Clinical trial NCT04929730: Effect of Medical Care on Health Status in Acute Kidney Injury
Official title: Effect of Organisation of Medical Care on Health Status in Patients With Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Renal Insufficiency
Keywords: Nephrologists
Health Services, Outpatient
Patient Care Bundles
Lead sponsor: Medizinisches Versorgungszentrum Diaverum Potsdam
Sponsor class: OTHER
Collaborators: name: Ernst von Bergmann Hospital
name: University of Magdeburg
First posted: 2021-06-18
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: alternating cluster-randomised allocation of investigation-periods alternierende Cluster-randomisierte Zuordnung der Untersuchungszeiträume
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: MACE
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Potsdam
country: Germany
facility: Ernst von Bergmann Hospital
state: Brandenburg
Study officials:
affiliation: Medizinische Fakultät d. Otto-v-Guericke-Universität Magdeburg, MVZ Diaverum Am Neuen Garten Potsdam
name: Michael Haase, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haase M, Kribben A, Zidek W, Floege J, Albert C, Isermann B, Robra BP, Haase-Fielitz A. Electronic Alerts for Acute Kidney Injury. Dtsch Arztebl Int. 2017 Jan 9;114(1-02):1-8. doi: 10.3238/arztebl.2017.0001.
citation: Holmes J, Rainer T, Geen J, Roberts G, May K, Wilson N, Williams JD, Phillips AO; Welsh AKI Steering Group. Acute Kidney Injury in the Era of the AKI E-Alert. Clin J Am Soc Nephrol. 2016 Dec 7;11(12):2123-2131. doi: 10.2215/CJN.05170516. Epub 2016 Oct 28.
citation: Lachance P, Villeneuve PM, Rewa OG, Wilson FP, Selby NM, Featherstone RM, Bagshaw SM. Association between e-alert implementation for detection of acute kidney injury and outcomes: a systematic review. Nephrol Dial Transplant. 2017 Feb 1;32(2):265-272. doi: 10.1093/ndt/gfw424.
citation: Chawla LS, Amdur RL, Shaw AD, Faselis C, Palant CE, Kimmel PL. Association between AKI and long-term renal and cardiovascular outcomes in United States veterans. Clin J Am Soc Nephrol. 2014 Mar;9(3):448-56. doi: 10.2215/CJN.02440213. Epub 2013 Dec 5.