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

NCT ID: NCT05275218

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-22
• Study Completion Date: 2025-12-31

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)

Conditions

Acute Kidney Injury (Nontraumatic)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Group

Implementation of the KDIGO bundle for at least 72 hours 1. Discontinuation of all nephrotoxic drugs when possible 2. Optimization of volume status and perfusion pressure. 3. Consideration of a functional hemodynamic monitoring. 4.Close monitoring of serum creatinine, and urinary output 5. Avoidance of hyperglycemia 6. Considerations of alternatives to radiocontrast agents 7. Non-invasive or invasive diagnostic workup 8. Nephrology consultation.

Group Type: EXPERIMENTAL

Implementation of the KDIGO bundle)

Intervention Type: PROCEDURE

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

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%

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Implementation of the KDIGO bundle)

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

University Hospital Muenster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zarbock, MD

Role: STUDY_CHAIR

University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine

Locations

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

Münster, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Zarbock, MD

Role: CONTACT

aki@anit.uni-muenster.de

+49-251-8347252

Meersch, MD

Role: CONTACT

aki@anit.uni-muenster.de

References

Sadjadi M, Strauss C, von Groote T, Booke H, Schone LM, Sauermann L, Wempe C, Gerss J, Kellum J, Meersch M, Zarbock A. Effects of an extended therapeutic strategy versus standard-of-care therapy on persistent acute kidney injury in high-risk patients after major surgery: study protocol for the randomised controlled single-centre PrevProgAKI trial. BMJ Open. 2025 May 6;15(5):e097333. doi: 10.1136/bmjopen-2024-097333.

Reference Type: DERIVED

PMID: 40328648 (View on PubMed)

Other Identifiers

08-AnIt-21

Identifier Type: -

Identifier Source: org_study_id