Effect of Medical Care on Health Status in Acute Kidney Injury

Acute Renal Insufficiency Clinical Trial

— EMESA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04929730
• Other study ID #: 1.1
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2019
• Est. completion date: November 2023

Study information

• Verified date: April 2022
• Source: Medizinisches Versorgungszentrum Diaverum Potsdam
• Contact: Michael Haase, Prof
• Phone: 49331280
• Email: michael.haase[@]med.ovgu.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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").

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: November 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Insufficiency
• Renal Insufficiency

Intervention

Other:
• Nephrology care bundle
Nephrology care bundle

Locations

Country	Name	City	State
Germany	Ernst von Bergmann Hospital	Potsdam	Brandenburg

Sponsors (3)

Lead Sponsor	Collaborator
Medizinisches Versorgungszentrum Diaverum Potsdam	Ernst von Bergmann Hospital, University of Magdeburg

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View 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. Review. — View 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. Epub 2016 Oct 28. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE	major adverse cardiovascular event	12 months