Acute Renal InsufficiencyEMESANCT04929730
Effect of Medical Care on Health Status in Acute Kidney Injury
A study testing Nephrology care bundle in people with Acute Renal Insufficiency, run by Medizinisches Versorgungszentrum Diaverum Potsdam at 1 site in Germany.
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"). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Insufficiency
- What is being tested?
- Nephrology care bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteGermany
- Study dates
- 8 Apr 2019to Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Ernst von Bergmann Hospital
Potsdam, Brandenburg, 14467
Saban Elitok, Dr. med., 0049331241 ext. 38502, saban.elitok@klinikumevb.de
Annemarie Albert, Dr. med., 0049331241 ext. 36341, annemarie.albert@klinikumevb.de
About this study
Official title: 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").
Read the 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.
- Conditions
- Acute Renal Insufficiency
- Being tested
- Nephrology care bundle
- Keywords
- Nephrologists, Health Services, Outpatient, Patient Care Bundles
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nephrology care bundleOther
Nephrology care bundle
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Nephrology care bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
major adverse cardiovascular event
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start8 Apr 2019
- Primary completionNov 2022 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Renal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- alternating cluster-randomised allocation of investigation-periods alternierende Cluster-randomisierte Zuordnung der Untersuchungszeiträume
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medizinisches Versorgungszentrum Diaverum Potsdam
- Sponsor type
- University, hospital or other
- Collaborators
- Ernst von Bergmann Hospital, University of Magdeburg
- Responsible party
- Sponsor
- Investigators
- Michael Haase, Prof, Principal investigator, Medizinische Fakultät d. Otto-v-Guericke-Universität Magdeburg, MVZ Diaverum Am Neuen Garten Potsdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929730
- Sponsor's protocol ID
- 1.1
- Acronym
- EMESA
- Status last verified
- Apr 2022
- First submitted
- 1 Jun 2021
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28143633Holmes 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.
PubMed 27793961Lachance 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.
PubMed 28088774Chawla 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.
PubMed 24311708
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Organisation of Medical Care on Health Status in Patients With Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT04929730
- Acronym / sponsor ID
- EMESA / 1.1
- Conditions
- Acute Renal Insufficiency
- Keywords
- Nephrologists, Health Services, Outpatient, Patient Care Bundles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Medizinisches Versorgungszentrum Diaverum PotsdamUniversity, hospital or other
- Collaborators
- Ernst von Bergmann Hospital, University of Magdeburg
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- alternating cluster-randomised allocation of investigation-periods alternierende Cluster-randomisierte Zuordnung der Untersuchungszeiträume
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Nephrology care bundlePatients with an acute kidney injury in laborytory testing receive nephrology co-supervision in hospital and information about the importance of ambulant follow-up care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nephrology care bundleNephrology care bundle | Other | Interventional group |
Primary outcome
MACE
Time frame: 12 months
major adverse cardiovascular event
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Background: PubMed 28143633Haase 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.
- Background: PubMed 27793961Holmes 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.
- Background: PubMed 28088774Lachance 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.
- Background: PubMed 24311708Chawla 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Haase, Prof principal investigator
Medizinische Fakultät d. Otto-v-Guericke-Universität Magdeburg, MVZ Diaverum Am Neuen Garten Potsdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nephrology care bundle in people with Acute Renal Insufficiency, run by Medizinisches Versorgungszentrum Diaverum Potsdam at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Haase, Prof (49331280 ext. 6911, michael.haase@med.ovgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04929730, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.