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Sodium Zirconium Cyclosilicate Lowers Hyperkalemia After Parathyroidectomy (SZC)

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Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status and phase

Completed
Phase 3

Conditions

Hyperparathyroidism, Secondary
Hyperkalemia
Sodium Zirconium Cyclosilicate

Treatments

Drug: Sodium zirconium cyclosilicate

Study type

Interventional

Funder types

Other

Identifiers

NCT05382988
SZC AFTER PTX

Details and patient eligibility

About

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).

Full 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).

Enrollment

62 patients

Sex

All

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

62 participants in 2 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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