Ignite Creation Date:
2024-05-06 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05275218
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2022-02-17
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:
University Hospital Muenster
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 13ngml are at low risk of progression and patients with a CCL1413ngml 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 MAP65mmHg 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 MAP65mmHg 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:
None
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?:
None