Preemptive Surgical Intervention and Precise Efficacy Evaluation for Hyperparathyroidism Secondary to Chronic Kidney Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hyperparathyroidism; Secondary, Renal
- Sponsor
- Shanghai Zhongshan Hospital
- Enrollment
- 50
- Primary Endpoint
- Safety of preemptive surgical intervention
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Bo Shen
Attending Physician
Shanghai Zhongshan Hospital
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Safety of preemptive surgical intervention
Time Frame: 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
Time Frame: October 2020 to September 2022
The rate of relapse of hyperparathyroidism after parathyroidectomy, according to the immunoreactive parathyroid hormone concentration.
Secondary Outcomes
- 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)