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Cognitive Outcomes Prediction Evaluation (COPE) Study: Based on a Cohort of Chronic Kidney Disease Patients

Cognitive Outcomes Prediction Evaluation (COPE) Study: Based on a Cohort of Chronic Kidney Disease Patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000035328
Enrollment
Unknown
Registered
2020-08-08
Start date
2020-11-01
Completion date
Unknown
Last updated
2020-08-10

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

Conditions

mild cognitive impairment

Interventions

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Sponsors

The First Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-80 years; (2) CKD patients: eGFR = 30mg/d or urine albumin-creatinine ratio ACR >= 30mg/g); or both are consistent. Hemodialysis patients: should maintain hemodialysis for more than 3 months; (3) The life expectancy exceeds 6 months; (4) Sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Poor compliance, unable to follow up on schedule; (2) Are participating in interventional clinical trials; (3) Dementia or other mental and cognitive disorders, limited physical activity, severe visual impairment, etc. cannot cooperate to complete the assessment; (4) The expected survival period is less than 6 months; (5) Severe cardiac insufficiency (NYHA grade III or IV heart failure, that is, basic heart disease, obvious limitation of physical activity, fatigue, palpitations, wheezing or angina can occur under normal physical activity or even at rest); (6) The diagnosis of CKD is and only simple hematuria: that is, centrifugal urine sediment microscopy shows that red blood cells are >= 3/high-powered field of view, and it is glomerular-derived hematuria (mainly abnormal red blood cells). Without hypertension, proteinuria (including microalbuminuria) and eGFR >= 60mL/min/1.73m2. Exclude urinary tract infections, tumors, drugs and other factors that cause false positives; (7) Acute kidney injury (AKI) patients, that is, serum creatinine rises >= 0.3mg/dl within 48 hours; or serum creatinine exceeds 1.5 times the baseline value within 7 days; or urine output < 0.5ml/kg/ h is greater than 6 hours; (8) Acute disease state: such as infection, fever, acute coronary syndrome, etc.; or during the acute attack of chronic disease; (9) HIV infection or AIDS.

Design outcomes

Primary

MeasureTime frame
RT;Blood chemistry;Serum Cystatin C;Homocysteine;Full parathyroid hormone;High sensitivity C-reactive protein;Glycated hemoglobin;25(OH)VitD3;Alkaline phosphatase;Folic acid;VitB12;Serum Fe;Serum ferritin;Urine routine;24h urine biochemistry;Urine albumin/creatinine ratio;SEN, SPE, ACC, AUC of ROC, PPV, NPV.;

Countries

China

Contacts

Public ContactXiaohua Pei

The First Affiliated Hospital of Nanjing Medical University

agingckd_mci@163.com+86 13951744934

Outcome results

None listed

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