Effect of Organisation of Medical Care on Health Status in Patients With Acute Kidney Injury
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- MACE
研究概览
简要总结
Various forms of organisation in the care of patients with akute kidney injury are investigated.
In this prospective study the investigators compare the effect of usual care with the effect of intensive care. Primary endpoint is the development of cardiovascular events ("major adverse cardiovascular events" "MACE").
详细描述
The investigators plan to investigate the use of various organisation forms in the care of patients with the diagnosis of acute kidney injury in the hospital. This prospective study compares the effect of usual care with the effect of intensive care in the hospital and outpatient health care center. Primary endpoint is the development of cardiovascular events ("major adverse cardiovascular events" "MACE"). Patients with intensive care receive a nephrology consulting report and extensive information about acute kidney injury and the importance of ambulant follow-up care.
The investigators hypothesise a better in-hospital treatment and an improvement of clinical course in the interventional group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •men and women at the age of 18 or older
- •acute kidney injury according to KDIGO-guidelines
- •The patient (or his/ her authorised representative) is in the position and willing to give informed consent.
排除标准
- •Patients, who received kidney transplantation
- •Patients on chronic dialysis at the time of enrolment
- •Patients who are placed in an institution by judicial or governmental order
- •Pregnancy
- •Infection with HI- or Infektionen mit HI- oder Hepatitis virus infektion
- •Participation in a clinical study with testing on drugs or medical devices (according to German Medicines Law or Medicinal Devices Act)
研究组 & 干预措施
Control group
Patients with an acute kidney injury in laborytory testing receive usual care. Nephrology co-supervision only on enquiry of the ward physician
Interventional group
Patients with an acute kidney injury in laborytory testing receive nephrology co-supervision in hospital and information about the importance of ambulant follow-up care.
干预措施: Nephrology care bundle (Other)
结局指标
主要结局
MACE
时间窗: 12 months
major adverse cardiovascular event
次要结局
未报告次要终点