Integrated Diagnosis and Treatment of CKD on Outcomes

NCT05242055 | Recruiting DMC

• 1 other identifier: 202112-11
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Diseases; Hypertension; Hyperglycemia; Hyperlipidemias; Anemia; Chronic Kidney Disease-Mineral and Bone Disorder; Malnutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of all-cause mortality

  Six months or more

Study Arms (2)

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

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

Interventions

Integrated diagnosis and treatment for CKD OTHER

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.

Integrated group; Unintegrated group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• ≥18 years old;
• Voluntarily signed informed consent;
• Patients who are estimated to develop CKD.

You may not qualify if:

• Age \< 18 or ≥100 years;
• Unable to comply with the procedures stipulated in this study;
• Estimated follow-up time ≤6 months.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Nephrology Department of Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100035, China

RECRUITING

MeSH Terms

Conditions

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

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nephrology Department of Beijing Jishuitan Hospital

Study Record Dates

• First Submitted: January 29, 2022
• First Posted: February 16, 2022
• Study Start: February 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 6, 2022

Record last verified: 2022-05

Locations

CN (1)