A Novel Equation for Estimating Sodium Intake in Peritoneal Dialysis.

Not yet recruiting

• Conditions: Dietary Sodium Intake

• Registration Number: NCT05955417
• Lead Sponsor: Peking University First Hospital

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 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 Timeline

• Status Verified: 2023-07
• Study Start: 2023-07
• Study First Submitted: 2023-07-13
• Study First Submitted QC: 2023-07-13
• Study First Posted: 2023-07-21
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-27
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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) .