Preemptive and Precise Intervention for CKD-SHPT

Shanghai Zhongshan Hospital50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hyperparathyroidism; Secondary, Renal

Interventions

Preemptive Surgical Intervention and Precise Efficacy Evaluation of CKD-SHPTPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.