Retrospective Survey of Hyperkalemia in Hemodialysis

• Conditions: Hemodialysis Complication

• Registration Number: NCT05020717
• Lead Sponsor: Peking University People's Hospital

Brief Summary

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

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 Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-17
• Study First Submitted QC: 2021-08-24
• Last Update Submitted: 2021-08-24
• Study First Posted: 2021-08-25
• Last Update Posted: 2021-08-25
• Study Start: 2021-09
• Primary Completion: 2022-08
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To describe hyperkalemia clinical burden on HD facility level	3 years	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
To investigate the risk factors associated with crude mortality on HD facility level	3 years	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)
To describe sK management pattern on HD facility level	3 years	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

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China