Safety of Short-course of NSAIDs in Pediatric Patients With CKD

Phase

Condition

Pediatric Health

Kidney Disease

Kidney Failure

Treatment

Placebo

NSAIDs

Clinical Study ID

NCT06860711

24-1252

Ages > 18
All Genders

Study Summary

The purpose of this study is to determine if non-steroidal anti-inflammatory (NSAID) use in the postoperative setting increases the risk of acute kidney injury (AKI) in pediatric patients with mild-to-moderate chronic kidney disease (CKD). The investigators hypothesize that there is no increased risk. This will be a limited pilot study within a Pediatric Urology population, intended to inform future work in a larger patient population.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients over 18 months of age
diagnosis of CKD stages 2-3a, confirmed by cystatin C laboratory testing within 6months of surgery

Exclusion

Exclusion Criteria:

diagnosis of CKD stage 1 or 4-5
home medications of angiotensin converting enzyme inhibitors (ACEi, such aslisinopril or captopril) or angiotensin receptor blocker (ARB, such as losartan,valsartan) diuretics, or trimethoprim
IV contrast in last 30 days
PMH of renal transplant, diabetes, hypertension, nephrotic syndrome or heartfailure, asthma, or hyperthyroidism
history of hyperkalemia
recent glucocorticoid exposure
procedure for oncologic indications
ongoing viral or fungal infection, or chemotherapy
allergy to NSAIDs

Study Design