Chronic Kidney Disease, Pediatric Urology
Conditions
Keywords
NSAIDs, CKD, Pediatrics, Urology, post-surgical
Brief 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.
Interventions
DRUGNSAIDs
IV formulation: ketorolac 0.5mg/kg/dose, 15mg maximum, no more than 8 doses total PO formulation: ibuprofen suspension 10mg/kg/dose, 400mg maximum Total duration (IV + PO) will not exceed 5 days.
DRUGPlacebo
IV or PO medication, compounded to have similar look, consistency and taste to the corresponding medications
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 18 months of age * diagnosis of CKD stages 2-3a, confirmed by cystatin C laboratory testing within 6 months of surgery
Exclusion criteria
* diagnosis of CKD stage 1 or 4-5 * home medications of angiotensin converting enzyme inhibitors (ACEi, such as lisinopril 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 heart failure, asthma, or hyperthyroidism * history of hyperkalemia * recent glucocorticoid exposure * procedure for oncologic indications * ongoing viral or fungal infection, or chemotherapy * allergy to NSAIDs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Acute Kidney Injury | From start of intervention, through 7 days later | Acute kidney injury (AKI) will be assessed for according to Kidney Disease Improving Global Outcomes (KDIGO) criteria. Specifically, an AKI will be defined as a serum creatinine increase of ≥ 1.5 times baseline or ≥3 mg/dl increase, or a urine output \<0.5ml/kg/h for 6 to 12 hours. While there are 3 stages of AKI, the investigators will consider AKI a binary outcome since all stages are managed the same clinically. Urine output is recorded as a routine part of strict intake & output monitoring by nursing. The serum creatinine will be compared to the pre-incisional/baseline data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opiates received while inpatient | From start of intervention, through 7 days later | Opiate use will be calculated as morphine equivalents per day, adjusted for weight. |
| Days with elevated pain score | From start of intervention, through 7 days later | Pain scores will be assessed using the Faces Pain Scale - Revised (FPS-R) or the visual analogue scale (VAS) depending on age, per nursing routine. The former is used for patients aged 4-8 years, and latter for patients aged 9 and older. These have previously been shown to be interchangeable. Both pain scales have a range from 0-10, with 10 being the worst. This metric will not be captured for patients under 4 years of age. The percentage of days with severe, or a pain score greater than 7 will be reported. |
Countries
United States
Contacts
Primary ContactKyle Rove, MD
Backup ContactJennifer Pyrzanowski, MSPH
Outcome results
None listed