NCT00561431

High Dose CVVHDF Compared to Standard Dose CVVHDF

A Randomized Prospective Study Comparing High Dose Continuous Venovenous Hemodiafiltration (CVVHDF) to Standard Dose CVVHDF in Critically Ill Patients With Acute Renal Failure at the University of Alabama at Birmingham

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

In the last three decades, the mortality associated with acute renal failure (ARF) in the ICU has remained unchanged at greater than 50%, despite improvements in dialysis technology. The primary objective is to determine whether Continuous Veno-Venous Hemodiafiltration (CVVHDF) using an ultrafiltration rate of 35 ml/hr/kg (high dose) leads to a greater reduction in all-cause ICU mortality compared to standard CVVHDF using an ultrafiltration rate of 20 ml/hr/kg.

Detailed description

Although the worldwide standard for renal replacement therapy is intermittent hemodialysis(IHD), continuous renal replacement therapy (CRRT) has emerged as an alternative form of renal replacement therapy in the critical care setting due to its advantages of slow continuous fluid removal, steady acid-base correction, and hemodynamic stability. There are no standard protocols for initiating or administering CRRT, and practice patterns vary widely among institutions, with less than 25% of patients with ARF in the ICU receiving this therapy in the United States. Various CRRT modalities are available that use diffusion, convection, or a combination of both to obtain adequate solute clearance. However, there is no consensus as to the optimal dialysis modality, adequate dialysis dose, or optimal clearance modality (convection vs. diffusion). Clinical trials are needed to determine the optimal method of administering CRRT, with respect to modality, dose of dialysis, and time of initiation of therapy. Although some studies suggest that a higher dose of dialysis improves survival, there have been no prospective randomized studies comparing the effectiveness of diffusion and convection, combined together, for solute clearance.

Conditions

• Acute Renal Failure

Interventions

Type	Name	Description
DEVICE	Standard dose of dialysis	Continuous Venovenous Hemodiafiltration (CVVHDF) effluent dose of 20 ml/kg/hr
DEVICE	High dose of dialysis	Continuous Venovenous Hemodiafiltration (CVVHDF) effluent rate 35 ml/kg/hr

Timeline

• Start date: 2003-07-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2007-11-21
• Last updated: 2015-04-14
• Results posted: 2010-03-12

Locations

1 site across 1 country: United States