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Research on the Application of Chronic Kidney Disease Patient Sodium Management Software: A Multi-Center, Follow-up Parallel Control Clinical Study

Evaluating the Efficacy and Safety of Physiological Parameter Management Software in Chronic Kidney Disease Patients : A Multi-Center, Randomized Parallel Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070616
Enrollment
Unknown
Registered
2023-04-18
Start date
2023-04-21
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

chronic kidney disease

Interventions

Intervention group:1. Conducting routine patient management, conducting education from D-1 to D1 (before intervention), with the same content as the control group. 2. Intervention using the Chronic Ki
control group:patient education on nutritional knowledge on the intake of sodium and salt in daily diet

Sponsors

Sichuan University West China Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: a)be aged 18 or older; b)diagnosis of CKD and 24-hour urine volume > 400 mL; c)the sodium excretion of >=100 mmol/d in at least two consecutive urine samples, or a single excretion value of >=130 mmol/d within the screening period; d)cognitive function must be assessed as normal using the Mini-Cog test; e)understanding the procedures and methods of this study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: a)Those with unstable renal function such as acute kidney injury or obstructive nephropathy. b)Those who have received hemodialysis, peritoneal dialysis, or kidney transplantation. c)Those with diseases that can cause rapid decline in renal function, such as vasculitis, lupus, etc. d)Those with SBP>180 mmHg and/or DBP>100 mmHg after treatment with antihypertensive drugs. e)Combination of other serious underlying diseases which, in the opinion of the investigator, are likely to increase the risk of the trial, affect the subject's compliance with the protocol, or affect the subject's ability to complete the trial, including but not limited to malignancy (excluding tumors without evidence of disease recurrence within 6 months prior to screening), severe cardiovascular and cerebrovascular disease, and neurological and psychiatric disorders. f)Those randomized to a period of time shorter than 5 half-lives of the drug or duration of drug efficacy (whichever is longest) from the last use of diuretics and diuretic-containing combination drugs. g)Those who have participated in any other clinical study within 1 month prior to screening. h)Those whom, in the opinion of the investigator, have any other factors that make participation in this clinical study inappropriate.

Design outcomes

Primary

MeasureTime frame
24h urinary excretion of sodium;

Secondary

MeasureTime frame
blood pressure;the score of salt restriction diet;the quality of life scores;

Countries

China

Contacts

Public ContactYun-ying SHI

Department of Nephrology Sichuan University West China Hospital

yyshi0130@163.com+86 18980605862

Outcome results

None listed

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