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临床试验/NCT04523974
NCT04523974Unknown不适用

Preemptive Surgical Intervention and Precise Efficacy Evaluation for Hyperparathyroidism Secondary to Chronic Kidney Disease

Shanghai Zhongshan Hospital0 个研究点目标入组 50 人开始时间: 2020年10月1日最近更新:
适应症

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

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

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bo Shen

Attending Physician

Shanghai Zhongshan Hospital

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Preemptive and Precise Intervention for CKD-SHPT | 临床试验