Assessing the Feasibility of N-of-1 Trials in Children With Hypertension and Chronic Kidney Disease

The University of Texas System (UT)

Status: Completed

Conditions: Chronic Kidney Diseases; Hypertension

Treatments: Procedure: n-of-1 trial guided clinical decision making

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04591171

HSC-MS-20-1005

Details and patient eligibility

About

The purpose of this study to test whether n-of-1 trial-guided clinical decision-making improves blood pressure control in hypertensive children with chronic kidney disease (CKD) and end-stage renal disease (ESRD).

Enrollment: 9 patients

Sex: All

Ages: 5 to 22 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• hypertension
• CKD stage 2-5
• requiring antihypertensive medication per clinician judgement.

Exclusion criteria

• renal transplant anticipated or occurred within 6 months of screening
• transfer out of our practice setting anticipated within 6 months
• unable to complete 24 hour arterial blood pressure monitoring (ABPM) due to developmental or behavioral limitations

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

n-of-1 trial guided clinical decision making

Experimental group

Treatment:

Procedure: n-of-1 trial guided clinical decision making