Study Results
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Basic Information
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COMPLETED
NA
280 participants
INTERVENTIONAL
2017-11-02
2020-01-26
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Intervention group
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
Intervention
Implementation of the cardiovascular AKI bundle (see arm description)
Control group
The patients will receive standard of care (according to each center)
No interventions assigned to this group
Interventions
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Intervention
Implementation of the cardiovascular AKI bundle (see arm description)
Eligibility Criteria
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Inclusion Criteria
* Urinary \[TIMP-2\] \* \[IGFBP7\] \>= 0.3 4h after CPB
* Written informed consent
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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European Society of Intensive Care Medicine
OTHER
University Hospital Muenster
OTHER
Responsible Party
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Principal Investigators
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Zarbock, PhD
Role: STUDY_CHAIR
University Hospital Muenster, Dept. of Anesthesiology
Locations
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CHU Brugmann, Intensive Care Medicine
Brussels, , Belgium
AZ Maria Middelares
Ghent, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Universitätsklinikum Bergmannsheil Bochum
Bochum, , Germany
Universitätsklinikum Gießen, Klinik für Herz-, Kinderherz- und Gefäßchirurgie
Giessen, , Germany
Philipps-Universität Marburg
Marburg, , Germany
University Hospital Muenster
Münster, , Germany
Ospedale San Raffaele S.r.I., I.R.C.C.S.
Milan, , Italy
Centro Cardiologico Monzino Istituto di Ricovero e Cura a Carattere Scientific
Milan, , Italy
Hospital del la Santa Creu i Sant Pau; Unidad de Cuidados Intensivos
Barcelona, , Spain
St. Thomas' Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Countries
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References
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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.
Zarbock 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.
Kullmar 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.
Other Identifiers
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07-AnIt-16
Identifier Type: -
Identifier Source: org_study_id
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