Influencing Factors of Cerebrovascular Disease and Cognition in Hemodialysis Patients

Cognitive Impairment Clinical Trial

Official title:

Influencing Factors of Cerebrovascular Disease and Cognition in Hemodialysis Patients: an Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04433455
• Other study ID #: KY2019-465
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: May 31, 2025

Study information

• Verified date: February 2024
• Source: Huashan Hospital
• Contact: Jing Chen
• Phone: 862152889325
• Email: chenjing1998[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this observational study, the investigators evaluate the influencing factors of cerebrovascular disease and cognition in hemodialysis patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

1. maintenance hemodialysis patients who are younger than 85 years old and older than 50 years old, regardless of gender

2. dialysis vintage is greater than 3 months;

Exclusion Criteria:

1. Those with severe infection and anemia (Hb <60g / L);

2. Those with severe mental illness, metabolic diseases and immune system diseases;

3. Patients with abnormal liver function

Related Conditions & MeSH terms

• Cerebrovascular Disorders
• Cognitive Impairment
• Hemodialysis

Locations

Country	Name	City	State
China	Huashan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cerebrovascular disease	Magnetic resonance images will be used to determine the severity of white matter hyperintensity, using the Scheltens scale. Score 2 or more is abnormal.	5 years
Secondary	changes in cognitive function	The Mini-Mental State Examination (MMSE) will be used to assess the changes in cognitive function.The MMSE has a maximum score of 30 points. The scores are generally grouped as follows: 25-30 points: normal cognition 21-24 points: mild dementia 10-20 points: moderate dementia 9 points or lower: severe dementiaThe Mini-Mental State Examination (MMSE) will be used to assess the changes in cognitive function.The MMSE has a maximum score of 30 points. The scores are generally grouped as follows: 25-30 points: normal cognition 21-24 points: mild dementia 10-20 points: moderate dementia 9 points or lower: severe dementia	5 years