Preemptive and Precise Intervention for CKD-SHPT

Study Overview
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Brief Summary
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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.

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

Conditions
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Hyperparathyroidism; Secondary, Renal

Intervention / Treatment
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* Procedure: Preemptive Surgical Intervention and Precise Efficacy Evaluation of CKD-SHPT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) Chronic Kidney Disease Stage 3-5d patients aged ≥18 years; 2) The diagnosis is consistent with CKD-metabolic bone disease and SHPT after evaluation by a kidney specialist; 3) Sustained blood immunoreactive parathyroid hormone level of > 300ng/ml, and had received drug treatment; 4) Persistent hypercalcemia and/or hyperphosphatemia that is not responding to medication; 5) Imaging suggested evidence of at least one parathyroid nodular hyperplasia; 6) Signed the informed consent. Exclusion Criteria: 1) Age <18 years old; 2) Patients with dialysis duration < 3 months, or with other unstable dialysis state; 3) Kidney transplant patients; 4) Who is considered inappropriate to participate in this study after evaluation by the supervising physician.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preemptive and Precise Intervention<br>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. | Procedure: Preemptive Surgical Intervention and Precise Efficacy Evaluation of CKD-SHPT<br>* Preemptive surgical intervention for CKD-SHPT patients with poor calcium and phosphorus metabolism controlled by drugs; Rapid immunoreactive parathyroid hormone detection technology during peri-operative period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |