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

Primary Purpose

Acute Renal Insufficiency

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Nephrology care bundle
Sponsored by
Medizinisches Versorgungszentrum Diaverum Potsdam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Renal Insufficiency focused on measuring Nephrologists, Health Services, Outpatient, Patient Care Bundles

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Ernst von Bergmann HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Control group

Interventional group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

MACE
major adverse cardiovascular event

Secondary Outcome Measures

Full Information

First Posted
June 1, 2021
Last Updated
April 4, 2022
Sponsor
Medizinisches Versorgungszentrum Diaverum Potsdam
Collaborators
Ernst von Bergmann Hospital, University of Magdeburg
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1. Study Identification

Unique Protocol Identification Number
NCT04929730
Brief Title
Effect of Medical Care on Health Status in Acute Kidney Injury
Acronym
EMESA
Official Title
Effect of Organisation of Medical Care on Health Status in Patients With Acute Kidney Injury
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2019 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medizinisches Versorgungszentrum Diaverum Potsdam
Collaborators
Ernst von Bergmann Hospital, University of Magdeburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Renal Insufficiency
Keywords
Nephrologists, Health Services, Outpatient, Patient Care Bundles

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
alternating cluster-randomised allocation of investigation-periods alternierende Cluster-randomisierte Zuordnung der Untersuchungszeiträume
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients with an acute kidney injury in laborytory testing receive usual care. Nephrology co-supervision only on enquiry of the ward physician
Arm Title
Interventional group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Nephrology care bundle
Intervention Description
Nephrology care bundle
Primary Outcome Measure Information:
Title
MACE
Description
major adverse cardiovascular event
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Haase, Prof
Phone
49331280
Ext
6911
Email
michael.haase@med.ovgu.de
First Name & Middle Initial & Last Name or Official Title & Degree
Saban Elitok, Dr
Phone
49331241
Ext
38502
Email
saban.elitok@klinikumevb.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Haase, Prof
Organizational Affiliation
Medizinische Fakultät d. Otto-v-Guericke-Universität Magdeburg, MVZ Diaverum Am Neuen Garten Potsdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ernst von Bergmann Hospital
City
Potsdam
State/Province
Brandenburg
ZIP/Postal Code
14467
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saban Elitok, Dr. med.
Phone
0049331241
Ext
38502
Email
saban.elitok@klinikumevb.de
First Name & Middle Initial & Last Name & Degree
Annemarie Albert, Dr. med.
Phone
0049331241
Ext
36341
Email
annemarie.albert@klinikumevb.de
First Name & Middle Initial & Last Name & Degree
Annemarie Albert, Dr. med.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28143633
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.
Results Reference
background
PubMed Identifier
27793961
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.
Results Reference
background
PubMed Identifier
28088774
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.
Results Reference
background
PubMed Identifier
24311708
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.
Results Reference
background

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Effect of Medical Care on Health Status in Acute Kidney Injury

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