RecruitingNot ApplicableNCT05275218

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

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


Sponsor

University Hospital Muenster

Enrollment

480 participants

Start Date

Mar 22, 2023

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria8

  • 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

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Interventions

PROCEDUREImplementation of the KDIGO bundle)

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


Locations(1)

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

Münster, Germany

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NCT05275218


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