Down syndrome's estimated glomerular filtration rate trial

JRCT ID: jRCT1030220054

Registered date:10/05/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Down syndrome
• Date of first enrollment: 01/05/2022
• Target sample size: 15
• Study type: Observational

Outcome(s)

• Primary Outcome: Relationship between glomerular filtration rate obtained from inulin clearance and the ratio of reference serum creatinine levels in Down syndrome to serum creatinine levels in affected children.
• Secondary Outcome: Development of a polynomial approximation for the relationship between glomerular filtration rateobtained from inulin clearance and the commonly used estimated glomerular filtration rate equation.

Key inclusion & exclusion criteria

• Age minimum: >= 2age old
• Age maximum: <= 18age old
• Gender: Both

Include criteria

Children with Down syndrome between the ages of 2 and 18 years who had their inulin clearance measured at our facility.
Children who gave consent for this study.

Exclude criteria

1) Abnormally low (less than 0.5) or abnormally high (greater than 0.5) ratio of urinary inulin excretion to blood inulin concentration
2) GFR greater than 150 ml/min/1.73m2
3) Patients who have had surgery for congenital heart disease or are expected to have surgery in the future
4) Patients with severe renal dysfunction (anuria, oliguria, on dialysis)
5) Respiratory failure or heart failure requiring oxygen administration
6) Patients undergoing treatment for gastrointestinal symptoms or common cold symptoms
7) Women who are pregnant, may become pregnant, or who are breast-feeding
8) Patients with neurological disorders taking antiepileptic drugs
9) Complications of chromosomal or genetic abnormalities other than Down syndrome
10) If the doctor in charge judges that the patient is inappropriate to participate in this trial

Related Information

• Primary Sponsor: Nishino Tomohiko
• Secondary ID(s): UMIN000047572