- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05549050
Correlation Between Interdialytic Weight Gain and Cardiovascular Diseases in Children With End-Stage Kidney Disease Undergoing Hemodialysis
September 29, 2022 updated by: Henny Adriani Puspitasari, Indonesia University
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
75
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Henny A Puspitasari, dr. Sp.A(K)
- Phone Number: +6281218603930
- Email: henny.adriani01@ui.ac.id
Study Contact Backup
- Name: Callen Zulkifli, dr.
- Phone Number: +6285966795947
- Email: callen@alumni.ui.ac.id
Study Locations
-
-
Jakarta
-
Jakarta Pusat, Jakarta, Indonesia, 10430
- Recruiting
- Cipto Mangunkusumo Hospital
-
Contact:
- Henny A Puspitasari, dr. Sp.A(K)
- Phone Number: +6281218603930
- Email: henny.adriani.01@ui.ac.id
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
End-stage kidney disease children aged 2-18 years old
Description
Inclusion Criteria:
- End-stage kidney disease (chronic kidney disease stage 5)
- Undergo hemodialysis at least twice a week
Exclusion Criteria:
- History of congenital heart disease
- Critically ill patients with unstable hemodynamic status
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Henny A Puspitasari, dr. Sp.A(K), Department of Child Health, Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 8, 2022
Primary Completion (Anticipated)
March 1, 2023
Study Completion (Anticipated)
July 1, 2023
Study Registration Dates
First Submitted
September 17, 2022
First Submitted That Met QC Criteria
September 17, 2022
First Posted (Actual)
September 22, 2022
Study Record Updates
Last Update Posted (Actual)
September 30, 2022
Last Update Submitted That Met QC Criteria
September 29, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-10-1072
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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