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Clinical study on dialysis patients with end-stage renal disease and oral microflora

Clinical study on dialysis patients with end-stage renal disease and oral microflora

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400079717
Enrollment
Unknown
Registered
2024-01-10
Start date
2023-03-08
Completion date
Unknown
Last updated
2024-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage renal disease

Interventions

Maintenance hemodialysis group:Observational study, no intervention.
Maintenance hemodialysis combined with heart failure group:Observational study, no intervention.
Control group:Observational study, no intervention.

Sponsors

The First Affiliated Hospital, Xi'an Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 87 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for maintenance hemodialysis group: 1. Over 18 years old; 2. Receive hemodialysis treatment for 1 year or more (3 times a week for more than 4 hours each time); 3. Sign the informed consent form. Inclusion criteria for maintenance hemodialysis combined with heart failure group: 1. Over 18 years old; 2. Receive hemodialysis treatment for 1 year or more (3 times a week for more than 4 hours each time); 3. heart failure diagnosis in accordance with the Chinese Guidelines for the Diagnosis and Treatment of Heart Failure (2018) with reduced ejection fraction (heart failure with preserved ejection (HFpEF) : 1) have symptoms and/or signs of heart failure; 2) Left ventricular ejection fraction (LVEF) < 40%. 4. Sign the informed consent form. Control group inclusion criteria: 1. No obvious disease; 2. Age, sex and case group matched; 3. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion criteria for maintenance hemodialysis group: 1. Kidney transplant patients; 2. Pregnant patients; 3. Receiving antibiotics within the past 3 months; 4. History of infectious diseases in the past 3 months; 5. Have received periodontal treatment in the past 1 year; 6. Unable to obtain informed consent. Exclusion criteria for maintenance hemodialysis combined with heart failure: 1. Kidney transplant patients; 2. Pregnant patients; 3. Receiving antibiotics within the past 3 months; 4. History of infectious diseases in the past 3 months; 5. Have received periodontal treatment in the past 1 year; 6. Unable to obtain informed consent; 7. heart failure with preserved ejection fraction (HFpEF) according to Chinese Guidelines for the Diagnosis and Treatment of Heart Failure (2018) : 1) have symptoms and/or signs of heart failure; 2) LVEF=50%; 3) Increased natriuretic peptides consistent with at least one of the following: ? left ventricular hypertrophy and/or left atrial enlargement; ? abnormal ventricular diastolic function. 8. heart failure with mid-range ejection fraction (HFmrEF) in the Chinese Guidelines for the Diagnosis and Treatment of Heart Failure (2018) : 1) have symptoms and/or signs of heart failure; 2) LVEF 40% ~ 49%; 3) Increased natriuretic peptides consistent with at least one of the following: ? left ventricular hypertrophy and/or left atrial enlargement; ? abnormal ventricular diastolic function. Control group exclusion criteria: 1. Pregnant and lactating women; 2. Lifestyle that significantly affects the microbiota, such as taking drugs in the past month, including antibiotics, metformin, statins, probiotics, and prebiotics; Eat yogurt more than 3 times a week in the past month; Heavy drinking in the past week (drinking more than 4 glasses of white wine at a time, drinking more than 1000ml of beer), or drinking every week in the past three months.

Design outcomes

Primary

MeasureTime frame
Oral microflora;

Secondary

MeasureTime frame
Oral periodontal status examination and score;

Countries

China

Contacts

Public ContactLi Lu

The First Affiliated Hospital, Xi'an Medical University

liluwenqi@163.com+86 153 9940 8990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026