Effect of Medical Care on Health Status in Acute Kidney Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-08

Study Completion Date

2023-11-30

Brief Summary

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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").

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Detailed Description

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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.

Conditions

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Acute Renal Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

alternating cluster-randomised allocation of investigation-periods alternierende Cluster-randomisierte Zuordnung der Untersuchungszeiträume

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type OTHER

Nephrology care bundle

Intervention Type OTHER

Nephrology care bundle

Interventions

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Nephrology care bundle

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No