Preemptive and Precise Intervention for CKD-SHPT

Hyperparathyroidism; Secondary, Renal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04523974
• Other study ID #: PP-CKD-SHPT
• Status: Not yet recruiting
• Start date: October 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2020
• Source: Shanghai Zhongshan Hospital
• Contact: Bo Shen, MD
• Phone: +86 13564608233
• Email: shen.bo[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Hyperparathyroidism; Secondary, Renal
• Neoplasm Metastasis

Intervention

Procedure:
• Preemptive Surgical Intervention and Precise Efficacy Evaluation of CKD-SHPT
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	inpatient days	Length of hospitalization, according the electronic medical records.	October 2020 to September 2022
Secondary	hospitalization costs	Cost of hospitalization, according the electronic medical records.	October 2020 to September 2022
Secondary	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