Dietary Sodium Intake in Children on Chronic Dialysis (PeDialysis)

Dietary Sodium Intake in Children on Chronic Dialysis: A Collaborative Study With the European Pediatric Dialysis Working Group

Cardiovascular disease is common in patients with end-stage renal disease that began in childhood, and volume overload plays a key role in the development of hypertension, left ventricular hypertrophy (LVH) and alterations. cardiovascular disease in this population. Thus, inter-dialytic weight gain is correlated with blood pressure and left ventricular mass index in children on hemodialysis (HD). Significant inter-dialytic weight gain in dialysis patients is largely due to thirst secondary to salt ingestions: attempts at water restriction without concomitant sodium restriction will probably be in vain. Additionally, sodium overload negatively affects blood pressure and cardiovascular status through various mechanisms unrelated to volume expansion.

Soda extraction by dialysis is often difficult, and sodium control is largely dependent on restricting dietary sodium intake. Some studies in adults have shown that a low sodium diet reduced inter-dialytic weight gain, reduced intra-dialytic complications, improved blood pressure values, and lowered index. left ventricular mass and mortality in dialysis patients.

For children with chronic kidney disease, data from the American Chronic Kidney Disease (CKiD) study show that the median sodium intake in children without dialysis with chronic kidney disease exceeds the maximum recommended intakes for all patients. age groups.

No study to date has investigated the average dietary sodium intake of children on dialysis. And, more importantly, the relationship between dietary sodium intake and cardiovascular morbidity has never been studied in children on dialysis.

Study Overview

• Status: Recruiting
• Conditions: Chronic Dialysis in Children

• Study Type: Observational
• Enrollment (Estimated): 4

Contacts and Locations

• Study Contact: Name: Ariane ZALOSZYC, MD; Phone Number: 33 3 88 12 77 42; Email: ariane.zaloszyc@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Service de Pédiatrie 1 - CHU de Strasbourg - France
    • Contact: Ariane ZALOSZYC, MD; Phone Number: 33 3 88 12 77 42; Email: ariane.zaloszyc@chru-strasbourg.fr
    • Principal Investigator: Ariane ZALOSZYC, MD
    • Sub-Investigator: Fabio PAGLIALONGLA, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Minor patient (≥ 3 months and <18 years) having benefited from chronic dialysis (> 3 months) and having undergone hemodialysis (HD) or hemodiafiltration (HDF), 3 sessions / week, or automated peritoneal dialysis (PD) at the University Hospitals of Strasbourg

Description

Inclusion Criteria :

• Minor patient (≥ 3 months and <18 years)
• Under the care of the University Hospitals of Strasbourg
• Having benefited from chronic dialysis (> 3 months)
• Having undergone hemodialysis (HD) or hemodiafiltration (HDF), 3 sessions / week, or automated peritoneal dialysis (PD)
• Subject (and / or his parental authority) not having expressed, after being informed, his opposition to the reuse of his data for the purposes of this research.

Non-Inclusion Criteria :

• Patient or one of the parents who expressed their opposition to participating in the study
• Intensive hemodialysis (HD at home, HD at night, ≥ 4 sessions / week)
• Intercurrent illness or clinical instability (left to the judgment of the physician)
• Non-nephrological diseases causing loss of salt (eg cystic fibrosis, etc.)
• Any physical or psychosocial situation that prevented the 24-hour ambulatory BP measurement from being taken, or poor compliance with the dietetic collection, etc.).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the average dietary intake of sodium (Na+) in a population of children on chronic dialysis.	The average dietary intake of sodium (Na+) is calculated according to the formula: sodium salt content (g) = Sodium (g) × 2.54	Files analysed retrospectively from January 1, 2019 to February 28, 2021 will be examined

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Estimated): December 11, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Left Ventricular Hypertrophy; Renal Diseases; Hemodialysis Complication; Chronic Dialysis in Children
• Other Study ID Numbers: 8171

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No