Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT05275218
Status:
RECRUITING
Last Update Posted:
2024-08-01
First Post:
2022-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of an Intervention to Prevent Acute Kidney Injury Versus Standard Care in High-risk Patients After Major Surgery
Sponsor:
University Hospital Muenster
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PrevProgAKI
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.
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)
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)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: