A Novel Equation for Estimating Sodium Intake in Peritoneal Dialysis.

NCT05955417 | Unknown DMC

• 1 other identifier: 2022SF38
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dietary Sodium Intake

Keywords

Dietary Sodium Intake; Peritoneal Dialysis; Equation

Outcome Measures

Primary Outcomes (4)

• determination coefficient of the novel equation

  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

  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

  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

  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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Peritoneal Dialysis Patients

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Officials

• Jie Dong, Professor

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Dong, Professor

CONTACT

13911841538; jie.dong@bjmu.edu.cn

Lulu Jing

CONTACT

15201304983; jingll_wit@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of PD center

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 21, 2023
• Study Start: July 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share