Preemptive Surgical Intervention and Precise Efficacy Evaluation for Hyperparathyroidism Secondary to Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- Safety of preemptive surgical intervention
研究概览
简要总结
Through multi-center randomized controlled trial studies on preemptive surgical intervention in patients with chronic kidney disease (CKD) - secondary hyperparathyroidism (SHPT), to precisely evaluate the safety and effectiveness during perioperative period, and the long-term outcomes by 1-year follow-up. The follow-ups include the evaluation of the overall quality of life, calcium and phosphorus metabolism, hyperparathyroidism level, vitamin D metabolism, bone mineral density, soft tissue and vascular calcification.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic Kidney Disease Stage 3-5d patients aged ≥18 years;
- •The diagnosis is consistent with CKD-metabolic bone disease and SHPT after evaluation by a kidney specialist;
- •Sustained blood immunoreactive parathyroid hormone level of > 300ng/ml, and had received drug treatment;
- •Persistent hypercalcemia and/or hyperphosphatemia that is not responding to medication;
- •Imaging suggested evidence of at least one parathyroid nodular hyperplasia;
- •Signed the informed consent.
排除标准
- •Age <18 years old;
- •Patients with dialysis duration < 3 months, or with other unstable dialysis state;
- •Kidney transplant patients;
- •Who is considered inappropriate to participate in this study after evaluation by the supervising physician.
结局指标
主要结局
Safety of preemptive surgical intervention
时间窗: October 2020 to September 2022
The rate of post operative complications(including bleeding, infection, adjacent tissue injury) of early precise parathyroidectomy surgery in patients with CKD-SHPT, according to the electronic medical records of the hospital.
Efficacy of preemptive surgical intervention
时间窗: October 2020 to September 2022
The rate of relapse of hyperparathyroidism after parathyroidectomy, according to the immunoreactive parathyroid hormone concentration.
次要结局
- Medical Outcomes Short-Form Health Survey (SF36) Scale(October 2020 to September 2022)
- short-term and long-term mortality(October 2020 to September 2022)
- cardiovascular function(October 2020 to September 2022)
- hospitalization costs(October 2020 to September 2022)
- adverse events associated with metabolic bone disease(October 2020 to September 2022)
- short-term and long-term bone metabolism(October 2020 to September 2022)
- inpatient days(October 2020 to September 2022)
研究者
Bo Shen
Attending Physician
Shanghai Zhongshan Hospital