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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preemptive and Precise Intervention | Preemptive surgical intervention will be performed on enrolled CKD-SHPT patients. Safety and efficacy of this intervention will be evaluated during peri-operative period, and long-term outcomes will be analyzed during 1-year follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preemptive Surgical Intervention and Precise Efficacy Evaluation of CKD-SHPT | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of preemptive surgical intervention | 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. | October 2020 to September 2022 |
| Efficacy of preemptive surgical intervention | The rate of relapse of hyperparathyroidism after parathyroidectomy, according to the immunoreactive parathyroid hormone concentration. | October 2020 to September 2022 |
| Measure | Description | Time Frame |
|---|---|---|
| short-term and long-term mortality | The all-cause mortality rate and cardiovascular and cerebrovascular mortality rate during hospitalization, by Day 60, Day 180 and 1 year during follow-up. | October 2020 to September 2022 |
| short-term and long-term bone metabolism |
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Inclusion Criteria:
Exclusion Criteria:
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CKD 3-5d patients with the diagnosis of CKD-metabolic bone disease and SHPT, with sustained blood immunoreactive parathyroid hormone level of > 300ng/ml, and persistent hypercalcemia and/or hyperphosphatemia, which are not responding to medication.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo Shen, MD | Contact | +86 13564608233 | shen.bo@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Bo Shen, MD | Fudan University | Principal Investigator |
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| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
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blood samples will be collected to evaluate the level of immunoreactive parathyroid hormone, 25(OH)Vitamin D, calcium, phosphate, alkaline phosphatase and biomarker series of osteogenic collagen metabolism and transformation.
|
The level of immunoreactive parathyroid hormone, 25(OH)-vitamin D, calcium, phosphate, alkaline phosphatase and biomarker series of bone metabolism during hospitalization, by Day 60, Day 180 and 1 year. |
| October 2020 to September 2022 |
| Medical Outcomes Short-Form Health Survey (SF36) Scale | Medical Outcomes Short-Form Health Survey (SF36) scale on quality of life during hospitalization, by Day 60, Day 180 and 1 year during follow-ups. The minimum value is 0, and the maximum value is 100, and higher scores mean a better outcome. | October 2020 to September 2022 |
| cardiovascular function | The left ventricular ejection fraction (%, obtained by echocardiography) during hospitalization, by Day 180 and 1 year during medical visits. | October 2020 to September 2022 |
| inpatient days | Length of hospitalization, according the electronic medical records. | October 2020 to September 2022 |
| hospitalization costs | Cost of hospitalization, according the electronic medical records. | October 2020 to September 2022 |
| adverse events associated with metabolic bone disease | e.g. fall down, bone fracture during follow-ups, through medical visits and telephone follow-ups. | October 2020 to September 2022 |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |