Sodium Zirconium Cyclosilicate Lowers Hyperkalemia After Parathyroidectomy

NCT05382988 | Completed Phase 3

• 1 other identifier: SZC AFTER PTX
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Sodium Zirconium Cyclosilicate; Hyperkalemia; Hyperparathyroidism, Secondary

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Other Outcomes (1)

• Change of parathyroid hormone

  Parathyroid hormone were checked 24h before surgery and on the first day after surgery

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Drug: Sodium zirconium cyclosilicate

Control Group

NO INTERVENTION

No additional intervention was performed

Interventions

Sodium zirconium cyclosilicate DRUG

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

Experimental Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Related Publications (1)

• Kang J, Li S, Su J, Xiao Z, Zhang S, Liu S, Ge P. Effect of sodium zirconium cyclosilicate on hyperkalemia after parathyroidectomy in secondary hyperparathyroidism patients with maintenance hemodialysis: A randomized trial. Medicine (Baltimore). 2024 Dec 27;103(52):e40917. doi: 10.1097/MD.0000000000040917.

  PMID: 39969301 DERIVED

MeSH Terms

Conditions

Hyperkalemia; Hyperparathyroidism, Secondary

Interventions

sodium zirconium cyclosilicate

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Shuangxin Liu, Ph.D

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 19, 2022
• Study Start: November 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share