'Preventable Acute Kidney Injury (AKI) Should Never Occur.' The Use of a Novel Electronic Prediction Alerting Tool to Deliver an Individualised Care Package for Hospital In-patients at Risk of AKI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30,298
- 试验地点
- 1
- 主要终点
- Hospital Acquired AKI (HA-AKI) - KDIGO rise in serum creatinine
研究概览
简要总结
Around a third of patients who develop acute kidney injury (AKI) do so after a hospital admission (hospital-acquired - HA-AKI).
The primary aim of the study is to prospectively test whether introducing a complex intervention (a 'care package' - comprising a clinical prediction rule incorporating an electronic alert which generates a checklist for patient management to relevant health professionals) can identify patients on admission to hospital who are at risk of developing HA-AKI, highlight the need for closer monitoring and allow putative preventative measures to be put in place.
The investigators will introduce the care package in one acute hospital and evaluate its effectiveness in reducing HA-AKI and its associated morbidity, over ten months, compared to a sister hospital within the same Trust (which will act as a control site). The investigators will extend evaluation for a further ten months to assess sustainability on the first site and introduce the package at the control hospital to assess generalisability. The primary aim is reducing HA-AKI, but secondary aims will include improved outcomes associated with HA-AKI, management of patients already with AKI on admission to hospital (whose care may also benefit from the checklist) and a cost-effectiveness analysis.
详细描述
Acute Kidney Injury (AKI) is common in hospital (incidence of 10-20% - up to 70% in the critically ill), with high associated morbidity and mortality. Even small changes in renal function are associated with increased mortality. The 2009 National Confidential Enquiry into Patient Outcome and Death examined the care of patients who had died in hospital with a primary diagnosis of AKI. Over 40% of cases had an unacceptable delay in diagnosis and in 20% of cases, AKI was thought to be predictable and avoidable.
Electronic alerts have been studied for patients with established AKI, however, they have highlighted rises in creatinine after insult rather than identifying patients at risk of AKI - a third of hospital AKI cases occur after admission (HA-AKI). Risk factors have been reported in surgical and burns patients. However, strategies to identify patients admitted as medical emergencies at risk of developing AKI are lacking - the group accounting for most Intensive Care admissions with AKI.
The investigators multidisciplinary team, with significant experience utilising technology in healthcare, have developed a novel prediction score - Acute Kidney injury Prediction Score (APS). Utilising physiological measurements, biochemical parameters and known co-morbidities, the APS identifies patients at risk of developing HA-AKI following admission (1/3 of all AKI cases).
A 'care package' has been devised incorporating the APS into an automated electronic algorithm to send realtime alerts to staff on the Observation chart, e-mail the patient's Consultant and advise on a checklist. Alongside this, an E-learning AKI module for ward staff has been developed building on NICE Guidance with additional information regarding the APS.
Aims Primary: investigate whether introducing a 'care package' can reduce HA-AKI in patients admitted to hospital as an emergency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Admission as an emergency
- •Spending at least one night as an in-patient
排除标准
- •Patients under 18
- •Patients not admitted as emergencies or staying less than one night in hospital.
结局指标
主要结局
Hospital Acquired AKI (HA-AKI) - KDIGO rise in serum creatinine
时间窗: <7 days from time of hospital admission
HA-AKI will be defined as per KDIGO change in serum creatinine i.e. a ≥26.4μmol/L increase within a 48 hour period (during the first 7 days of admission to hospital) or a 1.5 times increase vs the admission result within the first 7 days of admission to hospital.
次要结局
- Admission to Intensive Care Unit (ICU)(At any time point during the admission under analysis i.e. from admission to either discharge from the hospital or death in-hospital, participants will be followed for the duration of hospital stay, expected average of 7 days.)
- Mortality(During the index hospital admission. Each participant will be followed for the duration of hospital stay, an expected average of 7 days.)
- Mortality associated with AKI on admission(During the index hospital admission. Each participant will be followed for the duration of hospital stay, an expected average of 7 days.)
- Magnitude of acute deterioration in Creatinine(From admission to peak creatinine within the first 7 days of the index admission.)
- Requirement for renal replacement therapies(During the hospital admission. During the index hospital admission. Each participant will be followed for the duration of hospital stay, an expected average of 7 days.)