Retrospective Survey of Hyperkalemia in Hemodialysis (Visualize-HD)

A Multicenter Retrospective Survey of Hyperkalemia Clinical Burden on Hemodialysis Facility-level in China

This study aim to describe hyperkalemia clinical burden and investigate the risk factors associated with the burden on HD facility level.

Study Overview

• Status: Recruiting
• Conditions: Hemodialysis Complication

Detailed Description

This study is an observational survey study. We estimate 300 hemodialysis (HD) centres will be enrolled in the study. Summarized data on serum potassium (sK) after long interdialytic interval (LIDI), facility practice pattern and patient characteristics which may be related with sK management, and death records information including number of deaths for each centre will be collected. All the data collected and analysed are on HD facility level, not on patient-level. We are aiming to describe hyperkalemia clinical burden and investigate the risk factors associated with the burden on HD facility level. Association between sK management and long-term outcome will also be explored.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Li Zuo; Phone Number: +86(10)88324008; Email: zuoli@bjmu.edu.cn
• Study Contact Backup: Name: Xinju Zhao; Phone Number: +86(10)88325018; Email: zxjrmyy@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Li Zuo; Phone Number: +86(10)88324008; Email: zuoli@bjmu.edu.cn
      • Contact: Baoguo Jiang; Phone Number: +86(10)88324008; Email: jiangbaoguo@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HD centers in China

Description

Inclusion Criteria:

-

For HD centers:

• ≥ 100 patients under MHD within 3 years prior the study initiation
• Willing to participate in the study
• Have routine blood collection after LIDI
• Have death records

For HD patients:

• On chronic HD for ≥ 3 months

Exclusion Criteria:

• Blood test on other days than those after LIDI
• Unable to provide detailed data required by study protocol
• Being unable to comply with study-specified procedure

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate the risk factors associated with hyperkalemia clinical burden on HD facility level	Examine the association of risk factors at current status to hyperkalemia prevalence on HD facility level	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To describe hyperkalemia clinical burden on HD facility level	Constitution ratio of different sK levels after LIDI in ranges: (0, 3.5], (3.5, 5.0], (5.0, 5.5], (5.5, 6.0], (6.0, 6.5], (6.5, 7.0], (7.0~) mmol/L in HD centers	3 years
To describe sK management pattern on HD facility level	Proportion of patients on 3 times/week, 5 times/2 weeks, 2 times/week, less than 2 times/week, and other frequencies of HD treatment Proportion of patients with dialysate potassium concentration at 2.0 mmol/L, 2.5 mmol/L, 3.0 mmol/L and others Proportion of patients with sK testing on monthly, once per 3 months, once per > 3 months and others	3 years
To investigate the risk factors associated with crude mortality on HD facility level	Examine the association of risk factors back to 3 years ago to crude mortality on HD facility level, risk factors back to 3 years ago including: Constitution ratio of different sK levels after LIDI in ranges: (0, 3.5], (3.5, 5.0], (5.0, 5.5], (5.5, 6.0], (6.0, 6.5], (6.5, 7.0], (7.0~) mmol/L in HD centers back to 3 years ago. Constitution ratio of last sK levels before death in ranges: (0, 3.5], (3.5, 5.0], (5.0, 5.5], (5.5, 6.0], (6.0, 6.5], (6.5, 7.0], (7.0~) mmol/L in HD centers Key sK management factors (dialysis frequency, dialysate potassium concentration, sK testing frequency) Other factors (length of dialysis/session, patients dialysis vintage, residual renal function, etiology of ESRD, comorbidities, medication use)	3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate the risk factors associated with sK > 6.0 mmol/L and sK > 6.5 mmol/L on HD facility level	Examine the association of the facility-level risk factors at current status with sK ≥ 6.0 mmol/L and ≥ 6.5 mmol/L	3 years

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Li Zuo, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: August 17, 2021
• First Submitted That Met QC Criteria: August 24, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyperkalemia
• Other Study ID Numbers: 20-20591

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No