SZC: Sodium Zirconium Cyclosilicate Lowers Hyperkalemia After Parathyroidectomy

Sponsor

Guangdong Provincial People's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05382988

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Sodium Zirconium Cyclosilicate Hyperkalemia Hyperparathyroidism, Secondary	Drug: Sodium zirconium cyclosilicate	Phase 3

Detailed 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).

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

All patients had dialysis within 24h before PTX, then were treated with PTX in Otolaryngology Head and Neck Surgery department in Guangdong Provincial People's Hospital by one experienced surgeon. The experimental group was required to take SZC 10g immediately after the blood test at 6 am, while no medical treatment was performed on patients in the control group.All patients had dialysis within 24h before PTX, then were treated with PTX in Otolaryngology Head and Neck Surgery department in Guangdong Provincial People's Hospital by one experienced surgeon. The experimental group was required to take SZC 10g immediately after the blood test at 6 am, while no medical treatment was performed on patients in the control group.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Dec 1, 2021

Actual Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Group The experimental group was required to take SZC 10g at 6 am on the day of surgery.	Drug: Sodium zirconium cyclosilicate The experimental group was required to take SZC 10g at 6 am on the day of surgery.
No Intervention: Control Group No additional intervention was performed

Arm

Intervention/Treatment

Experimental: Experimental Group

The experimental group was required to take SZC 10g at 6 am on the day of surgery.

Drug: Sodium zirconium cyclosilicate

The experimental group was required to take SZC 10g at 6 am on the day of surgery.

No Intervention: Control Group

No additional intervention was performed

Outcome Measures

Primary Outcome Measures

Change of serum potassium levels [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.]
Laboratory chemistry measurement

Secondary Outcome Measures

Change of serum calcium levels [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.]
Laboratory chemistry measurement

Other Outcome Measures

Change of parathyroid hormone [Parathyroid hormone were checked 24h before surgery and on the first day after surgery]
Laboratory chemistry measurement

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Guangdong Provincial People's Hospital

Investigators

Principal Investigator: Shuangxin Liu, Ph.D, Guangdong Provincial People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Guangdong Provincial People's Hospital

ClinicalTrials.gov Identifier:

NCT05382988

Other Study ID Numbers:

SZC AFTER PTX

First Posted:

May 19, 2022

Last Update Posted:

May 19, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Neoplasm Metastasis

Hyperkalemia

Hyperparathyroidism

Hyperparathyroidism, Secondary

Study Results

No Results Posted as of May 19, 2022