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OpenTrials
Completed

NCT Number: NCT03244514

Biomarker-guided Implementation of the AKI Bundle

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.

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Key information

Conditions

Acute Kidney Injury (Nontraumatic) Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Brugmann, Intensive Care Medicine, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

Other

Implementation of the cardiovascular AKI bundle (see arm description)

Primary outcomes

  1. Compliance rate

    Time frame: 48 hours after start of intervention

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

Secondary outcomes

  1. Occurence of AKI

    Time frame: 72 hours after start of intervention

  2. Moderate and severe AKI

    Time frame: 72 hours after start of intervention

  3. Free-days through of vasoactive medications and mechanical ventilation

    Time frame: 28 days after start of intervention

  4. Renal recovery

    Time frame: 90 days after start of intervention

    renal recovery is defined as serum creatinine levels < 0.5 mg/dl higher than baseline serum creatinine (creatinine level before surgery)

  5. Mortality

    Time frame: 90 days after start of intervention

  6. ICU and hospital stay

    Time frame: up to 1 year after start of intervention (until discharge)

  7. Number of patients with renal replacement therapy

    Time frame: 90 days after start of intervention

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Collaborators

  • European Society of Intensive Care Medicine

Registry information

Official study title

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

Acronym: PrevAKI-mc

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Aug 9, 2017
Registry last updated
Feb 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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