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临床试验/NCT01872429
NCT01872429已完成不适用

Short- and Long-Term Impact of Subtotal Parathyroidectomy on the Achievement of Bone and Mineral Parameters Recommended by Clinical Practice Guidelines in Dialysis Patients

Far Eastern Memorial Hospital1 个研究点 分布在 1 个国家目标入组 401 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
401
试验地点
1
主要终点
The percentages of cases achieving the recommended K/DOQI and KDIGO targets for bone mineral parameters after subtotal PTx

研究概览

简要总结

The impact of parathyroidectomy (PTX) on the bone mineral parameters in dialysis patients with secondary hyperparathyroidism (SHPT) remains unclear. The investigators performed this study to present the short- and long-term impact of PTX on calcium, phosphorus and intact parathyroid hormone control in dialysis patients with severe SHPT after operation. In particular, the investigators evaluate the impact based on the achievement of recommendations of the current clinical practice guidelines for bone and mineral parameters in dialysis patients after PTX.

详细描述

  1. A retrospective chart review of dialysis patients including referred cases, receiving surgical PTX, which was performed by one surgeon at the Far Eastern Memorial Hospital, a 1084-bed tertiary-care medical center in northern Taiwan will be performed.
  2. Serum levels of calcium, phosphorus and intact parathyroid hormone were routinely measured for three consecutive post-operative days and subsequent laboratory values were checked during out-patient follow-up period. Patients with postoperative 6-month laboratory data are included in the short-term group and those with more than 6-month available data are in the long-term one.
  3. The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI™) Clinical Practice Guidelines provided recommended target values for serum intact parathyroid hormone (iPTH)(150-300 pg/ml), phosphorus (3.5-5.5 mg/dl), calcium (8.4-9.5 mg/dl) and the calcium-phosphorus product (<55 mg2/dl2). The Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guidelines suggested maintaining serum calcium in the reference range (8.5-10.5 mg/dl), phosphorus (2.7-4.5 mg/dl) and PTH values in the range of two to nine times the upper reference limit (130 - 585 pg/ml) in dialysis patients.
  4. The investigators evaluated the impact of subtotal PTX on the control of bone and mineral parameters in dialysis patients with secondary HPT as the percentages of cases achieving the recommended K/DOQI and KDIGO targets.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • dialysis patients
  • secondary hyperparathyroidism refractory to medical treatment
  • patients receiving subtotal parathyroidectomy by one surgeon
  • available laboratory data for at least six months after surgery

排除标准

  • patients receiving parathyroidectomy other than subtotal type by other surgeon
  • available laboratory data less than six months after surgery

结局指标

主要结局

The percentages of cases achieving the recommended K/DOQI and KDIGO targets for bone mineral parameters after subtotal PTx

时间窗: Twelve year period after surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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