University Hospital Münster; 1Department of Anesthesiology, Intensive Care Medicine and Pain Medicine
Münster, Germany
Location status: Recruiting
NCT Number: NCT05275218
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Münster, Germany
Location status: Recruiting
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)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Comprehensive Implementation of the Bundle recommended by the "Kidney Disease: Improving Global Outcomes Group "(KDIGO bundle)
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
Time frame: 90 days after start of intervention
Composite endpoint consisting of death or initiation of renal replacement therapy within 90 days or persistent renal dysfunction (defined as a decrease in estimated glomerular filtration rate (eGFR) to < 75% of baseline)
Time frame: up to 90 days after start of intervention
Time frame: up to 90 days after start of intervention
Time frame: up to 28 days
Time frame: up to 28 days
Time frame: during intensive care unit stay
Time frame: during intensive care unit stay
Time frame: during hospital stay (up to 90 days after start of intervention)
Time frame: during intensive care unit stay (up to 28 days after start of intervention)
Time frame: daily at days 1 to 14 after start of intervention
Time frame: daily at day 1 to 14, day 21 and day 28
Time frame: daily at days 28 after start of intervention
Time frame: 28 days after start of intervention
Time frame: 60 days after start of intervention
Time frame: 90 days after start of intervention
Time frame: 365 days after start of intervention
Time frame: 90 days after start of intervention
Time frame: 365 days after start of intervention
Time frame: 90 days after start of intervention
Time frame: 365 days after start of intervention
Contact information is provided by the study sponsor or research team.
University Hospital Muenster
Other
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
Acronym: PrevProgAKI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07447791
Acute Kidney Injury, Acute Kidney Injury (Nontraumatic)
London, Greater London, United Kingdom
View Trial DetailsNCT06259760
Acute Kidney Injury, Acute Kidney Injury (Nontraumatic)
Kaohsiung City, Sanmin Dist, Taiwan
View Trial DetailsNCT07467889
Acute Kidney Injury, Acute Kidney Injury (Nontraumatic)
Ankara, keçiören, Turkey (Türkiye)
View Trial DetailsNCT05612802
Acute Kidney Injury, Acute Kidney Injury (Nontraumatic)
Ankara, Turkey (Türkiye)
View Trial Details