Chronic Dialysis in ChildrenPeDialysisNCT06165640
Dietary Sodium Intake in Children on Chronic Dialysis
An observational study of Chronic Dialysis in Children, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Chronic Dialysis in Children
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 25 Feb 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- Child
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
Who may be able to join
- 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 :
Show all 11Show fewer
- 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.).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Pédiatrie 1 - CHU de Strasbourg - France
Strasbourg, 67091
Ariane ZALOSZYC, MD, 33 3 88 12 77 42, ariane.zaloszyc@chru-strasbourg.fr
Ariane ZALOSZYC, MD
About this study
Official title: 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.
Read more
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.
- Conditions
- Chronic Dialysis in Children
- Keywords
- Chronic Dialysis in Children, Cardiovascular Diseases, Renal Diseases, Left Ventricular Hypertrophy, Hemodialysis Complication
- Medical subject headings
- Cardiovascular Diseases, Kidney Diseases, Hypertrophy, Left Ventricular
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Files analysed retrospectively from January 1, 2019 to February 28, 2021 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start25 Feb 2021
- Primary completionDec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Dialysis in ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165640
- Sponsor's protocol ID
- 8171
- Acronym
- PeDialysis
- Status last verified
- Dec 2022
- First submitted
- 13 Dec 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Sodium Intake in Children on Chronic Dialysis: A Collaborative Study With the European Pediatric Dialysis Working Group
- ClinicalTrials.gov ID
- NCT06165640
- Acronym / sponsor ID
- PeDialysis / 8171
- Conditions
- Chronic Dialysis in Children
- Keywords
- Chronic Dialysis in Children, Cardiovascular Diseases, Renal Diseases, Left Ventricular Hypertrophy, Hemodialysis Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Age groups
- Child
- 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
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the average dietary intake of sodium (Na+) in a population of children on chronic dialysis.
Time frame: Files analysed retrospectively from January 1, 2019 to February 28, 2021 will be examined
The average dietary intake of sodium (Na+) is calculated according to the formula: sodium salt content (g) = Sodium (g) × 2.54
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Dialysis in Children, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ariane ZALOSZYC, MD (33 3 88 12 77 42, ariane.zaloszyc@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the average dietary intake of sodium (Na+) in a population of children on chronic dialysis. (time frame: Files analysed retrospectively from January 1, 2019 to February 28, 2021 will be examined). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.