Effect of Implementing a Care Bundle on the Progression of Acute Kidney Injury in Critical Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 主要终点
- AKI progression
研究概览
简要总结
The goal of this clinical interventional study is to learn about the effect of implementing a care bundle in the progression of acute kidney injury (AKI) in critical patients. The main questions it aims to answer are:
- What is the impact of care bundle in AKI progression?
- Some improvement of care bundle adhesion rate through an electronic alert can be achieved?
Participants will be adults and critical patients with AKI. During observational study the incidence and progression of AKI will be measured, as well spontaneous care bundle adhesion by medical team. In the interventional study, the progression rate of AKI influenced by care bundle will be measured, as well the adhesion of care bundle through an electronic alert inserted in the patient's daily medical record.
详细描述
This is a clinical, multicentric and prospective trial (study type: "before" and "after"). Patients aged ≥18 years, admitted to clinical and surgical intensive care units (ICUs) will be included according to selection criteria.
During observational and interventional studies clinical and laboratorial information from electronic medical records will be registered. AKI diagnosis and classification will be based on serum creatinine levels according to kidney disease improving global outcomes (KDIGO) criteria.
The observational study will be carried out to measure the incidence of AKI KDIGO 1 and its progression rate, in order to estimate sample size for the interventional study. Researchers assumed a 10% to 20% reduction in the progression of AKI KDIGO 1 to more advanced stages after the implementation of the care bundle. In the interventional study, the care bundle will be included in the medical records of each individual who develops AKI KDIGO 1. Patients included in this study will be followed by 7 days from inclusion. Adhesion rate to the care bundle will be measured between observational and interventional studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with recent ICU admission (≤ 48 hours)
- •Patients without AKI or with AKI KDIGO 1 at the time of admission
排除标准
- •Patients with chronic kidney disease, stage 4 to 5D
- •Patients with kidney transplant
- •Patients with AKI KDIGO 2, 3 or on dialysis at the time of inclusion in the study
结局指标
主要结局
AKI progression
时间窗: ≤ 7 days from inclusion
AKI progression from KDIGO 1 to KDIGO 2 or 3
次要结局
- Adherence to care bundle(≤ 7 days from inclusion)
研究者
Lygia Lussim
Principal Investigator
University of Campinas, Brazil