Integrated Diagnosis and Treatment of CKD on Outcomes

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hyperglycemia; Hypertension; Chronic Kidney Diseases; Anemia; Malnutrition; Hyperlipidemias; Chronic Kidney Disease-Mineral and Bone Disorder
• Intervention / Treatment: Other: Integrated diagnosis and treatment for CKD

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100035
      • Recruiting
      • Nephrology Department of Beijing Jishuitan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with CKD following up more than 6 months in Beijing Jishuitan Hospital.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Integrated group; Patients in the integrated group should be the patients getting integrated diagnosis and treatment during following up period. Integrated diagnosis and treatment includes control of hypertension, hyperglycemia, hyperlipidemia, anemia, CKD-MBD, and malnutrition by regular follow-up according to the guidelines of Kidney Disease- Improving Global Outcomes and of Chinese Medical Association in 2021.	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.
Unintegrated group; Patients in the unintegrated group are those who do not follow the contents of guidelines in some items of the integrated diagnosis and treatment during follow-up.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of all-cause mortality	Deaths from all causes during follow-up	Six months or more

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2022
• Primary Completion (ANTICIPATED): December 31, 2026
• Study Completion (ANTICIPATED): December 31, 2026

Study Registration Dates

• First Submitted: January 29, 2022
• First Submitted That Met QC Criteria: February 12, 2022
• First Posted (ACTUAL): February 16, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Urologic Diseases; Endocrine System Diseases; Renal Insufficiency; Nutrition Disorders; Musculoskeletal Diseases; Parathyroid Diseases; Avitaminosis; Deficiency Diseases; Lipid Metabolism Disorders; Dyslipidemias; Bone Diseases, Metabolic; Calcium Metabolism Disorders; Rickets; Vitamin D Deficiency; Hyperparathyroidism, Secondary; Hyperparathyroidism; Hyperglycemia; Kidney Diseases; Renal Insufficiency, Chronic; Malnutrition; Bone Diseases; Hyperlipidemias; Chronic Kidney Disease-Mineral and Bone Disorder
• Other Study ID Numbers: 202112-11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No