Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369064
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-12
Brief Title:
Continuous Veno-venous Hemodialysis and Continuous Veno-venous Hemodiafiltration on Urea Reduction Rate in Intensive Care Patient
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Centre Hospitalier Universitaire de Nīmes
Study Overview
Official Title:
Comparison of the Effectiveness of Continuous Veno-venous Hemodialysis and Continuous Veno-venous Hemodiafiltration on Urea Reduction Rate in Intensive Care Patients With Acute Renal Injury a Monocentric Controled Randomized Non Inferiority Open Labeled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
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:
CompEER
Brief Summary:
In patients requiring renal replacement therapy RRT in the intensive care unit ICU continuous techniques are predominantly using due to better hemodynamic tolerance The most employed techniques in ICU are continuous venovenous hemodiafiltration CVVHDF and continuous venovenous hemodialysis CVVHD
To our knowledge there are no prospective studies comparing the efficiency of these two techniques with the same dose of dialysis and the same filter
In the CompEER study we aim to compare the efficiency of CVVHD and CVVHDF on urea reduction rate in intensive care patients with acute kidney injury
The research hypothesis is that CVVHD citrate technique is as effective as CVVHDF heparin technique for urea reduction and provides prolonged and stable clearance facilitating antibiotic management during RRT
To our knowledge there are no prospective studies comparing the efficiency of these two techniques with the same dose of dialysis and the same filter
In the CompEER study we aim to compare the efficiency of CVVHD and CVVHDF on urea reduction rate in intensive care patients with acute kidney injury
The research hypothesis is that CVVHD citrate technique is as effective as CVVHDF heparin technique for urea reduction and provides prolonged and stable clearance facilitating antibiotic management during RRT
Detailed Description:
Acute Kidney Injury AKI is found in more than 50 of intensive care unit ICU patients with 30 classified as AKI Network AKIN stage 3 Approximately 23 of AKI patients undergo RRT predominantly utilizing continuous techniques due to better hemodynamic tolerance in unstable patients Common continuous RRT techniques include continuous venovenous hemofiltration CVVH continuous venovenous hemodialysis CVVHD and continuous venovenous hemodiafiltration CVVHDF
The two most employed techniques in ICU are CVVHDF and CVVHD However the choice often depends on institutional practices rather than scientific evidence Limited studies comparing these techniques at equivalent doses exist and French recommendations allow intensivists discretion based on availability and team experience A small randomized study comparing different exchange rates found higher urea reduction in CVVHDF but lacked statistical significance Current practices in ICU involve using CVVHDF with systemic anticoagulation or CVVHD with regional citrate anticoagulation based on practitioner preferences
Despite potential benefits of CVVHD with citrate such as extended filter lifespan and stable dialysis dose the impact on concomitant treatments especially antibiotics needs consideration
The study aims to demonstrate the non-inferiority of citrate-based continuous hemodialysis CVVHD compared to heparin-based continuous hemodiafiltration CVVHDF in terms of urea reduction rate at 24 hours in AKI patients requiring renal replacement therapy
The hypothesis is that CVVHD citrate is as effective as CVVHDF heparin providing prolonged and stable clearance facilitating antibiotic management during RRT
The two most employed techniques in ICU are CVVHDF and CVVHD However the choice often depends on institutional practices rather than scientific evidence Limited studies comparing these techniques at equivalent doses exist and French recommendations allow intensivists discretion based on availability and team experience A small randomized study comparing different exchange rates found higher urea reduction in CVVHDF but lacked statistical significance Current practices in ICU involve using CVVHDF with systemic anticoagulation or CVVHD with regional citrate anticoagulation based on practitioner preferences
Despite potential benefits of CVVHD with citrate such as extended filter lifespan and stable dialysis dose the impact on concomitant treatments especially antibiotics needs consideration
The study aims to demonstrate the non-inferiority of citrate-based continuous hemodialysis CVVHD compared to heparin-based continuous hemodiafiltration CVVHDF in terms of urea reduction rate at 24 hours in AKI patients requiring renal replacement therapy
The hypothesis is that CVVHD citrate is as effective as CVVHDF heparin providing prolonged and stable clearance facilitating antibiotic management during RRT
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