Safety of Short-term NSAID Use in the Postoperative Setting in Pediatric Patients With Chronic Kidney Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Frequency of Acute Kidney Injury
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
The IV formulation will be Normal Saline. The PO formulation will be compounded to have a similar look, volume, consistency and taste to the experimental medication. Participants will receive the IV formulation for no more than 8 doses. Participants will then receive the PO formulation. The total duration of intervention (IV + PO) will not exceed 5 days.
干预措施: Placebo (Drug)
NSAID
Participants will receive an intravenous (IV) ketorolac 0.5mg/kg/dose, 15mg maximum, for no more than 8 doses in keeping with the investigators' routine clinical practice. Participants will then receive the oral (PO) ibuprofen suspension 10mg/kg/dose, 400mg maximum. The total duration of intervention (IV + PO) will not exceed 5 days.
干预措施: NSAIDs (Drug)
结局指标
主要结局
Frequency of Acute Kidney Injury
时间窗: From start of intervention, through 14 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 ≥0.3 mg/dl increase within 48hrs, 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.
次要结局
- Opiates received while inpatient(From start of intervention, through 7 days later)
- Days with elevated pain score(From start of intervention, through hospitalization up to 5 days)