Limiting AKI Progression In Sepsis (LAPIS): A Phase 4, Multicenter, Randomized Controlled Trial of Biomarker-guided Delivery of Kidney-sparing Care Measures in Sepsis Subjects at Risk of Developing AKI
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- BioMérieux
- 入组人数
- 19
- 试验地点
- 12
- 主要终点
- Number of deaths, dialysis or progression of AKI
研究概览
简要总结
Biomarkers that provide an early indicator of kidney stress could be useful in clinical practice to detect silent episodes of acute kidney injury (AKI) or for early identification of subjects at risk of AKI. Two urinary biomarkers have been identified as early indicators of AKI. The NephroCheck® test is a commercially available test that uses these biomarkers, and this study assesses the use of these in reducing negative clinical outcomes for patients with sepsis-associated AKI. The study will enroll subjects diagnosed with sepsis, including septic shock, who will be randomly assigned to either receive NephroCheck®-guided kidney-sparing and fast-tracking interventions; or to receive current Standard of Care assessment and treatment.
NOTE: Participants are no longer being recruited to this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of sepsis or septic shock.
- •Admission to the ICU or planned admission to the ICU with an expected stay of 72 hours or more after enrollment in the same hospital.
- •Expected to have indwelling urinary catheter placed and kept until at least 48 hours after enrollment.
- •Written informed consent.
排除标准
- •Women with known pregnancy, prisoners or institutionalized individuals.
- •Previous renal transplant.
- •Stage 2 or 3 Acute Kidney Injury (AKI) at screening.
- •Receiving dialysis (either acute or chronic), or in imminent need of dialysis at enrollment.
- •Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m
- •Known End Stage Renal Disease (ESRD) or history of active nephrotic syndrome within the last 3 months.
- •Known Stage 2-3 AKI within last 2 weeks.
- •Terminally ill (defined as expectation of death within 6 months), has a do not resuscitate order that would restrict protocol-required procedures, or is being admitted only for palliative care.
- •History of solid organ transplant and receiving calcineurin inhibitors.
- •Documented serious allergy (i.e. anaphylaxis) to vancomycin, aminoglycosides, penicillins, or cephalosporins (intravenous or oral).
- •Known current serum total bilirubin > 4mg/dL.
- •Subjects already included in an observational study can be co-enrolled in LAPIS. Subjects already included in an interventional study may be enrolled with pre-approval of the sponsor according to the following rules:
- •Co-enrollment in LAPIS will not be allowed with investigational drug and device studies;
- •Studies may be allowed if AKI or kidney function is not an endpoint with pre-approval of the LAPIS sponsor;
- •Co-enrollment in LAPIS will not be allowed if co-enrollment is an exclusion criterion in the other study.
- •Subjects with laboratory confirmed COVID-19 infection as the primary reason for hospital admission.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
NephroCheck-guided interventions
干预措施: Subject management guided by NephroCheck® test (Device)
Standard of Care
Standard of Care assessment and treatment
干预措施: Standard of Care (Other)
结局指标
主要结局
Number of deaths, dialysis or progression of AKI
时间窗: Enrollment to 72 hours
Measured by composite number of deaths, dialysis or progression of AKI. Dialysis defined as any form of renal replacement therapy (RRT); progression of AKI defined as Stage 0 to 2/3 or Stage 1 to 3.
次要结局
- Number of participants with progression of AKI(Enrollment to 48 and 72 hours)
- Number of participants receiving dialysis(Enrollment to 48 and 72 hours)
- Number of deaths(Enrollment to 48 and 72 hours)
- Number participants at Stage 2 or 3 AKI(Enrollment to 72 hours)
- ICU length of stay(Enrollment to hospital discharge or Day 60, whichever is sooner)