Acute Kidney Injury (Nontraumatic)PrevAKI-mcNCT03244514
Biomarker-guided Implementation of the AKI Bundle
A study testing Intervention in people with Acute Kidney Injury (Nontraumatic), run by University Hospital Muenster at 12 sites in 5 countries.
Trial summary
There is no specific therapy for acute kidney injury. It is presumed that supportive measures improve the care and outcome of patients with acute kidney injury. The investigators hypothesize that the implementation of a bundle of supportive measures adapted to patients undergoing cardiovascular surgery reduces the… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Kidney Injury (Nontraumatic)
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 12 sitesin 5 countries
- Study dates
- 2 Nov 2017to 26 Jan 2020
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing cardiac surgery with cardiopulmonary bypass (CPB)
- Urinary [TIMP-2] * [IGFBP7] >= 0.3 4h after CPB
- Written informed consent
Who cannot join
- Preexisting AKI (stage 1 and higher)
- Patients with cardiac assist devices (ECMO, LVAD, RVAD, IABP)
- Pregnancy, breastfeeding
- Known (Glomerulo-)-Nephritis, intersstitial nephritis or vasculitis
- CKD with eGFR < 20 mL/min
- Dialyses dependent CKD
- Prior kidney transplant within the last 12 months
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
Germany4 sites
Universitätsklinikum Bergmannsheil Bochum
Bochum, D-44789
Universitätsklinikum Gießen, Klinik für Herz-, Kinderherz- und Gefäßchirurgie
Giessen, 35392
Philipps-Universität Marburg
Marburg, D-35033
University Hospital Muenster
Münster, D-48149
Belgium3 sites
CHU Brugmann, Intensive Care Medicine
Brussels, 1020
AZ Maria Middelares
Ghent, 9000
Universitair Ziekenhuis Gent
Ghent, 9000
Italy2 sites
Ospedale San Raffaele S.r.I., I.R.C.C.S.
Milan, 20132
Centro Cardiologico Monzino Istituto di Ricovero e Cura a Carattere Scientific
Milan, I-20138
United Kingdom2 sites
St. Thomas' Hospital
London, SE1 7EH
King's College Hospital
London, SE5 9RS
Spain1 site
Hospital del la Santa Creu i Sant Pau; Unidad de Cuidados Intensivos
Barcelona, 08041
About this study
Official title: Biomarker-guided Implementation of the Cardiovascular (CV) Surgery AKI Bundle to Reduce the Occurrence of AKI After Cardiac Surgery- Prevention of AKI
There is no specific therapy for acute kidney injury. It is presumed that supportive measures improve the care and outcome of patients with acute kidney injury.
The investigators hypothesize that the implementation of a bundle of supportive measures adapted to patients undergoing cardiovascular surgery reduces the occurence of AKI.
A Randomized prospective multicenter trial is needed to investigate whether the implementation of the bundle of measures is effective to prevent AKI in high risk patients undergoing cardiac surgery. In this feasibility trial the investigators will analyze the compliance rate to the trial protocol in a multicenter, multinational cohort in preparation for a large randomized controlled trial.
- Conditions
- Acute Kidney Injury (Nontraumatic)
- Being tested
- Intervention
- Keywords
- cardiac surgery, KDIGO-Guideline
- 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.
InterventionOther
Implementation of the cardiovascular AKI bundle (see arm description)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Implementation of the cardiovascular surgery AKI bundle
1. discontinuation of all nephrotoxic agents when possible
2. optimization of volume status and hemodynamic parameters
3. close monitoring of serum creatinine, fluid balance and urinary output
4. avoidance of hyperglycemia
5. considerations of alternatives to radiocontrast agents
6. discontinuation of angiotensin converting enzyme inhibitors and angiotensin receptor blockers in the perioperative period
7. avoidance of HES, gelatin, and chlorid-rich solutions Receives: Other: Intervention |
| Control group | No intervention | The patients will receive standard of care (according to each center) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance rate
proportion of patients who are treated according to the trial protocol: CV surgery AKI bundle fulfilled at all time
Measured: 48 hours after start of intervention
Secondary outcomes (7)
Occurence of AKI
Measured: 72 hours after start of intervention
Moderate and severe AKI
Measured: 72 hours after start of intervention
Free-days through of vasoactive medications and mechanical ventilation
Measured: 28 days after start of intervention
Renal recovery
renal recovery is defined as serum creatinine levels < 0.5 mg/dl higher than baseline serum creatinine (creatinine level before surgery)
Measured: 90 days after start of intervention
Mortality
Measured: 90 days after start of intervention
ICU and hospital stay
Measured: up to 1 year after start of intervention (until discharge)
Number of patients with renal replacement therapy
Measured: 90 days after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start2 Nov 2017
- Primary completion26 Oct 2019
- Study completion26 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney Injury (Nontraumatic)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Responsible party
- Sponsor
- Investigators
- Zarbock, PhD, Study chair, University Hospital Muenster, Dept. of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244514
- Sponsor's protocol ID
- 07-AnIt-16
- Acronym
- PrevAKI-mc
- Status last verified
- Feb 2020
- First submitted
- 7 Jul 2017
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meersch M, Schmidt C, Hoffmeier A, Van Aken H, Wempe C, Gerss J, Zarbock A. Prevention of cardiac surgery-associated AKI by implementing the KDIGO guidelines in high risk patients identified by biomarkers: the PrevAKI randomized controlled trial. Intensive Care Med. 2017 Nov;43(11):1551-1561. doi: 10.1007/s00134-016-4670-3. Epub 2017 Jan 21.
PubMed 28110412Zarbock A, Kullmar M, Ostermann M, Lucchese G, Baig K, Cennamo A, Rajani R, McCorkell S, Arndt C, Wulf H, Irqsusi M, Monaco F, Di Prima AL, Garcia Alvarez M, Italiano S, Miralles Bagan J, Kunst G, Nair S, L'Acqua C, Hoste E, Vandenberghe W, Honore PM, Kellum JA, Forni LG, Grieshaber P, Massoth C, Weiss R, Gerss J, Wempe C, Meersch M. Prevention of Cardiac Surgery-Associated Acute Kidney Injury by Implementing the KDIGO Guidelines in High-Risk Patients Identified by Biomarkers: The PrevAKI-Multicenter Randomized Controlled Trial. Anesth Analg. 2021 Aug 1;133(2):292-302. doi: 10.1213/ANE.0000000000005458.
PubMed 33684086Kullmar M, Massoth C, Ostermann M, Campos S, Grau Novellas N, Thomson G, Haffner M, Arndt C, Wulf H, Irqsusi M, Monaco F, Di Prima A, Garcia Alvarez M, Italiano S, Cegarra SanMartin V, Kunst G, Nair S, L'Acqua C, Hoste EAJ, Vandenberghe W, Honore PM, Kellum J, Forni L, Grieshaber P, Weiss R, Gerss J, Wempe C, Meersch M, Zarbock A. Biomarker-guided implementation of the KDIGO guidelines to reduce the occurrence of acute kidney injury in patients after cardiac surgery (PrevAKI-multicentre): protocol for a multicentre, observational study followed by randomised controlled feasibility trial. BMJ Open. 2020 Apr 6;10(4):e034201. doi: 10.1136/bmjopen-2019-034201.
PubMed 32265240
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker-guided Implementation of the Cardiovascular (CV) Surgery AKI Bundle to Reduce the Occurrence of AKI After Cardiac Surgery- Prevention of AKI
- ClinicalTrials.gov ID
- NCT03244514
- Acronym / sponsor ID
- PrevAKI-mc / 07-AnIt-16
- Conditions
- Acute Kidney Injury (Nontraumatic)
- Keywords
- cardiac surgery, KDIGO-Guideline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 26 Oct 2019 (actual)
- Study completion
- 26 Jan 2020 (actual)
- First posted
- 9 Aug 2017 (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.
There is no specific therapy for acute kidney injury. It is presumed that supportive measures improve the care and outcome of patients with acute kidney injury.
The investigators hypothesize that the implementation of a bundle of supportive measures adapted to patients undergoing cardiovascular surgery reduces the occurence of AKI.
A Randomized prospective multicenter trial is needed to investigate whether the implementation of the bundle of measures is effective to prevent AKI in high risk patients undergoing cardiac surgery. In this feasibility trial the investigators will analyze the compliance rate to the trial protocol in a multicenter, multinational cohort in preparation for a large randomized controlled trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: InterventionImplementation of the cardiovascular surgery AKI bundle 1. discontinuation of all nephrotoxic agents when possible 2. optimization of volume status and hemodynamic parameters 3. close monitoring of serum creatinine, fluid balance and urinary output 4. avoidance of hyperglycemia 5. considerations of alternatives to radiocontrast agents 6. discontinuation of angiotensin converting enzyme inhibitors and angiotensin receptor blockers in the perioperative period 7. avoidance of HES, gelatin, and chlorid-rich solutions |
| Control group | No intervention | –The patients will receive standard of care (according to each center) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients undergoing cardiac surgery with cardiopulmonary bypass (CPB)
- Urinary [TIMP-2] * [IGFBP7] >= 0.3 4h after CPB
- Written informed consent
Key exclusion criteria (7 listed)
- Preexisting AKI (stage 1 and higher)
- Patients with cardiac assist devices (ECMO, LVAD, RVAD, IABP)
- Pregnancy, breastfeeding
- Known (Glomerulo-)-Nephritis, intersstitial nephritis or vasculitis
- CKD with eGFR < 20 mL/min
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 |
|---|---|---|
| InterventionImplementation of the cardiovascular AKI bundle (see arm description) | Other | Intervention group |
Primary outcome
Compliance rate
Time frame: 48 hours after start of intervention
proportion of patients who are treated according to the trial protocol: CV surgery AKI bundle fulfilled at all time
7 secondary outcomes
Occurence of AKI
Time frame: 72 hours after start of intervention
Moderate and severe AKI
Time frame: 72 hours after start of intervention
Free-days through of vasoactive medications and mechanical ventilation
Time frame: 28 days after start of intervention
Renal recovery
Time frame: 90 days after start of intervention
Mortality
Time frame: 90 days after start of intervention
ICU and hospital stay
Time frame: up to 1 year after start of intervention (until discharge)
Number of patients with renal replacement therapy
Time frame: 90 days after start of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Background: PubMed 28110412Meersch M, Schmidt C, Hoffmeier A, Van Aken H, Wempe C, Gerss J, Zarbock A. Prevention of cardiac surgery-associated AKI by implementing the KDIGO guidelines in high risk patients identified by biomarkers: the PrevAKI randomized controlled trial. Intensive Care Med. 2017 Nov;43(11):1551-1561. doi: 10.1007/s00134-016-4670-3. Epub 2017 Jan 21.
- Derived from this study: PubMed 33684086Zarbock A, Kullmar M, Ostermann M, Lucchese G, Baig K, Cennamo A, Rajani R, McCorkell S, Arndt C, Wulf H, Irqsusi M, Monaco F, Di Prima AL, Garcia Alvarez M, Italiano S, Miralles Bagan J, Kunst G, Nair S, L'Acqua C, Hoste E, Vandenberghe W, Honore PM, Kellum JA, Forni LG, Grieshaber P, Massoth C, Weiss R, Gerss J, Wempe C, Meersch M. Prevention of Cardiac Surgery-Associated Acute Kidney Injury by Implementing the KDIGO Guidelines in High-Risk Patients Identified by Biomarkers: The PrevAKI-Multicenter Randomized Controlled Trial. Anesth Analg. 2021 Aug 1;133(2):292-302. doi: 10.1213/ANE.0000000000005458.
- Derived from this study: PubMed 32265240Kullmar M, Massoth C, Ostermann M, Campos S, Grau Novellas N, Thomson G, Haffner M, Arndt C, Wulf H, Irqsusi M, Monaco F, Di Prima A, Garcia Alvarez M, Italiano S, Cegarra SanMartin V, Kunst G, Nair S, L'Acqua C, Hoste EAJ, Vandenberghe W, Honore PM, Kellum J, Forni L, Grieshaber P, Weiss R, Gerss J, Wempe C, Meersch M, Zarbock A. Biomarker-guided implementation of the KDIGO guidelines to reduce the occurrence of acute kidney injury in patients after cardiac surgery (PrevAKI-multicentre): protocol for a multicentre, observational study followed by randomised controlled feasibility trial. BMJ Open. 2020 Apr 6;10(4):e034201. doi: 10.1136/bmjopen-2019-034201.
- 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.
Zarbock, PhD study chair
University Hospital Muenster, Dept. of Anesthesiology
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Acute Kidney Injury (Nontraumatic), run by University Hospital Muenster at 12 sites in 5 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 3 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: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Belgium, Italy, United Kingdom, Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance rate (time frame: 48 hours after start of intervention). 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 NCT03244514, which also lists 3 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 19 Feb 2020.