Effect of Medical Care on Health Status in Acute Kidney Injury (EMESA)

Medizinisches Versorgungszentrum Diaverum Potsdam

Status: Unknown

Conditions: Acute Renal Insufficiency

Treatments: Other: Nephrology care bundle

Study type: Interventional

Funder types: Other

Identifiers

NCT04929730

1.1

Details and patient eligibility

About

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").

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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600 participants in 2 patient groups

Control group

No Intervention group

Description:

Patients with an acute kidney injury in laborytory testing receive usual care. Nephrology co-supervision only on enquiry of the ward physician

Interventional group

Other group

Description:

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.

Treatment:

Other: Nephrology care bundle