Safety of Short-course of NSAIDs in Pediatric Patients With CKD
Recruiting · NCT06860711 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Colorado, Denver
View the official record on ClinicalTrials.gov →Interventions studied
NSAIDsPlacebo
What this trial is about
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 is currently in the process of developing multi institution collaboration within a Pediatric Urology population, intended to inform future work in a larger patient population.
Who can take part
Age range
18 Months to 25 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Patients over 18 months of age
- diagnosis of CKD stages 2-3a, confirmed by CKiD U25 eGFR calculator based on cystatin C laboratory testing within 6 months of surgery
- Patient is scheduled to undergo a urologic surgery requiring admission or overnight stay in the hospital
Exclusion criteria
- Diagnosis of CKD stage 1 or 4-5
- Past medical history of renal transplant
- Past medical history of nasal polyp
- Procedure for oncologic indications or on chemotherapy
- Pregnant patient
- True allergy to NSAIDs
Where it is running
1 location listed across 1 US state.
- Children's Hospital Colorado - Aurora, Colorado, United States