Sodium Zirconium Cyclosilicate Lowers Hyperkalemia After Parathyroidectomy (SZC)
Primary Purpose
Sodium Zirconium Cyclosilicate, Hyperkalemia, Hyperparathyroidism, Secondary
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Sodium zirconium cyclosilicate
Sponsored by
About this trial
This is an interventional treatment trial for Sodium Zirconium Cyclosilicate
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental Group
Control Group
Arm Description
The experimental group was required to take SZC 10g at 6 am on the day of surgery.
No additional intervention was performed
Outcomes
Primary Outcome Measures
Change of serum potassium levels
Laboratory chemistry measurement
Secondary Outcome Measures
Change of serum calcium levels
Laboratory chemistry measurement
Full Information
NCT ID
NCT05382988
First Posted
May 9, 2022
Last Updated
May 16, 2022
Sponsor
Guangdong Provincial People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05382988
Brief Title
Sodium Zirconium Cyclosilicate Lowers Hyperkalemia After Parathyroidectomy
Acronym
SZC
Official Title
Effect of Sodium Zirconium Cyclosilicate on Hyperkalemia After Parathyroidectomy in Secondary Hyperparathyroidism Patients With Maintenance Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
December 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Provincial People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. 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).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sodium Zirconium Cyclosilicate, Hyperkalemia, Hyperparathyroidism, Secondary
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
The experimental group was required to take SZC 10g at 6 am on the day of surgery.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No additional intervention was performed
Intervention Type
Drug
Intervention Name(s)
Sodium zirconium cyclosilicate
Intervention Description
The experimental group was required to take SZC 10g at 6 am on the day of surgery.
Primary Outcome Measure Information:
Title
Change of serum potassium levels
Description
Laboratory chemistry measurement
Time Frame
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 Outcome Measure Information:
Title
Change of serum calcium levels
Description
Laboratory chemistry measurement
Time Frame
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.
Other Pre-specified Outcome Measures:
Title
Change of parathyroid hormone
Description
Laboratory chemistry measurement
Time Frame
Parathyroid hormone were checked 24h before surgery and on the first day after surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuangxin Liu, Ph.D
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Sodium Zirconium Cyclosilicate Lowers Hyperkalemia After Parathyroidectomy
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