Clinical trial NCT05275218: Effect of an Intervention to Prevent Acute Kidney Injury Versus Standard Care in High-risk Patients After Major Surgery
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Kidney Injury (Nontraumatic)
Keywords: surgery
biomarker
CCL14 protein
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2022-03-11
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Detailed description: 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)

Eligibility criteria: Inclusion Criteria:

1. Adult patients (age ≥18 years)
2. 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
3. Written informed consent

Exclusion Criteria:

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

Primary outcomes:
measure: Occurrence of persistent severe AKI
timeFrame: 72 hours after start of intervention
Secondary outcomes:
measure: Number of patients with major adverse kidney events (MAKE)
timeFrame: 90 days after start of intervention
measure: Length of intensive care unit stay
timeFrame: up to 90 days after start of intervention
measure: Hospital length of stay
timeFrame: up to 90 days after start of intervention
measure: Duration of renal replacement therapy
timeFrame: up to 28 days
measure: Rate of renal replacement therapy
timeFrame: up to 28 days
measure: Fluid balance
timeFrame: during intensive care unit stay
measure: Dose of vasopressors
timeFrame: during intensive care unit stay
measure: Duration of vasopressors
timeFrame: during hospital stay (up to 90 days after start of intervention)
measure: Rate of infection during intensive care unit stay
timeFrame: during intensive care unit stay (up to 28 days after start of intervention)
measure: Sequential organ failure assessment (SOFA) score
timeFrame: daily at days 1 to 14 after start of intervention
measure: Sequential organ failure assessment (SOFA) score
timeFrame: daily at day 1 to 14, day 21 and day 28
measure: Sequential organ failure assessment (SOFA) score
timeFrame: daily at days 28 after start of intervention
measure: Need of renal replacement therapy (RRT)
timeFrame: 28 days after start of intervention
measure: Need of renal replacement therapy (RRT)
timeFrame: 60 days after start of intervention
measure: Need of renal replacement therapy (RRT)
timeFrame: 90 days after start of intervention
measure: Need of renal replacement therapy (RRT)
timeFrame: 365 days after start of intervention
measure: Rate of mortality
timeFrame: 90 days after start of intervention
measure: Rate of mortality
timeFrame: 365 days after start of intervention
measure: Rate of persistent renal dysfunction
timeFrame: 90 days after start of intervention
measure: Rate of persistent renal dysfunction
timeFrame: 365 days after start of intervention
Other outcomes:
Locations:
city: Münster
country: Germany
facility: University Hospital Münster; 1Department of Anesthesiology, Intensive Care Medicine and Pain Medicine
Study officials:
affiliation: University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine
name: Zarbock, MD
role: STUDY_CHAIR
References: