The Association Between sUCR and the Survival in Patients With DKD

November 2, 2020 updated by: Guangdong Provincial People's Hospital

The Association Between Serum Urea Nitrogen to Creatinine Ratio and the Survival in Patients With DKD

Research Objective: To evaluate the prognostic value of serum urea nitrogen to creatinine ratio (sUCR) in the progression of DKD.

Research Design: This study was designed as a multicenter, retrospective cohort study. According to sex and CKD stage , patients are divided into four groups,then evaluate the prognostic value of mean sUCR and ΔsUCR (fluctuation of sUCR over time, meaning monthly rate of change) in the progression of DKD.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Object and source: Patients diagnosed with DKD who meet the inclusion criteria are enrolled into the study.

Observation index: At baseline and every medical visit, therapeutic relevant information was collected. Data mainly include demographic characteristics(age, gender, place of residence, marriage, education degree), lifestyles(smoking, drinking, exercise), clinical characteristics(body mass index, blood pressure, duration , history of CVD, complications, nutrition situation), laboratory indexes (serum creatinine, blood urea nitrogen, glycosylated hemoglobin, urinary albumin to creatinine ratio, 24-hour urinary albumin, 24-hour urine urea nitrogen, etc.).

Quality assurance plan: The present study should be performed according to the principles of the Declaration of Helsinki and has been approved by the Ethics Committee of Guangdong Provincial People's Hospital.

Plan for missing data: When the participants drop out, the researcher should contact the participants by phone, email, text message, letter etc. and ask the reason, making record as full as possible.

Statistical analysis plan: Data are presented as mean±SD for continuous variables and as a number(percentage) for categorical variables. According to sex and CKD stage , patients are divided into four groups,then evaluate the prognostic value of mean sUCR and ΔsUCR (fluctuation of sUCR over time, meaning monthly rate of change) in the progression of DKD. The relationship between baseline characteristics among the four groups was compared by using one-way analysis of variance test, Kruskal-Wallis test or Chi-squared test where appropriate. Survival rates are estimated using Kaplan-Meier analysis, and the significance of differences was analyzed using the log-rank test. Cox proportional hazard regression analysis is used to assess the association between the clinical outcomes and mean sUCR and ΔsUCR. In multivariate analysis, we enter variables using a P value of <0.10 as the selection criterion or considered clinically significant. Hazard ratios (HRs) are presented with 95% CIs. All statistical analysis was performed with the use of SPSS (version 19.0, SPSS, Chicago, USA) and Prism 7.0 (GraphPad Software, San Diego, CA, USA). A two-tailed P value <0.05 was considered to be statistically significant.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
          • Wenjian Wang, PhD
          • Phone Number: 0086-020-83827812-61421
          • Email: wwjph@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

DKD was defined as those diagnosed by pathological biopsy, or those with eGFR <60 ml/min per 1.73 m2, or presence of clinically detectable albuminuria over 3 months which is caused by diabetes.

Description

Inclusion criteria:

  • Patients were diagnosed with DKD, and CKD stages 1-4.

    • Patients' age was between 18-70 years old. ③Clinical datum were complete.

Exclusion criteria:

①Patients were combined with other type of kidney disease; ②Pregnancy women; ③Infection; ④Severe liver disease; ⑤ malignant tumor;⑥Acute heart failure; ⑦Acute cardiovascular and cerebrovascular diseases ⑧gastrointestinal hemorrhage.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Group A are males with CKD stage 1-2.
Other: serum urea nitrogen to creatinine ratio
According to sex and CKD stage , patients are divided into four groups,then evaluate whether the different mean sUCR and ΔsUCR can influent the survival of DKD patients.
Group B
Group B are males with CKD stage 3-4.
Other: serum urea nitrogen to creatinine ratio
According to sex and CKD stage , patients are divided into four groups,then evaluate whether the different mean sUCR and ΔsUCR can influent the survival of DKD patients.
Group C
Group C are females with CKD stage 1-2.
Other: serum urea nitrogen to creatinine ratio
According to sex and CKD stage , patients are divided into four groups,then evaluate whether the different mean sUCR and ΔsUCR can influent the survival of DKD patients.
Group D
Group D are females with CKD stage 3-4.
Other: serum urea nitrogen to creatinine ratio
According to sex and CKD stage , patients are divided into four groups,then evaluate whether the different mean sUCR and ΔsUCR can influent the survival of DKD patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause death
Time Frame: 10 years
according to the criteria of death
10 years
a composite of end-stage kidney disease
Time Frame: 10 years
dialysis, transplantation, or a sustained estimated GFR of <15 ml per minute per 1.73 m2
10 years
increasing by 50% of the serum creatinine level from baseline
Time Frame: 10 years
increasing by 50% of the serum creatinine level from baseline
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Investigators

  • Study Chair: Wenjian Wang, PhD, Guangdong Provincial People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

November 2, 2020

First Posted (Actual)

November 3, 2020

Study Record Updates

Last Update Posted (Actual)

November 3, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WJWang002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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