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

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

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").

Study Overview

• Status: Recruiting
• Conditions: Acute Renal Insufficiency
• Intervention / Treatment: Other: Nephrology care bundle

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.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Haase, Prof; Phone Number: 6911 49331280; Email: michael.haase@med.ovgu.de
• Study Contact Backup: Name: Saban Elitok, Dr; Phone Number: 38502 49331241; Email: saban.elitok@klinikumevb.de

Study Locations

• Germany
  • Brandenburg
    • Potsdam, Brandenburg, Germany, 14467
      • Recruiting
      • Ernst von Bergmann Hospital
      • Contact: Saban Elitok, Dr. med.; Phone Number: 38502 0049331241; Email: saban.elitok@klinikumevb.de
      • Contact: Annemarie Albert, Dr. med.; Phone Number: 36341 0049331241; Email: annemarie.albert@klinikumevb.de
      • Sub-Investigator: Annemarie Albert, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Patients with an acute kidney injury in laborytory testing receive usual care. Nephrology co-supervision only on enquiry of the ward physician
Other: 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.	Other: Nephrology care bundle; Nephrology care bundle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	major adverse cardiovascular event	12 months

Collaborators and Investigators

• Sponsor: Medizinisches Versorgungszentrum Diaverum Potsdam
• Collaborators: University of Magdeburg; Ernst von Bergmann Hospital
• Investigators: Principal Investigator: Michael Haase, Prof, Medizinische Fakultät d. Otto-v-Guericke-Universität Magdeburg, MVZ Diaverum Am Neuen Garten Potsdam

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2019
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Patient Care Bundles; Nephrologists; Health Services, Outpatient
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: 1.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No