End Stage Renal Disease on DialysisNCT05549050
Correlation Between Interdialytic Weight Gain and Cardiovascular Diseases in Children With End-Stage Kidney Disease Undergoing Hemodialysis
An observational study of End Stage Renal Disease on Dialysis, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study aimed to discuss the correlation between interdialytic weight gain and cardiovascular diseases in children with end-stage kidney disease undergoing chronic hemodialysis. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- End Stage Renal Disease on Dialysis
- What is being tested?
- interdialytic weight gain
- How many people
- 75 participants
- Where
- 1 siteIndonesia
- Study dates
- 8 Jul 2022to Jul 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: End-stage kidney disease children aged 2-18 years old
Who may be able to join
- End-stage kidney disease (chronic kidney disease stage 5)
- Undergo hemodialysis at least twice a week
Who cannot join
- History of congenital heart disease
- Critically ill patients with unstable hemodynamic status
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Cipto Mangunkusumo Hospital
Jakarta Pusat, Jakarta Special Capital Region, 10430
Henny A Puspitasari, dr. Sp.A(K), +6281218603930, henny.adriani.01@ui.ac.id
About this study
This study aimed to discuss the correlation between interdialytic weight gain and cardiovascular diseases in children with end-stage kidney disease undergoing chronic hemodialysis. The cardiovascular parameters used include left ventricular hypertrophy, systolic and diastolic function, carotid intima-media thickness, myocardial circumferential strain, and strain rate.
- Conditions
- End Stage Renal Disease on Dialysis
- Being tested
- interdialytic weight gain
- Keywords
- interdialytic weight gain, cardiovascular, chronic kidney disease, hemodialysis
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interdialytic weight gainOther
interdialytic weight gain during hemodialysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between interdialytic weight gain and cardiovascular diseases in children with end-stage kidney disease undergoing hemodialysis
Correlation between interdialytic weight gain and cardiovascular diseases in children with end-stage kidney disease undergoing hemodialysis
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start8 Jul 2022
- Primary completionMar 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease on DialysisStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henny Adriani Puspitasari, Universitas Indonesia
- Investigators
- Henny A Puspitasari, dr. Sp.A(K), Principal investigator, Department of Child Health, Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549050
- Sponsor's protocol ID
- 21-10-1072
- Status last verified
- Sep 2022
- First submitted
- 17 Sep 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Interdialytic Weight Gain and Cardiovascular Diseases in Children With End-Stage Kidney Disease Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT05549050
- Acronym / sponsor ID
- 21-10-1072
- Conditions
- End Stage Renal Disease on Dialysis
- Keywords
- interdialytic weight gain, cardiovascular, chronic kidney disease, hemodialysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 22 Sep 2022 (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.
This study aimed to discuss the correlation between interdialytic weight gain and cardiovascular diseases in children with end-stage kidney disease undergoing chronic hemodialysis. The cardiovascular parameters used include left ventricular hypertrophy, systolic and diastolic function, carotid intima-media thickness, myocardial circumferential strain, and strain rate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- End-stage kidney disease children aged 2-18 years old
Key inclusion criteria (2 listed)
- End-stage kidney disease (chronic kidney disease stage 5)
- Undergo hemodialysis at least twice a week
Key exclusion criteria (2 listed)
- History of congenital heart disease
- Critically ill patients with unstable hemodynamic status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interdialytic weight gaininterdialytic weight gain during hemodialysis | Other | – |
Primary outcome
Correlation between interdialytic weight gain and cardiovascular diseases in children with end-stage kidney disease undergoing hemodialysis
Time frame: Through study completion, an average of 1 year
Correlation between interdialytic weight gain and cardiovascular diseases in children with end-stage kidney disease undergoing hemodialysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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.
Henny A Puspitasari, dr. Sp.A(K) principal investigator
Department of Child Health, Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital
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 End Stage Renal Disease on Dialysis, run by Universitas Indonesia at 1 site in Indonesia.
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 2 inclusion and 2 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 30 Sep 2022. 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 Indonesia. 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 Henny A Puspitasari, dr. Sp.A(K) (+6281218603930, henny.adriani01@ui.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between interdialytic weight gain and cardiovascular diseases in children with end-stage kidney disease undergoing hemodialysis (time frame: Through study completion, an average of 1 year). 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 30 Sep 2022.