Biomarker-guided Implementation of the AKI Bundle

Acute Kidney Injury (Nontraumatic) Clinical Trial

— PrevAKI-mc  

Official title:

Biomarker-guided Implementation of the Cardiovascular (CV) Surgery AKI Bundle to Reduce the Occurrence of AKI After Cardiac Surgery- Prevention of AKI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03244514
• Other study ID #: 07-AnIt-16
• Status: Completed
• Phase: N/A
• Start date: November 2, 2017
• Est. completion date: January 26, 2020

Study information

• Verified date: February 2020
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: January 26, 2020
• Est. primary completion date: October 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Kidney Injury (Nontraumatic)

Intervention

Other:
• Intervention
Implementation of the cardiovascular AKI bundle (see arm description)

Locations

Country	Name	City	State
Belgium	CHU Brugmann, Intensive Care Medicine	Brussels
Belgium	AZ Maria Middelares	Gent
Belgium	Universitair Ziekenhuis Gent	Gent
Germany	Universitätsklinikum Bergmannsheil Bochum	Bochum
Germany	Universitätsklinikum Gießen, Klinik für Herz-, Kinderherz- und Gefäßchirurgie	Gießen
Germany	Philipps-Universität Marburg	Marburg
Germany	University Hospital Muenster	Muenster
Italy	Ospedale San Raffaele S.r.I., I.R.C.C.S.	Milan
Italy	Centro Cardiologico Monzino Istituto di Ricovero e Cura a Carattere Scientific	Milano
Spain	Hospital del la Santa Creu i Sant Pau; Unidad de Cuidados Intensivos	Barcelona
United Kingdom	King's College Hospital	London
United Kingdom	St. Thomas' Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Muenster	European Society of Intensive Care Medicine

Countries where clinical trial is conducted

Belgium,  Germany,  Italy,  Spain,  United Kingdom, 

References & Publications (1)

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. Erratum in: Intensive Care Med. 2017 Mar 7;:. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance rate	proportion of patients who are treated according to the trial protocol: CV surgery AKI bundle fulfilled at all time	48 hours after start of intervention
Secondary	Occurence of AKI		72 hours after start of intervention
Secondary	Moderate and severe AKI		72 hours after start of intervention
Secondary	Free-days through of vasoactive medications and mechanical ventilation		28 days after start of intervention
Secondary	Renal recovery	renal recovery is defined as serum creatinine levels < 0.5 mg/dl higher than baseline serum creatinine (creatinine level before surgery)	90 days after start of intervention
Secondary	Mortality		90 days after start of intervention
Secondary	ICU and hospital stay		up to 1 year after start of intervention (until discharge)
Secondary	Number of patients with renal replacement therapy		90 days after start of intervention