Preventing kidney injury after major surgery
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
This study is testing if a special care plan can help prevent kidney problems in high-risk patients after major surgery compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 480 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Muenster Academic / other |
| Locations | 1 site (Münster) |
| Trial ID | NCT05275218 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of an extended care 'bundle' aimed at preventing persistent acute kidney injury (AKI) in high-risk surgical patients. Participants will be randomized into two groups based on their chemokine ligand 14 (CCL14) levels, which indicate their risk of AKI progression. Those in the intervention group will receive enhanced care protocols alongside standard treatment, while the control group will receive standard care only. The study aims to determine if the implementation of this bundle can significantly reduce the occurrence of persistent AKI.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have moderate to severe acute kidney injury within 72 hours after surgery.
Not a fit: Patients who are dialysis-dependent or have prior kidney transplants will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved kidney health and outcomes for patients undergoing major surgery.
How similar studies have performed: Previous studies have shown promise in using supportive care bundles to improve outcomes in similar patient populations, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Münster
- University Hospital Münster; 1Department of Anesthesiology, Intensive Care Medicine and Pain Medicine — Münster, Germany (Recruiting)
Study contacts
- Study coordinator: Zarbock, MD
- Email: aki@anit.uni-muenster.de
- Phone: +49-251-8347252
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.