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A Novel Equation for Estimating Sodium Intake in Peritoneal Dialysis.

Sponsor
Peking University First Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05955417
Collaborator
(none)
40
Enrollment
8
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Development and Validation of a Novel Equation for Estimating Sodium Intake in Peritoneal Dialysis
    Anticipated Study Start Date :
    Jul 1, 2023
    Anticipated Primary Completion Date :
    Mar 1, 2024
    Anticipated Study Completion Date :
    Mar 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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) .

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Peking University First Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dong Jie, Director of PD center, Peking University First Hospital
    ClinicalTrials.gov Identifier:
    NCT05955417
    Other Study ID Numbers:
    • 2022SF38
    First Posted:
    Jul 21, 2023
    Last Update Posted:
    Jul 27, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dong Jie, Director of PD center, Peking University First Hospital
    Dietary Sodium Intake
    Peritoneal Dialysis
    Equation

    Study Results

    No Results Posted as of Jul 27, 2023