Overview

This trial is active, not recruiting.

Condition acute renal failure
Treatments continuous venovenous hemofiltration (cvvh), continuous venovenous hemodialysis (cvvhd)
Sponsor University of Chicago
Collaborator NxStage Medical
Start date January 2009
End date September 2015
Trial size 20 participants
Trial identifier NCT01062984, IRB# 15947A

Summary

Acute kidney injury is often treated with the use of continuous renal replacement therapy. Two commonly used treatments are continuous venvenous hemofiltration (CVVH)and continuous venovenous hemodialysis (CVVHD). CVVH uses convective clearance to remove toxins and solutes from the patients circulation, while CVVHD relies on diffusive clearance to remove these same toxins/solutes. This study will evaluate which of these two methods is more effective at clearing the body of waste/solutes.

We hypothesize that renal replacement therapy by either modality (hemodialysis or hemofiltration; CVVHD or CVVH, respectively) using a modern membrane and higher blood flow rates will be associated with similar clearances of both small and middle molecular weight solutes. We further believe that continuous renal replacement therapy using CVVHD will be associated with decreased clotting events and longer hemofilter survival, as well as improved resource utilization (i.e. nursing time, alarms, etc.).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
continuous venovenous hemofiltration (cvvh)
The NxStage system will be used for CVVH using the NxStage Cartridge Express dialyzer (polyethersulfone membrane). The blood flow rate will be set at 250 cc/min, and decreased at the discretion of the primary nephrologist's assessment of filter pressures and alarms. Replacement fluid will be delivered pre-filter for CVVHthe target effluent flow rate will be 35ml/kg/hr plus desired ultrafiltration (fluid removal). A maximum of 4.5 L/hr effluent will be prescribed to obese or hypercatabolic patients.
(Active Comparator)
continuous venovenous hemodialysis (cvvhd)
The NxStage system will be used for CVVH and CVVHD using the NxStage Cartridge Express dialyzer (polyethersulfone membrane). The blood flow rate will be set at 250 cc/min, and decreased at the discretion of the primary nephrologist's assessment of filter pressures and alarms. Replacement fluid dialysate will be infused countercurrent to blood flow the target effluent flow rate will be 35ml/kg/hr plus desired ultrafiltration (fluid removal). A maximum of 4.5 L/hr effluent will be prescribed to obese or hypercatabolic patients.

Primary Outcomes

Measure
To compare the clearance of urea and creatinine by RRT using continuous venovenous hemofiltration versus continuous venovenous hemodialysis.
time frame: 48 hours

Secondary Outcomes

Measure
To compare the clearance cystatin C and inflammatory cytokines (IL-6 and IL-10) by RRT using continuous venovenous hemofiltration versus continuous venovenous hemodialysis.
time frame: 48 hours

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age 18 or older and able to sign consent (or surrogate). - Must have been referred to the inpatient Nephrology consult service for evaluation of AKI. - Expected survival of at least 48 hours. Exclusion Criteria: - Hemoglobin < 8 g/dl - Serum potassium ≥6.5mEq/L - Weight > 120kg.

Additional Information

Official title A Comparison of the Efficacy of Continuous Venovenous Hemofiltration Versus Continuous Venovenous Hemodialysis for Renal Replacement Therapy in Acute Kidney Injury
Principal investigator Jay Koyner, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University of Chicago.