Clinical trial NCT03244514: Biomarker-guided Implementation of the AKI Bundle
Official title: Biomarker-guided Implementation of the Cardiovascular (CV) Surgery AKI Bundle to Reduce the Occurrence of AKI After Cardiac Surgery- Prevention of AKI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury (Nontraumatic)
Keywords: cardiac surgery
KDIGO-Guideline
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: European Society of Intensive Care Medicine
First posted: 2017-08-09
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing cardiac surgery with cardiopulmonary bypass (CPB)
* Urinary \[TIMP-2\] \* \[IGFBP7\] \>= 0.3 4h after CPB
* Written informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Compliance rate
timeFrame: 48 hours after start of intervention
Secondary outcomes:
measure: Occurence of AKI
timeFrame: 72 hours after start of intervention
measure: Moderate and severe AKI
timeFrame: 72 hours after start of intervention
measure: Free-days through of vasoactive medications and mechanical ventilation
timeFrame: 28 days after start of intervention
measure: Renal recovery
timeFrame: 90 days after start of intervention
measure: Mortality
timeFrame: 90 days after start of intervention
measure: ICU and hospital stay
timeFrame: up to 1 year after start of intervention (until discharge)
measure: Number of patients with renal replacement therapy
timeFrame: 90 days after start of intervention
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann, Intensive Care Medicine
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Bochum
country: Germany
facility: Universitätsklinikum Bergmannsheil Bochum
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen, Klinik für Herz-, Kinderherz- und Gefäßchirurgie
city: Marburg
country: Germany
facility: Philipps-Universität Marburg
city: Muenster
country: Germany
facility: University Hospital Muenster
city: Milano
country: Italy
facility: Centro Cardiologico Monzino Istituto di Ricovero e Cura a Carattere Scientific
city: Milan
country: Italy
facility: Ospedale San Raffaele S.r.I., I.R.C.C.S.
city: Barcelona
country: Spain
facility: Hospital del la Santa Creu i Sant Pau; Unidad de Cuidados Intensivos
city: London
country: United Kingdom
facility: St. Thomas' Hospital
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: University Hospital Muenster, Dept. of Anesthesiology
name: Zarbock, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.