Skip to content

Effect of Medical Care on Health Status in Acute Kidney Injury

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04929730
Acronym
EMESA
Enrollment
600
Registered
2021-06-18
Start date
2019-04-08
Completion date
2023-11-30
Last updated
2022-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Insufficiency

Keywords

Nephrologists, Health Services, Outpatient, Patient Care Bundles

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.

Interventions

OTHERNephrology care bundle

Nephrology care bundle

Sponsors

Ernst von Bergmann Hospital
CollaboratorOTHER
University of Magdeburg
CollaboratorOTHER
Medizinisches Versorgungszentrum Diaverum Potsdam
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
MACE12 monthsmajor adverse cardiovascular event

Countries

Germany

Contacts

Primary ContactMichael Haase, Prof
michael.haase@med.ovgu.de49331280
Backup ContactSaban Elitok, Dr
saban.elitok@klinikumevb.de49331241

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026