Effect of Medical Care on Health Status in Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
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).

Detailed Description
-----------------
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.

Official Title
-----------------
Effect of Organisation of Medical Care on Health Status in Patients With Acute Kidney Injury

Conditions
-----------------
Acute Renal Insufficiency

Intervention / Treatment
-----------------
* Other: Nephrology care bundle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: alternating cluster-randomised allocation of investigation-periods alternierende Cluster-randomisierte Zuordnung der Untersuchungszeiträume
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Patients with an acute kidney injury in laborytory testing receive usual care. Nephrology co-supervision only on enquiry of the ward physician | |
| Other: Interventional group<br>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. | Other: Nephrology care bundle<br>* Nephrology care bundle<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | major adverse cardiovascular event | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nephrologists, Health Services, Outpatient, Patient Care Bundles