24-hour Urinary Electrolyte Excretion in Chronic Kidney D... | NCT05550467

Studies
24-hour Urinary Electrolyte Excretion in Chronic Kidney Disease

NCT05550467

Sponsor

Chinese PLA General Hospital

Status

Completed

Last Update Posted

Sep 22, 2022Actual

Enrollment

10,000Actual

Phase

Not provided

Conditions

Chronic Kidney Diseases
Electrolyte Imbalance

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2014Actual

Primary Completion Date

Jul 30, 2022Actual

Completion Date

Jul 31, 2022Actual

First Submitted Date

Sep 19, 2022

First Submission Date that Met QC Criteria

Sep 19, 2022

First Posted Date

Sep 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2022

Last Update Posted Date

Sep 22, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Association between excretion pattern and development trajectory of urinary electrolytes (urine sodium, urine potassium, urine chlorine, urine magnesium, urine calcium, urine phosphorus, urine creatinine, urea, uric acid, urine glucose, urine protein, urine retinol) and adverse prognosis in patients with chronic kidney disease

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Kidney disease progression	eGFR decline > 50%; dialysis; kidney transplant	2014.1.1-2022.7.31
Death	All cause death	2014.1.1-2022.7.31

Secondary Outcomes

Measure	Description	Time Frame
Cardiovascular disease	myocardial infarction, angina pectoris, stable heart failure, peripheral artery disease , revascularization, cerebrovascular events	2014.1.1-2022.7.31

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Our study is a retrospective cohort study. The study included patients with adult（Age≥18years）CKD who were hospitalized in the Department of Nephrology, First Medical Center of Chinese PLA General Hospital from January 2014 to July 2022. Patients with CKD who had one or more 24-hour urinary electrolyte excretion tests at intervals of more than three months were included in the subgroup analysis.

Exclusion Criteria:

Patients with hemodialysis therapy and urine volume less than 500ml were excluded.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Age ≥ 18 years, chronic kidney disease patients without kidney replacement therapy who had 24-h urine eletrocyte tests.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided