Actively Recruiting
Led by University Hospital Muenster · Updated on 2024-08-01
480
Participants Needed
1
Research Sites
13 weeks
Total Duration
U
University Hospital Muenster
Lead Sponsor
B
Baxter Healthcare Corporation
Collaborating Sponsor
Researchers are investigating whether an extended supportive care approach, called the KDIGO bundle, can reduce the occurrence of persistent acute kidney injury (AKI) in high-risk patients after major surgery. This research focuses on patients who develop moderate or severe AKI shortly after surgery and aims to compare outcomes for those with different levels of the biomarker chemokine ligand 14 (CCL14), which indicates risk of AKI progression. Patients will be randomized based on their CCL14 levels to receive either standard care or the extended KDIGO bundle. The study involves two main groups: one receiving standard care, which focuses on maintaining certain blood pressure and heart function targets, and another receiving the extended KDIGO bundle. The KDIGO bundle includes stopping harmful kidney drugs when possible, optimizing fluid and blood pressure levels, close monitoring of kidney function through serum creatinine and urine output, avoiding high blood sugar, considering alternatives to contrast agents, performing diagnostic tests as needed, and consulting nephrology specialists. Patients will receive these interventions for at least 72 hours. Participants will be closely monitored with various assessments including kidney function tests, fluid balance, use of vasopressors, and organ failure scores daily for up to 28 days or longer. Outcomes measured include the occurrence of persistent severe AKI after 72 hours, kidney-related complications up to 90 days, length of hospital and ICU stays, need and duration of kidney replacement therapy, infection rates, and mortality at 90 and 365 days. The total participation time varies depending on follow-up assessments extending up to one year after intervention start.
CONDITIONS
Effect of an Intervention to Prevent Acute Kidney Injury Versus Standard Care in High-risk Patients After Major Surgery
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Complete this quick 3-step screening to check your eligibility
Duration - Up to 72 hours after surgery
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 72 hours
Participants are randomly assigned to receive either the extended KDIGO bundle or standard care to prevent progression of acute kidney injury after major surgery.
Daily monitoring during treatment period
Duration - Up to 90 days
Participants are monitored for outcomes such as kidney function, organ failure, infection, and survival for up to 90 days after treatment starts.
Regular assessments during intensive care unit and hospital stay, with follow-up visits as needed
Total: 1 location
1
University Hospital Münster; 1Department of Anesthesiology, Intensive Care Medicine and Pain Medicine
Münster, Germany
Actively Recruiting
Z
Zarbock, MD
M
Meersch, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Mahan Sadjadi, Christian Strauß, Thilo von Groote...
https://pubmed.ncbi.nlm.nih.gov/40328648