A Novel Equation for Estimating Sodium Intake in Peritoneal Dialysis.

July 24, 2023 updated by: Dong Jie, Peking University First Hospital

The Development and Validation of a Novel Equation for Estimating Sodium Intake in Peritoneal Dialysis

This study aims to develop a novel equation for estimating sodium intake in anuric peritoneal dialysis patients, and then to validate its precision and accuracy.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Dietary sodium intake is closely associated with the prognosis of chronic kidney disease (CKD) patients. Previous studies have developed an equation for estimating dietary sodium intake through 24-hour urine sodium in CKD, which are not applicable in peritoneal dialysis patients. This study aims to develop a novel equation for estimating dietary sodium intake in 20 anuric peritoneal dialysis patients, using accurately measured dietary sodium as the dependent variable and peritoneal sodium clearance and its related variables as independent variables, and then to validate the precision and accuracy of the novel equation in another 20 anuric peritoneal dialysis patients.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

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

Study Contact

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Peritoneal Dialysis Patients

Description

Inclusion Criteria:

  • Peritoneal dialysis vintage >3 months.
  • 18-80 years old.
  • No residual renal function (urine volume<200ml/day).
  • Continuous ambulatory peritoneal dialysis or manual intermittent peritoneal dialysis.

Exclusion Criteria:

  • Peritonitis in the past month.
  • Acute systemic infection, cardio-cerebrovascular complications and surgical trauma in the past month.
  • Uncorrected hyponatremia (blood sodium<130mmol/L).
  • Prescribed with sodium bicarbonate and other drugs containing sodium.
  • Prescribed with glucocorticoids and aldosterone antagonists.
  • Dysfunction of peritoneal dialysis catheter.
  • Malignant tumor receiving radiotherapy and chemotherapy, severe dyspepsia or eating disorder.
  • Body fluid loss due to vomit, diarrhea, massive sweating, or other causes.
  • Cannot follow the research scheme.
  • Refuse to participate in this study.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
determination coefficient of the novel equation
Time Frame: July 3, 2023, to March 1, 2024
Determination coefficient will be assessed as the square of the multiple correlation coefficient of the novel equation for estimating sodium intake in peritoneal dialysis.
July 3, 2023, to March 1, 2024
bias of the novel equation
Time Frame: July 3, 2023, to March 1, 2024
Bias will be assessed as the median of the difference between the estimated and measured dietary sodium values.
July 3, 2023, to March 1, 2024
precision of the novel equation
Time Frame: July 3, 2023, to March 1, 2024
Precision will be assessed as the standard deviation (SD) for the absolute value of difference between the estimated and measured dietary sodium values.
July 3, 2023, to March 1, 2024
accuracy of the novel equation
Time Frame: July 3, 2023, to March 1, 2024
Accuracy will be assessed as the percentage of estimates that differed >20% from the measured dietary sodium values (1-P20) .
July 3, 2023, to March 1, 2024

Collaborators and Investigators

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

Sponsor

Peking University First Hospital

Investigators

  • Principal Investigator: Jie Dong, Professor, Peking University First Hospital

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 (Estimated)

July 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

July 13, 2023

First Submitted That Met QC Criteria

July 13, 2023

First Posted (Actual)

July 21, 2023

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022SF38

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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