A Novel Equation for Estimating Sodium Intake in Peritoneal Dialysis.

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05955417

Enrollment

Registered

2023-07-21

Start date

2023-08-01

Completion date

2025-01-20

Last updated

2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Sodium Intake, Peritoneal Dialysis (PD)

Keywords

Dietary Sodium Intake, Peritoneal Dialysis, Equation

Brief summary

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.

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 removal and its related variables as independent variables, and then to validate the precision and accuracy of the novel equation in another 10 anuric peritoneal dialysis patients.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Peritoneal dialysis vintage \>3 months. * 18-80 years old. * No residual renal function (urine volume\<200ml/day).

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. * 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.

Design outcomes

Primary

Measure	Time frame	Description
determination coefficient of the novel equation	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.
bias of the novel equation	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.
precision of the novel equation	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.
accuracy of the novel equation	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) .

Countries

China

Contacts

PRINCIPAL_INVESTIGATORJie Dong, Professor

Peking University First Hospital

Outcome results