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

Acute Kidney Injury (Nontraumatic) Clinical Trial

— PrevProgAKI  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05275218
• Other study ID #: 08-AnIt-21
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2023
• Est. completion date: May 2025

Study information

• Verified date: March 2024
• Source: University Hospital Muenster
• Contact: Zarbock, MD
• Phone: +49-251-8347252
• Email: aki[@]anit.uni-muenster.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: May 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Kidney Injury (Nontraumatic)
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital Münster; 1Department of Anesthesiology, Intensive Care Medicine and Pain Medicine	Münster

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Muenster	Baxter Healthcare Corporation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of persistent severe AKI	- 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	72 hours after start of intervention
Secondary	Number of patients with major adverse kidney events (MAKE)	Composite endpoint consisting of death, initiation of renal replacement therapy, and persistent severe AKI lasting for 72 hours or more	90 days after start of intervention
Secondary	Length of intensive care unit stay		up to 90 days after start of intervention
Secondary	Hospital length of stay		up to 90 days after start of intervention
Secondary	Duration of renal replacement therapy		up to 28 days
Secondary	Rate of renal replacement therapy		up to 28 days
Secondary	Fluid balance		during intensive care unit stay
Secondary	Dose of vasopressors		during intensive care unit stay
Secondary	Duration of vasopressors		during hospital stay (up to 90 days after start of intervention)
Secondary	Rate of infection during intensive care unit stay		during intensive care unit stay (up to 28 days after start of intervention)
Secondary	Sequential organ failure assessment (SOFA) score		daily at days 1 to 14 after start of intervention
Secondary	Sequential organ failure assessment (SOFA) score		daily at days 21 after start of intervention
Secondary	Sequential organ failure assessment (SOFA) score		daily at days 28 after start of intervention
Secondary	Need of renal replacement therapy (RRT)		28 days after start of intervention
Secondary	Need of renal replacement therapy (RRT)		60 days after start of intervention
Secondary	Need of renal replacement therapy (RRT)		90 days after start of intervention
Secondary	Rate of mortality		90 days after start of intervention
Secondary	Rate of persistent renal dysfunction		90 days after start of intervention