NCT05623033RecruitingNot Applicable
The Predictive Value of Dynamic Changes of CD4+T Lymphocytes in Primary Nephrotic Syndrome With Infection
Fifth Affiliated Hospital, Sun Yat-Sen University1 site in 1 country156 target enrollmentStarted: November 16, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- Dynamic changes of CD4+T cells
Study Overview
Brief Summary
The goal of this observational study is to test whether the dynamic changes of CD4+T lymphocytes can predict infections in patients with primary nephrotic syndrome . The main questions it aims to answer are:
- whether the dynamic changes of CD4+T lymphocytes can predict infections in patients with primary nephrotic syndrome
- effect of different immunosuppressive therapy on the number and function of T lymphocyte subsets in patients with primary nephrotic syndrome
Participants will be divided into infection group and non-infection group according to whether they are infected
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 14 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age ≥ 14 years and<75 years.
- •It meets the diagnostic criteria of primary nephrotic syndrome, i.e. a. A large amount of proteinuria (24h urine protein quantity > 3.5g/d); b. Hypoalbuminemia (liver function: albumin<30g/L); c. Edema; d. The blood lipid is elevated. Among them, item a and b are necessary conditions for diagnosis.
- •Nephrocentesis pathology indicates the pathological type of nephrotic syndrome (minimal change glomerulonephritis, membranous nephropathy, focal segmental glomerulonephritis, membranous proliferative glomerulonephritis, mesangial proliferative glomerulonephritis).
- •Glucocorticoids or corticosteroids combined with immunosuppressants should be used clinically.
Exclusion Criteria
- •Secondary nephrotic syndrome, such as secondary to systemic lupus erythematosus, hepatitis B, hepatitis C, tumor, organic solvent , heavy metal poisoning, etc.
- •Patients with tumor and chronic infectious diseases, such as HIV infection, cardiac insufficiency, acute hepatitis, transaminase increase more than twice the normal value, deep vein thrombosis.
- •The subjects were pregnant and lactating women.
- •Patients with serious primary diseases such as heart, brain, liver and hematopoietic system.
- •Those who can not cooperate, such as the mentally ill.
- •It is known that it is allergic to or has contraindications to any component in glucocorticoid, FK506, MMF and CTX.
- •Serum creatinine (SCR) > 265.2 μ mol/L（3mg/dl）。
Outcomes
Primary Outcomes
Dynamic changes of CD4+T cells
Time Frame: 3 years after the project starts
Whether the change of CD4+T lymphocytes count can predict infections in patients with primary nephrotic syndrome
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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