Retrospective Survey of Hyperkalemia in Hemodialysis

Hemodialysis Complication Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05020717
• Other study ID #: 20-20591
• Status: Recruiting
• Start date: September 2021
• Est. completion date: December 2022

Study information

• Verified date: August 2021
• Source: Peking University People's Hospital
• Contact: Li Zuo
• Phone: +86(10)88324008
• Email: zuoli[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis Complication
• Hyperkalemia

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University People's Hospital	AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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