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Completed

NCT Number: NCT05955417

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.

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Key information

Conditions

Dietary Sodium Intake Peritoneal Dialysis (PD)

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University First Hospital

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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) .

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 21, 2023
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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