Integrated Diagnosis and Treatment of CKD on Outcomes

Hypertension Clinical Trial

Official title:

A Prospective, Cohort, and Observational Study of the Effect of Integrated Diagnosis and Treatment of Chronic Kidney Disease (CKD) on Clinical Outcomes in Real World Clinical Practice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05242055
• Other study ID #: 202112-11
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2022
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Objective: To establish a study cohort and follow up of patients with CKD in our hospital, and evaluate the status of integrated CKD diagnosis and treatment according to guidelines in the real world, as well as the clinical prognosis of patients with different stratification.

Methods: By establishing a cohort of 1000 patients with CKD and conducting long-term follow-up, integrated diagnosis and treatment for CKD was performed, namely: Regular monitoring, control of blood pressure, blood glucose, blood lipid, correction of anemia, minerals - bone metabolic abnormalities, malnutrition, acid and alkali, and electrolyte disorder, diet and exercise, such as the guidance of integrated management, non intrusive, observational studies, prospective cohort were analyzed retrospectively, describe the implementation of the integration of diagnosis and treatment, chronic kidney disease (CKD) Stratified analysis and risk factor analysis were performed for cardiovascular disease and other main endpoint events, so as to objectively reflect the status of integrated treatment of CKD and provide data support for continuous quality improvement of CKD diagnosis and treatment and improvement of clinical prognosis of patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• =18 years old;

• Voluntarily signed informed consent;

• Patients who are estimated to develop CKD.

Exclusion Criteria:

• Age < 18 or =100 years;

• Unable to comply with the procedures stipulated in this study;

• Estimated follow-up time =6 months.

Related Conditions & MeSH terms

• Anemia
• Bone Diseases
• Chronic Kidney Disease-Mineral and Bone Disorder
• Chronic Kidney Diseases
• Hyperglycemia
• Hyperlipidemias
• Hypertension
• Kidney Diseases
• Malnutrition
• Renal Insufficiency, Chronic

Intervention

Other:
• Integrated diagnosis and treatment for CKD
This is an observational study. Investor will not intervene the clinical practice of doctors. In the real world, there would be many factors affect the proceeding of the guidelines contents. There will be integrated diagnosis and treatment during follow-up.

Locations

Country	Name	City	State
China	Nephrology Department of Beijing Jishuitan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of cardiovascular cerebrovascular adverse events	Acute myocardial infarction, heart failure, shock, cardiac arrest, stroke, and lower limb arterial occlusion occurred during follow-up	Six months or more
Secondary	Rate of all-cause mortality	Deaths from all causes during follow-up	Six months or more