Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446739
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-04-16
Brief Title:
LoW Dose-Intensity vs Standard Dose-Intensity COntinuous Renal ReplaceMent Therapy in Critically Ill Patients WISDOM
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
LoW Dose-Intensity vs Standard Dose-Intensity COntinuous Renal ReplaceMent Therapy in Critically Ill Patients WISDOM A Pilot Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
WISDOM
Brief Summary:
An estimated 10-15 of critically ill patients with acute kidney failure in the intensive care unit receive acute dialysis therapy The majority of these patients initially receive a continuous form of dialysis therapy call continuous renal replacement therapy CRRT Prior studies have suggested that higher CRRT dose-intensity improved health outcomes for these patients however this was not found in high-quality clinical trials These more recent trials suggested a lower range of dose-intensity compared with the higher range as the new standard of care This was incorporated into guidelines To date no clinical trials have evaluated this lower range and specifically it is plausible that an even lower dose-intensity of CRRT may be well tolerated safe associated with similar outcomes and be more cost-effective This is the objective of the WISDOM trial to compare the guideline standard with lower dose-intensity among patients who are started on CRRT in the intensive care unit
Detailed Description:
Purpose To primarily determine whether a lower CRRT dose-intensity in critically ill patients with acute kidney injury AKI is non-inferior to standard CRRT dose-intensity and to secondarily determined whether lower CRRT dose intensity will shorten total CRRT duration and improve kidney recovery compared with standard CRRT dose-intensity
Hypothesis The primary hypothesis of the WISDOM trial is that lower CRRT dose-intensity is non-inferior to current standard guideline-directed CRRT dose-intensity for critically ill patients with AKI with respect to duration of CRRT and successful liberation from RRT and kidney recovery The secondary hypothesis of the WISDOM trial is that lower dose-intensity is superior to current standard guideline-directed CRRT dose-intensity for critically ill patients with AKI with respect to duration of CRRT and successful liberation from RRT and kidney recovery
Justification No randomized controlled trial RCT to date has specifically evaluated the lower dose-intensity threshold for critically ill patients receiving CRRT Specifically there has been no specific evidence or guidance on the minimum dose-intensity targets for patients receiving CRRT This is important for several reasons First CRRT is an invasive resource intensive and expensive therapy As such there should be a concerted effort to minimize time on RRT and facilitate early recovery and weaning Second abundant evidence derived from secondary analyses have suggested that higher CRRT dose-intensity can propagate oliguria prolong CRRT therapy and delay kidney recovery This would imply that lower dose-intensity may facilitate kidney recovery and earlier weaning from CRRT Third there may be added implications of higher dose-intensity including prolongation of non-renal organ support such as delay in weaning from invasive mechanical ventilation Fourth evidence derived from observational registries show that lower CRRT dose-intensity in the range proposed in this trial provides comparable efficacy in azotemic metabolic and acid-base homeostasis with similar outcomes Observational data have suggested a prescribed CRRT dose-intensity of 15 mLkghr may be sufficient for metabolic and azotemic control and is not associated with worse outcomes compared with guideline directed dose-intensity This is lower quality evidence however implies that lower dose-intensity may be acceptable and safe Fifth it is plausible that following a short period of metabolic stabilization with CRRT the minimum recommended CRRT dose-intensity of 20-25 mLkghr may be excessive and have unmeasurable harm eg excessive clearance of electrolytes micronutrients and medications antimicrobials Finally the prescription of a lower CRRT dose-intensity may have meaningful impact on reducing bedside nursing workload eg fewer replacement solution bag changes and reducing costs attributable to CRRT eg lower effluent rates will reduce total replacement solution utilized
While this proposal outlines a pilot feasibility trial it is aimed at performing a larger rigorous RCT that will generate generalizable and high-quality evidence to impact clinical practice The findings of the main phase of the WISDOM trial will provide clearer evidence to guide the prescription of a minimal dose-intensity for patients receiving CRRT While this may be an effluent dose of 20-25 mLkghr it is entirely plausible that this will be a lower dose-intensity
Objectives The overall WISDOM trial program will address whether a lower CRRT dose-intensity in critically ill patients with AKI is non-inferior to standard CRRT dose-intensity and will secondarily address whether lower CRRT dose intensity will shorten total CRRT duration and improve kidney recovery compared with standard CRRT dose-intensity
Hypothesis The primary hypothesis of the WISDOM trial is that lower CRRT dose-intensity is non-inferior to current standard guideline-directed CRRT dose-intensity for critically ill patients with AKI with respect to duration of CRRT and successful liberation from RRT and kidney recovery The secondary hypothesis of the WISDOM trial is that lower dose-intensity is superior to current standard guideline-directed CRRT dose-intensity for critically ill patients with AKI with respect to duration of CRRT and successful liberation from RRT and kidney recovery
Justification No randomized controlled trial RCT to date has specifically evaluated the lower dose-intensity threshold for critically ill patients receiving CRRT Specifically there has been no specific evidence or guidance on the minimum dose-intensity targets for patients receiving CRRT This is important for several reasons First CRRT is an invasive resource intensive and expensive therapy As such there should be a concerted effort to minimize time on RRT and facilitate early recovery and weaning Second abundant evidence derived from secondary analyses have suggested that higher CRRT dose-intensity can propagate oliguria prolong CRRT therapy and delay kidney recovery This would imply that lower dose-intensity may facilitate kidney recovery and earlier weaning from CRRT Third there may be added implications of higher dose-intensity including prolongation of non-renal organ support such as delay in weaning from invasive mechanical ventilation Fourth evidence derived from observational registries show that lower CRRT dose-intensity in the range proposed in this trial provides comparable efficacy in azotemic metabolic and acid-base homeostasis with similar outcomes Observational data have suggested a prescribed CRRT dose-intensity of 15 mLkghr may be sufficient for metabolic and azotemic control and is not associated with worse outcomes compared with guideline directed dose-intensity This is lower quality evidence however implies that lower dose-intensity may be acceptable and safe Fifth it is plausible that following a short period of metabolic stabilization with CRRT the minimum recommended CRRT dose-intensity of 20-25 mLkghr may be excessive and have unmeasurable harm eg excessive clearance of electrolytes micronutrients and medications antimicrobials Finally the prescription of a lower CRRT dose-intensity may have meaningful impact on reducing bedside nursing workload eg fewer replacement solution bag changes and reducing costs attributable to CRRT eg lower effluent rates will reduce total replacement solution utilized
While this proposal outlines a pilot feasibility trial it is aimed at performing a larger rigorous RCT that will generate generalizable and high-quality evidence to impact clinical practice The findings of the main phase of the WISDOM trial will provide clearer evidence to guide the prescription of a minimal dose-intensity for patients receiving CRRT While this may be an effluent dose of 20-25 mLkghr it is entirely plausible that this will be a lower dose-intensity
Objectives The overall WISDOM trial program will address whether a lower CRRT dose-intensity in critically ill patients with AKI is non-inferior to standard CRRT dose-intensity and will secondarily address whether lower CRRT dose intensity will shorten total CRRT duration and improve kidney recovery compared with standard CRRT dose-intensity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None