Study of post-total thyroidectomy hypocalcemia after preoperative cholecalciferol supplementation.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Hopital NOVO
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Measure of the occurrence of serum and / or clinical hypocalcemia Serum hypocalcemia is defined by a level of calcemia, corrected for albuminemia, of less than 2.00 mmol / L. Clinical hypocalcemia is defined by the appearance of one of the following signs: sign of Chvostek, sign of Trousseau, paresthesias of the extremities and perioral between surgery and D15
研究概览
简要总结
Assessment of the effect of pre-operative cholecalciferol supplementation on the occurrence of post-operative hypocalcemia aftertotal thyroidectomy
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patient ≥ 18 years old
- •Patient shall be operated on for a total thyroidectomy in one time for any indication
- •Written informed consent (IC) obtained
- •Patients with affiliation to the social security system
排除标准
- •Medical history of : thyroid or parathyroid surgery, Hyperparathyroidism , granulomatosis flare-up
- •Pregnant women
- •Vulnerable populations (guardianship or trusteeship)
- •Persons deprived of their liberty by court or administrative decision
- •Chronic kidney disease grade ≥4
- •25OHD supplementation within last 3 months before surgery
- •Malabsorption syndrome
- •Known hypersensitivity to vitamin D
- •Allergies to one of the components of the fruit juice
- •Medical history of calcic lithiasis
- •Hypocalcemia, hypercalcemia/ hypercalciuria, or symptom of Hypocalcemia, hypercalcemia/ hypercalciuria, not due to thyroid pathologies
- •Severe liver failure
结局指标
主要结局
Measure of the occurrence of serum and / or clinical hypocalcemia Serum hypocalcemia is defined by a level of calcemia, corrected for albuminemia, of less than 2.00 mmol / L. Clinical hypocalcemia is defined by the appearance of one of the following signs: sign of Chvostek, sign of Trousseau, paresthesias of the extremities and perioral between surgery and D15
Measure of the occurrence of serum and / or clinical hypocalcemia Serum hypocalcemia is defined by a level of calcemia, corrected for albuminemia, of less than 2.00 mmol / L. Clinical hypocalcemia is defined by the appearance of one of the following signs: sign of Chvostek, sign of Trousseau, paresthesias of the extremities and perioral between surgery and D15
次要结局
- Duration of initial hospitalization (number of hospital days), collect of adverse events and number of readmissions
- Measure of severity of hypocalcemia defined by a calcemia corrected for albuminemia of less than 1.90 mmol / L and / or the use of calcium gluconate IV in the first 15 post-operative days.
- Measure of duration of hypocalcemia's symptoms in the first 15 days postoperative
- Vitamin D deficiency will be measured by comparing the initial value of 25OHD at the inclusion visit to the value of 25OHD of the day of the operation (D0=H0)
- Collect of the number of adverse events and serum calcium levels for each participant
- Collect of the definitive hypocalcemia's numbers in each group
- Parathyroid activity will be evaluated in both group by measuring parathormone (PTH). Hypoparathyroidism being defined by PTH < 15 ng / L.
研究者
AL TABAA Khaled
Scientific
Hopital NOVO