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

NCT05275218 | Recruiting

• 1 other identifier: 08-AnIt-21
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury (Nontraumatic)

Keywords

surgery; biomarker; CCL14 protein

Outcome Measures

Primary Outcomes (1)

• Occurrence 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 Outcomes (20)

• Number of patients with major adverse kidney events (MAKE)

  90 days after start of intervention

• Length of intensive care unit stay

  up to 90 days after start of intervention

• Hospital length of stay

  up to 90 days after start of intervention

• Duration of renal replacement therapy

  up to 28 days

• Rate of renal replacement therapy

  up to 28 days

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Procedure: Implementation of the KDIGO bundle)

Control Group

NO INTERVENTION

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%

Interventions

Implementation of the KDIGO bundle) PROCEDURE

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

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

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

Münster, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 40328648 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Zarbock, MD

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

  STUDY CHAIR

Central Study Contacts

Zarbock, MD

CONTACT

+49-251-8347252; aki@anit.uni-muenster.de

Meersch, MD

CONTACT

aki@anit.uni-muenster.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 11, 2022
• Study Start: March 22, 2023
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)