NCT03244514

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
5 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 9, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

November 2, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2020

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

July 7, 2017

Last Update Submit

February 18, 2020

Conditions

Acute Kidney Injury (Nontraumatic)

Keywords

cardiac surgeryKDIGO-Guideline

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Occurence of AKI

    72 hours after start of intervention

  • Moderate and severe AKI

    72 hours after start of intervention

  • Free-days through of vasoactive medications and mechanical ventilation

    28 days after start of intervention

  • Renal recovery

    90 days after start of intervention

  • Mortality

    90 days after start of intervention

  • +2 more secondary outcomes

Study Arms (2)

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

Other: Intervention

Control group

NO INTERVENTION

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

Interventions

InterventionOTHER

Implementation of the cardiovascular AKI bundle (see arm description)

Intervention group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

CHU Brugmann, Intensive Care Medicine

Brussels, 1020, Belgium

Location

AZ Maria Middelares

Ghent, 9000, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Universitätsklinikum Bergmannsheil Bochum

Bochum, D-44789, Germany

Location

Universitätsklinikum Gießen, Klinik für Herz-, Kinderherz- und Gefäßchirurgie

Giessen, 35392, Germany

Location

Philipps-Universität Marburg

Marburg, D-35033, Germany

Location

University Hospital Muenster

Münster, D-48149, Germany

Location

Ospedale San Raffaele S.r.I., I.R.C.C.S.

Milan, 20132, Italy

Location

Centro Cardiologico Monzino Istituto di Ricovero e Cura a Carattere Scientific

Milan, I-20138, Italy

Location

Hospital del la Santa Creu i Sant Pau; Unidad de Cuidados Intensivos

Barcelona, 08041, Spain

Location

St. Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 28110412BACKGROUND

  • 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.

    PMID: 33684086DERIVED

  • 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.

    PMID: 32265240DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Methods

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Zarbock, PhD

    University Hospital Muenster, Dept. of Anesthesiology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2017

First Posted

August 9, 2017

Study Start

November 2, 2017

Primary Completion

October 26, 2019

Study Completion

January 26, 2020

Last Updated

February 19, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(3)DE(4)IT(2)ES(1)GB(2)