Sodium Zirconium Cyclosilicate Lowers Hyperkalemia After Parathyroidectomy

Hyperkalemia Clinical Trial

— SZC  

Official title:

Effect of Sodium Zirconium Cyclosilicate on Hyperkalemia After Parathyroidectomy in Secondary Hyperparathyroidism Patients With Maintenance Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05382988
• Other study ID #: SZC AFTER PTX
• Status: Completed
• Phase: Phase 3
• Start date: November 2016
• Est. completion date: December 2021

Study information

• Verified date: April 2022
• Source: Guangdong Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sodium zirconium cyclosilicate (SZC) has been demonstrated for its serum potassium-lowering efficacy and safety in hyperkalemia hemodialysis patients.

However, the effects of SZC during the perioperative period remained unknown.

This experiment aimed to determine whether using SZC would impact the serum potassium levels in patients with maintenance hemodialysis after parathyroidectomy (PTX).

Description:

Secondary Hyperparathyroidism (SHPT) is a common and severe manifestation of chronic kidney disease (CKD), especially in end-stage renal disease (ESRD) patients. SHPT is characterized by elevated parathyroid hormone (PTH) synthesis and secretion accompanied by parathyroid cell hyperplasia.Elevated PTH level is considered as a risk factor for fracture, hyperphosphatemia, anemia, and cardiovascular calcification that worsens the health-related quality of life and increases mortality.

Parathyroidectomy (PTX) has been considered the first-line treatment for severe SHPT. Generally, approximately 29% of patients with end-stage renal disease undergo parathyroidectomy to control secondary hyperparathyroidism. Successful PTX may rapidly reduce serum PTH levels and alleviate clinical symptoms.

Postoperative hyperkalemia is one common complication after PTX. With an incidence of 25-80%, in previous research, hyperkalemia has been reported during and immediately after PTX, leading to devastating consequences.

SZC increases fecal potassium excretion and lowers serum potassium levels by binding potassium ions, demonstrated to reduce serum potassium to normal levels within 48 hours in hyperkalemia patients.

Nevertheless, the effects of SZC during the perioperative period remained unknown.

Sixty-two patients with secondary hyperparathyroidism (SHPT) were randomly recruited into the experimental and control groups. Patients in the experimental group were required to take SZC 10g before PTX. Laboratory chemistries, including serum potassium levels, serum calcium levels and serum PTH were obtained before and after surgery. We aimed to determine whether using SZC would impact the serum potassium levels in patients with maintenance hemodialysis after parathyroidectomy (PTX).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Secondary Hyperparathyroidism (SHPT) is a common and severe manifestation of chronic kidney disease (CKD), especially in end-stage renal disease (ESRD) patients. ESRD MHD with SHPT patients were recruited into this study

Exclusion Criteria:

• Patients with severe cardiovascular disease who cannot tolerate general anesthesia surgery were not included in this study.

Related Conditions & MeSH terms

• Hyperkalemia
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Neoplasm Metastasis

Intervention

Drug:
• Sodium zirconium cyclosilicate
The experimental group was required to take SZC 10g at 6 am on the day of surgery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of parathyroid hormone	Laboratory chemistry measurement	Parathyroid hormone were checked 24h before surgery and on the first day after surgery
Primary	Change of serum potassium levels	Laboratory chemistry measurement	Serum potassium levels were checked at three time points, which were t0 (6 am on the day of surgery), t1 (immediate after surgery), and t2 (9 pm on the day of surgery), respectively.
Secondary	Change of serum calcium levels	Laboratory chemistry measurement	Serum calcium levels were checked at three time points, which were t0 (6 am on the day of surgery), t1 (immediate after surgery), and t2 (9 pm on the day of surgery), respectively.