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NCT Number: NCT05275218

Effect of an Intervention to Prevent Acute Kidney Injury Versus Standard Care in High-risk Patients After Major Surgery

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.

To investigate whether an implementation of a supportive extended care "bundle" in high-risk patients for persistent acute kidney injury (AKI) can reduce the occurrence of persistent surgical AKI.

In order to investigate whether the extended KDIGO bundle can prevent persistent AKI in patients with high chemokine ligand 14 (CCL14) as well as in patients with low CCL14, patients will be randomized with stratification by the CCL-value.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Münster; 1Department of Anesthesiology, Intensive Care Medicine and Pain Medicine

Münster, Germany

Location status: Recruiting

About this study

All patients will receive standard of care therapy according to the standards of our center. After identifying surgical patients with a moderate or severe (stage 2 or 3) AKI patients will be randomly allocated to the control or intervention group according to the CCL14 results which will be measured as part of the study. According to the literature, patients with a CCL14 <1.3ng/ml are at low risk of progression and patients with a CCL14≥1.3ng/ml are at high risk of AKI progression. In order to have both patient groups included, we will have two groups (patients at low and at high risk of AKI progression) and these will be randomized to receive either standard of care or an extended KDIGO bundle (in total 4 groups).

Control intervention / reference test: Patients in the control groups will be treated according to the standard of care. The only two hemodynamic targets in this group are the mean arterial pressure (mean arterial pressure (MAP)>65mmHg) and passive leg raising test (PLRT) (increase of cardiac output (CO) <10%).

In the intervention groups, an extended KDIGO guideline bundle will be implemented (Discontinuation of all nephrotoxic agents when possible, optimization of volume status and perfusion pressure, consideration of a functional hemodynamic monitoring, close monitoring of serum creatinine and urine output, avoidance of hyperglycemia, consideration of alternatives to radio contrast agents, non-invasive or invasive diagnostic workup, nephrology consultation)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients (age ≥18 years)
  • Moderate or severe AKI ((defined by the 2012 KDIGO criteria, KDIGO stage 2 and 3), determined by either serum creatinine or urine output) within 72h after a surgical procedure
  • Written informed consent

Exclusion criteria

  • Dialysis-dependent chronic kidney disease
  • Prior kidney transplant
  • Infections with human immunodeficiency virus or hepatitis
  • Hepatorenal syndrome
  • Pregnancy or breast-feeding
  • Participation in another interventional trial that investigates a drug that affects the kidney function within the last 3 months
  • Persons held in an institution by legal or official order
  • Persons with any kind of dependency on the investigator or employed by the responsible institution or investigator

Treatment and study plan

Implementation of the KDIGO bundle)

Procedure

Comprehensive Implementation of the Bundle recommended by the "Kidney Disease: Improving Global Outcomes Group "(KDIGO bundle)

Primary outcomes

  1. Occurrence of persistent severe AKI

    Time frame: 72 hours after start of intervention

    The primary endpoint is the development of persistent severe (stage 3) AKI lasting for at least 72h defined as ≥3-fold increase in serum creatinine in relation to baseline or serum creatinine ≥4.0mg/dl with an acute increase of 0.5mg/dl or a decrease in urine output <0.3ml/kg/h for 24 hours or anuria for 12 hours. Persistent AKI is defined as follows: patients with stage 3 AKI at enrollment require a persistence of 72h or more to meet the endpoint. Patients enrolled at stage 2 AKI require a progression to stage 3 within 48 hours and a persistence at stage 3 for 72 consecutive hours to be considered endpoint positive. Additionally, patients with severe AKI who fail to achieve 72h due to death or the initiation of renal replacement therapy are considered endpoint positive as well

Secondary outcomes

  1. Number of patients with major adverse kidney events (MAKE)

    Time frame: 90 days after start of intervention

    Composite endpoint consisting of death or initiation of renal replacement therapy within 90 days or persistent renal dysfunction (defined as a decrease in estimated glomerular filtration rate (eGFR) to < 75% of baseline)

    • The baseline serum creatinine is taken as the value obtained prior to the day of operation
  2. Length of intensive care unit stay

    Time frame: up to 90 days after start of intervention

  3. Hospital length of stay

    Time frame: up to 90 days after start of intervention

  4. Duration of renal replacement therapy

    Time frame: up to 28 days

  5. Rate of renal replacement therapy

    Time frame: up to 28 days

  6. Fluid balance

    Time frame: during intensive care unit stay

  7. Dose of vasopressors

    Time frame: during intensive care unit stay

  8. Duration of vasopressors

    Time frame: during hospital stay (up to 90 days after start of intervention)

  9. Rate of infection during intensive care unit stay

    Time frame: during intensive care unit stay (up to 28 days after start of intervention)

  10. Sequential organ failure assessment (SOFA) score

    Time frame: daily at days 1 to 14 after start of intervention

  11. Sequential organ failure assessment (SOFA) score

    Time frame: daily at day 1 to 14, day 21 and day 28

  12. Sequential organ failure assessment (SOFA) score

    Time frame: daily at days 28 after start of intervention

  13. Need of renal replacement therapy (RRT)

    Time frame: 28 days after start of intervention

  14. Need of renal replacement therapy (RRT)

    Time frame: 60 days after start of intervention

  15. Need of renal replacement therapy (RRT)

    Time frame: 90 days after start of intervention

  16. Need of renal replacement therapy (RRT)

    Time frame: 365 days after start of intervention

  17. Rate of mortality

    Time frame: 90 days after start of intervention

  18. Rate of mortality

    Time frame: 365 days after start of intervention

  19. Rate of persistent renal dysfunction

    Time frame: 90 days after start of intervention

  20. Rate of persistent renal dysfunction

    Time frame: 365 days after start of intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Meersch, MD

CONTACT

[email protected]

Zarbock, MD

CONTACT

[email protected]

+49-251-8347252

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study title

Effect of an Extended "Kidney Disease: Improving Global Outcomes" (KDIGO) Bundle Versus Standard of Care Therapy on Persistent Acute Kidney Injury in High-risk Patients After Major Surgery

Acronym: PrevProgAKI

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 11, 2022
Registry last updated
Aug 1, 2024

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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