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Biomarker-guided Implementation of the AKI Bundle (PrevAKI-mc)

Primary Purpose

Acute Kidney Injury (Nontraumatic)

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Intervention
Sponsored by
University Hospital Muenster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Kidney Injury (Nontraumatic) focused on measuring cardiac surgery, KDIGO-Guideline

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Implementation of the cardiovascular surgery AKI bundle discontinuation of all nephrotoxic agents when possible optimization of volume status and hemodynamic parameters close monitoring of serum creatinine, fluid balance and urinary output avoidance of hyperglycemia considerations of alternatives to radiocontrast agents discontinuation of angiotensin converting enzyme inhibitors and angiotensin receptor blockers in the perioperative period avoidance of HES, gelatin, and chlorid-rich solutions

The patients will receive standard of care (according to each center)

Outcomes

Primary Outcome Measures

Compliance rate
proportion of patients who are treated according to the trial protocol: CV surgery AKI bundle fulfilled at all time

Secondary Outcome Measures

Occurence of AKI
Moderate and severe AKI
Free-days through of vasoactive medications and mechanical ventilation
Renal recovery
renal recovery is defined as serum creatinine levels < 0.5 mg/dl higher than baseline serum creatinine (creatinine level before surgery)
Mortality
ICU and hospital stay
Number of patients with renal replacement therapy

Full Information

First Posted
July 7, 2017
Last Updated
February 18, 2020
Sponsor
University Hospital Muenster
Collaborators
European Society of Intensive Care Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03244514
Brief Title
Biomarker-guided Implementation of the AKI Bundle
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 2, 2017 (Actual)
Primary Completion Date
October 26, 2019 (Actual)
Study Completion Date
January 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Muenster
Collaborators
European Society of Intensive Care Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury (Nontraumatic)
Keywords
cardiac surgery, KDIGO-Guideline

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Implementation of the cardiovascular surgery AKI bundle discontinuation of all nephrotoxic agents when possible optimization of volume status and hemodynamic parameters close monitoring of serum creatinine, fluid balance and urinary output avoidance of hyperglycemia considerations of alternatives to radiocontrast agents discontinuation of angiotensin converting enzyme inhibitors and angiotensin receptor blockers in the perioperative period avoidance of HES, gelatin, and chlorid-rich solutions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The patients will receive standard of care (according to each center)
Intervention Type
Other
Intervention Name(s)
Intervention
Intervention Description
Implementation of the cardiovascular AKI bundle (see arm description)
Primary Outcome Measure Information:
Title
Compliance rate
Description
proportion of patients who are treated according to the trial protocol: CV surgery AKI bundle fulfilled at all time
Time Frame
48 hours after start of intervention
Secondary Outcome Measure Information:
Title
Occurence of AKI
Time Frame
72 hours after start of intervention
Title
Moderate and severe AKI
Time Frame
72 hours after start of intervention
Title
Free-days through of vasoactive medications and mechanical ventilation
Time Frame
28 days after start of intervention
Title
Renal recovery
Description
renal recovery is defined as serum creatinine levels < 0.5 mg/dl higher than baseline serum creatinine (creatinine level before surgery)
Time Frame
90 days after start of intervention
Title
Mortality
Time Frame
90 days after start of intervention
Title
ICU and hospital stay
Time Frame
up to 1 year after start of intervention (until discharge)
Title
Number of patients with renal replacement therapy
Time Frame
90 days after start of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zarbock, PhD
Organizational Affiliation
University Hospital Muenster, Dept. of Anesthesiology
Official's Role
Study Chair
Facility Information:
Facility Name
CHU Brugmann, Intensive Care Medicine
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
AZ Maria Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitätsklinikum Bergmannsheil Bochum
City
Bochum
ZIP/Postal Code
D-44789
Country
Germany
Facility Name
Universitätsklinikum Gießen, Klinik für Herz-, Kinderherz- und Gefäßchirurgie
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Philipps-Universität Marburg
City
Marburg
ZIP/Postal Code
D-35033
Country
Germany
Facility Name
University Hospital Muenster
City
Muenster
ZIP/Postal Code
D-48149
Country
Germany
Facility Name
Centro Cardiologico Monzino Istituto di Ricovero e Cura a Carattere Scientific
City
Milano
ZIP/Postal Code
I-20138
Country
Italy
Facility Name
Ospedale San Raffaele S.r.I., I.R.C.C.S.
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Hospital del la Santa Creu i Sant Pau; Unidad de Cuidados Intensivos
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
St. Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28110412
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. Erratum In: Intensive Care Med. 2017 Mar 7;:
Results Reference
background
PubMed Identifier
33684086
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.
Results Reference
derived
PubMed Identifier
32265240
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.
Results Reference
derived

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Biomarker-guided Implementation of the AKI Bundle

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