bendinelli C
Clinical endocrinology · 15 citas
Etiquetas de revisión
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2018-11-02 · Clin Endocrinol (Oxf) · vol. 90 · número 2 · págs. 343–350
- Editorial
- Wiley
- Citado
- 24 citas · más que el 81% de estudios similares · 1.3× el promedio de su campo
- Referencias
- 20 trabajos
- Acceso
- De pago
- Áreas de investigación
- Thyroid and Parathyroid Surgery · Parathyroid Disorders and Treatments · Uterine Myomas and Treatments
- Palabras clave
- Hypocalcaemia, Medicine, Cholecalciferol, Placebo, Thyroidectomy, Vitamin D and neurology, Internal medicine, Gastroenterology, vitamin D deficiency, Surgery, Endocrinology, Thyroid, Calcium, Pathology
- MeSH
- humans, hypocalcemia, cholecalciferol, treatment outcome, premedication, preoperative care, thyroidectomy, adult, middle aged, female, male, calcium-regulating hormones and agents
7 autores
- Christopher W. Rowe🇦🇺John Hunter Hospital; University of Newcastle Australia
- Sam Arthurs🇦🇺John Hunter Hospital
- Christine J. O’Neill🇦🇺John Hunter Hospital; University of Newcastle Australia
- Jacqueline Hawthorne🇦🇺John Hunter Hospital
- Rosemary Carroll🇦🇺John Hunter Hospital
- Katie Wynne🇦🇺John Hunter Hospital; University of Newcastle Australia
- Cino Bendinelli🇦🇺 · autor de correspondenciaJohn Hunter Hospital
Resumen
El texto original del estudio, en el idioma en que se publicó.
Objective
Post-thyroidectomy hypocalcaemia is a significant cause of morbidity and prolonged hospitalization, usually due to transient parathyroid gland damage, treated with calcium and vitamin D supplementation. We present a randomized, double-blinded placebo-controlled trial of preoperative loading with high-dose cholecalciferol (300 000 IU) to reduce post-thyroidectomy hypocalcaemia.
Patients and measurements
Patients (n = 160) presenting for thyroidectomy at tertiary hospitals were randomized 1:1 to cholecalciferol (300 000 IU) or placebo 7 days prior to thyroidectomy. Ten patients withdrew prior to surgery. The primary outcome was post-operative hypocalcaemia (corrected calcium <2.1 mmol/L in first 180 days).
Results
The study included 150 patients undergoing thyroidectomy for Graves' disease (31%), malignancy (20%) and goitre (49%). Mean pre-enrolment vitamin D was 72 ± 26 nmol/L. Postoperative hypocalcaemia occurred in 21/72 (29%) assigned to cholecalciferol and 30/78 (38%) participants assigned to placebo (P = 0.23). There were no differences in secondary end-points between groups. In pre-specified stratification, baseline vitamin D status did not predict hypocalcaemia, although most individuals were vitamin D replete at baseline. Post-hoc stratification by day 1 parathyroid hormone (PTH) (<10 pg/mL, low vs ≥10 pg/mL, normal) was explored due to highly divergent rates of hypocalcaemia in these groups. Using a Cox regression model, the hazard ratio for hypocalcaemia in the cholecalciferol group was 0.56 (95%CI 0.32-0.98, P = 0.04) after stratification for Day 1 PTH. Further clinical benefits were observed in these subgroups.
Conclusions
Pre-thyroidectomy treatment with high-dose cholecalciferol did not reduce the overall rate of hypocalcaemia following thyroidectomy. In subgroups stratified by day 1 PTH status, improved clinical outcomes were noted.
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