NCT04929730

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").

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

3.6 years

First QC Date

June 1, 2021

Last Update Submit

April 4, 2022

Conditions

Acute Renal Insufficiency

Keywords

NephrologistsHealth Services, OutpatientPatient Care Bundles

Outcome Measures

Primary Outcomes (1)

  • MACE

    major adverse cardiovascular event

    12 months

Study Arms (2)

Control group

NO INTERVENTION

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

Interventional group

OTHER

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

Interventions

Nephrology care bundleOTHER

Nephrology care bundle

Interventional group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ernst von Bergmann Hospital

Potsdam, Brandenburg, 14467, Germany

RECRUITING

Related Publications (4)

  • 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.

    PMID: 28143633BACKGROUND

  • 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.

    PMID: 27793961BACKGROUND

  • 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.

    PMID: 28088774BACKGROUND

  • 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.

    PMID: 24311708BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Michael Haase, Prof

    Medizinische Fakultät d. Otto-v-Guericke-Universität Magdeburg, MVZ Diaverum Am Neuen Garten Potsdam

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Haase, Prof

CONTACT

49331280michael.haase@med.ovgu.de

Saban Elitok, Dr

CONTACT

49331241saban.elitok@klinikumevb.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: alternating cluster-randomised allocation of investigation-periods alternierende Cluster-randomisierte Zuordnung der Untersuchungszeiträume
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2021

First Posted

June 18, 2021

Study Start

April 8, 2019

Primary Completion

November 1, 2022

Study Completion

November 1, 2023

Last Updated

April 12, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)