search
Back to results

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
Guangdong Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sodium Zirconium Cyclosilicate

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

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

    First Posted
    May 9, 2022
    Last Updated
    May 16, 2022
    Sponsor
    Guangdong Provincial People's Hospital
    search

    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

    Learn more about this trial

    Sodium Zirconium Cyclosilicate Lowers Hyperkalemia After Parathyroidectomy

    We'll reach out to this number within 24 hrs