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

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ClinicalTrials.gov Identifier: NCT05275218
Recruitment Status : Recruiting
First Posted : March 11, 2022
Last Update Posted : March 15, 2024
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
University Hospital Muenster

Study Description
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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.


Condition or disease Intervention/treatment Phase
Acute Kidney Injury (Nontraumatic) Procedure: Implementation of the KDIGO bundle) Not Applicable

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)

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : March 22, 2023
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Group
Implementation of the KDIGO bundle for at least 12 hours 1. discontinuation of all nephrotoxic drugs when possible 2. optimization of volume status and hemodynamic parameters (consideration of a functional hemodynamic monitoring) 3. close monitoring of serum creatinine, fluid balance and urinary output 4. avoidance of hyperglycemia 5. considerations of alternatives to radiocontrast agents 6. discontinuation of angiotensin converting enzyme inhibitors and angiotensin receptor blockers in the perioperative period 7. avoidance of hydroxyethyl starch, gelatin, and chlorid-rich solutions
 Procedure: Implementation of the KDIGO bundle)
Comprehensive Implementation of the Bundle recommended by the "Kidney Disease: Improving Global Outcomes Group "(KDIGO bundle)
No Intervention: Control Group

Patients in the control group will receive standard of care. According to best clinical practice, this includes the following targets (unless specific individual targets are chosen by treating physician):

  • mean arterial pressure (MAP): ≥ 65 mmHg
  • passive leg raising test (PLRT): increase of cardiac output (CO)<10%


Outcome Measures
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Primary Outcome Measures :
  1. Occurence 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 Outcome Measures :
  1. Number of patients with major adverse kidney events (MAKE) [ Time Frame: 90 days after start of intervention ]
    Composite endpoint consisting of death, initiation of renal replacement therapy, and persistent severe AKI lasting for 72 hours or more

  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 days 21 after start of intervention ]
  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. Rate of mortality [ Time Frame: 90 days after start of intervention ]
  17. Rate of persistent renal dysfunction [ Time Frame: 90 days after start of intervention ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05275218


Contacts
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Contact: Zarbock, MD +49-251-8347252 aki@anit.uni-muenster.de
Contact: Meersch, MD aki@anit.uni-muenster.de

Locations
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Germany
University Hospital Münster; 1Department of Anesthesiology, Intensive Care Medicine and Pain Medicine Recruiting
Münster, Germany
Sponsors and Collaborators
University Hospital Muenster
Baxter Healthcare Corporation
Investigators
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Study Chair: Zarbock, MD University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine
More Information
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Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT05275218    
Other Study ID Numbers: 08-AnIt-21
First Posted: March 11, 2022    Key Record Dates
Last Update Posted: March 15, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Muenster:
surgery
biomarker
CCL14 protein
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases
 Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases