Hyperparathyroidism; Secondary, Renal
Conditions
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.
Interventions
PROCEDUREPreemptive Surgical Intervention and Precise Efficacy Evaluation of CKD-SHPT
1. Preemptive surgical intervention for CKD-SHPT patients with poor calcium and phosphorus metabolism controlled by drugs; 2. Rapid immunoreactive parathyroid hormone detection technology during peri-operative period.
Sponsors
Shanghai Zhongshan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of preemptive surgical intervention | 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 | October 2020 to September 2022 | The rate of relapse of hyperparathyroidism after parathyroidectomy, according to the immunoreactive parathyroid hormone concentration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medical Outcomes Short-Form Health Survey (SF36) Scale | October 2020 to September 2022 | 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. |
| cardiovascular function | October 2020 to September 2022 | The left ventricular ejection fraction (%, obtained by echocardiography) during hospitalization, by Day 180 and 1 year during medical visits. |
| short-term and long-term mortality | October 2020 to September 2022 | The all-cause mortality rate and cardiovascular and cerebrovascular mortality rate during hospitalization, by Day 60, Day 180 and 1 year during follow-up. |
| hospitalization costs | October 2020 to September 2022 | Cost of hospitalization, according the electronic medical records. |
| adverse events associated with metabolic bone disease | October 2020 to September 2022 | e.g. fall down, bone fracture during follow-ups, through medical visits and telephone follow-ups. |
| inpatient days | October 2020 to September 2022 | Length of hospitalization, according the electronic medical records. |
| short-term and long-term bone metabolism | October 2020 to September 2022 | 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. |
Contacts
Primary ContactBo Shen, MD
Outcome results
None listed