Dietary Sodium Intake in Children on Chronic Dialysis

NCT ID: NCT06165640

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-25

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Dialysis in Children

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Chronic Dialysis in Children Cardiovascular Diseases Renal Diseases Left Ventricular Hypertrophy Hemodialysis Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.


* 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.).
Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Service de Pédiatrie 1 - CHU de Strasbourg - France

Strasbourg, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ariane ZALOSZYC, MD

Role: CONTACT

Phone: 33 3 88 12 77 42

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ariane ZALOSZYC, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

8171

Identifier Type: -

Identifier Source: org_study_id