Acute Kidney InjuryKDIGO-BundleNCT06472999
Nephroprotective Measures in Critically Ill Patients With Moderate/Severe Acute Kidney Injury
An observational study of Acute Kidney Injury, run by Universität Münster at 3 sites in 3 countries.
Trial summary
This study investigates to which extent recommended nephroprotective measures are implemented in critically ill patients with moderate or severe acute kidney injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Nephroprotective measures
- Type of treatment
- Surgery or procedure
- How many people
- 257 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 24 Jul 2024to Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Critically ill patients (intensive care unit of the participating study sites)
Who may be able to join
- Critically ill patients with moderate or severe AKI (KDIGO stage 2 / 3)
- Requirement of vasopressors or mechanical ventilation
- Age ≥ 18 years
- Informed consent
Who cannot join
- Chronic kidney disease (CKD) with a glomerular filtration rate < 20ml/min
- Chronic dialysis dependency
- History of renal transplantation
- Permanent ligation of the renal arteries
- AKI immediately following nephrectomy
- Patients requiring permanent administration of nephrotoxic drugs (e.g. immunosuppressive therapy afer liver transplantation)
- Persons with any kind of dependency on the investigator or employed by the sponsor or investigator.
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Austria1 site, 1 recruiting
- Recruiting
Universitätsklinik Innsbruck
Innsbruck, 6020
Germany1 site, 1 recruiting
- Recruiting
University Hospital Münster; Department of Anesthesiology, Intensive Care Medicine and Pain Medicine
Münster, 48149
Meersch, MD, aki@uni-muenster.de
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University medical cener
Nijmegen, 6500
About this study
Official title: Implementation of Nephroprotective Measures in Critically Ill Patients With Moderate/Severe Acute Kidney Injury (AKI) - an Observational Study
This study investigates to which extent recommended nephroprotective measures are implemented in critically ill patients with moderate or severe acute kidney injury.
Read the detailed description
Acute kidney injury (AKI) is a global problem affecting more than 10% of all hospitalized patients and up to 50% of critically ill patients, with survival related not only to the severity,1 but also to the duration of renal dysfunction.2 Recent evidence suggests that two-thirds of patients with AKI resolve their renal dysfunction within 3-7 days whereas those in whom renal dysfunctions persist have dramatically reduced survival over the following year.2 Persistence of AKI is of grave importance in that it increases an individual's risk of developing chronic kidney disease (CKD) which is a major cause of morbidity and mortality. This link between AKI and CKD has been established over the last decade3 and specific recommendations for the management of patients with AKI have been proposed in order to potentially influence this transition.4 To date, there are no specific pharmacological options for preventing or treating AKI, which is why new approaches and intensive efforts are urgently needed to reduce the occurrence of AKI. The Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guidelines recommend implementing a bundle of different supportive measures, which, in theory, should be initiated in all patients with AKI in order to prevent disease progression. However, clinical practice and recent studies have shown that the implementation of the KDIGO bundle is still not standard clinical practice despite the fact that evidence suggest clear effectiveness in the reduction of AKI rates.5-9 Poor implementation of nephroprotective measures presents a major missed opportunity to reduce AKI-related morbidity and mortality and to improve long-term outcomes. To investigate the extent to which nephroprotective measures are implemented in patients with AKI can reduce the occurrence of persistent surgical AKI, a multi-center prospective cohort study will be performed.
- Conditions
- Acute Kidney Injury
- Being tested
- Nephroprotective measures
- Keywords
- Acute Kidney Injury, KDIGO, Nephroprotective, Bundle
- 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.
Nephroprotective measuresProcedure or surgery
Due to the observational design of the study, no study specific interventions are performed. The treatment of the patients is completely guided by the responsible physicians.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients | Not described Receives: Procedure: Nephroprotective measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients in whom "Kidney Disease: Improving Global Outcomes (KDIGO)" guideline recommendations are successfully implemented for 48 hours, following the onset of moderate/ severe AKI (defined by KDIGO criteria)
Measured: 60 hours after onset of moderate/severe AKI
Secondary outcomes (2)
Severity of Acute Kidney Injury
Severity of AKI (worst Acute Kidney Injury (AKI) stage according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria, with stage 1 being the least and stage 3 being the most severe stage)
Measured: within 72 hours after diagnosis
Duration of AKI (Acute Kidney Injury)
transient AKI (< 48 hours), persistent AKI (48 hours - 7 days) or acute kidney disease (AKD) (> 7 days)
Measured: from onset of AKI until follow-up day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start24 Jul 2024
- Primary completionMar 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 257 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Münster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Zarbock, MD, Principal investigator, University Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472999
- Sponsor's protocol ID
- AnIt23-10
- Acronym
- KDIGO-Bundle
- Status last verified
- Dec 2024
- First submitted
- 11 Jun 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Nephroprotective Measures in Critically Ill Patients With Moderate/Severe Acute Kidney Injury (AKI) - an Observational Study
- ClinicalTrials.gov ID
- NCT06472999
- Acronym / sponsor ID
- KDIGO-Bundle / AnIt23-10
- Conditions
- Acute Kidney Injury
- Keywords
- Acute Kidney Injury, KDIGO, Nephroprotective, Bundle
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 257 participants (estimated)
- Lead sponsor
- Universität MünsterUniversity, hospital or other
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 25 Jun 2024 (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.
This study investigates to which extent recommended nephroprotective measures are implemented in critically ill patients with moderate or severe acute kidney injury.
Detailed description
Acute kidney injury (AKI) is a global problem affecting more than 10% of all hospitalized patients and up to 50% of critically ill patients, with survival related not only to the severity,1 but also to the duration of renal dysfunction.2 Recent evidence suggests that two-thirds of patients with AKI resolve their renal dysfunction within 3-7 days whereas those in whom renal dysfunctions persist have dramatically reduced survival over the following year.2 Persistence of AKI is of grave importance in that it increases an individual's risk of developing chronic kidney disease (CKD) which is a major cause of morbidity and mortality. This link between AKI and CKD has been established over the last decade3 and specific recommendations for the management of patients with AKI have been proposed in order to potentially influence this transition.4 To date, there are no specific pharmacological options for preventing or treating AKI, which is why new approaches and intensive efforts are urgently needed to reduce the occurrence of AKI. The Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guidelines recommend implementing a bundle of different supportive measures, which, in theory, should be initiated in all patients with AKI in order to prevent disease progression. However, clinical practice and recent studies have shown that the implementation of the KDIGO bundle is still not standard clinical practice despite the fact that evidence suggest clear effectiveness in the reduction of AKI rates.5-9 Poor implementation of nephroprotective measures presents a major missed opportunity to reduce AKI-related morbidity and mortality and to improve long-term outcomes. To investigate the extent to which nephroprotective measures are implemented in patients with AKI can reduce the occurrence of persistent surgical AKI, a multi-center prospective cohort study will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients | – | Procedure: Nephroprotective measures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients (intensive care unit of the participating study sites)
Key inclusion criteria (4 listed)
- Critically ill patients with moderate or severe AKI (KDIGO stage 2 / 3)
- Requirement of vasopressors or mechanical ventilation
- Age ≥ 18 years
- Informed consent
Key exclusion criteria (7 listed)
- Chronic kidney disease (CKD) with a glomerular filtration rate < 20ml/min
- Chronic dialysis dependency
- History of renal transplantation
- Permanent ligation of the renal arteries
- AKI immediately following nephrectomy
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 |
|---|---|---|
| Nephroprotective measuresDue to the observational design of the study, no study specific interventions are performed. The treatment of the patients is completely guided by the responsible physicians. | Procedure or surgery | Critically ill patients |
Primary outcome
Rate of patients in whom "Kidney Disease: Improving Global Outcomes (KDIGO)" guideline recommendations are successfully implemented for 48 hours, following the onset of moderate/ severe AKI (defined by KDIGO criteria)
Time frame: 60 hours after onset of moderate/severe AKI
2 secondary outcomes
Severity of Acute Kidney Injury
Time frame: within 72 hours after diagnosis
Duration of AKI (Acute Kidney Injury)
Time frame: from onset of AKI until follow-up day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- 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.
Alexander Zarbock, MD principal investigator
University Münster
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Universität Münster at 3 sites in 3 countries.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria, Germany, Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melanie Meersch-Dini, MD (+492518347255, meersch@uni-muenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients in whom "Kidney Disease: Improving Global Outcomes (KDIGO)" guideline recommendations are successfully implemented for 48 hours, following the onset of moderate/ severe AKI (defined by KDIGO criteria) (time frame: 60 hours after onset of moderate/severe AKI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2024.