Preemptive and Precise Intervention for CKD-SHPT

• Conditions: Hyperparathyroidism; Secondary, Renal
• Interventions: Procedure: Preemptive Surgical Intervention and Precise Efficacy Evaluation of CKD-SHPT

• Registration Number: NCT04523974
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-17
• Study First Submitted QC: 2020-08-19
• Last Update Submitted: 2020-08-19
• Study First Posted: 2020-08-24
• Last Update Posted: 2020-08-24
• Study Start: 2020-10-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preemptive and Precise Intervention	Preemptive Surgical Intervention and Precise Efficacy Evaluation of CKD-SHPT	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.
inpatient days	October 2020 to September 2022	Length of hospitalization, according the electronic medical records.