Continuous Venovenous Hemofiltration Versus Continuous Venovenuous Hemodialysis

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Chicago
Sponsor:
Collaborator:
NxStage Medical
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01062984
First received: February 3, 2010
Last updated: September 6, 2013
Last verified: June 2013
  Purpose

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.).


Condition Intervention
Acute Renal Failure
Procedure: Continuous Venovenous Hemofiltration (CVVH)
Procedure: Continuous Venovenous Hemodialysis (CVVHD)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of the Efficacy of Continuous Venovenous Hemofiltration Versus Continuous Venovenous Hemodialysis for Renal Replacement Therapy in Acute Kidney Injury

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • To compare the clearance of urea and creatinine by RRT using continuous venovenous hemofiltration versus continuous venovenous hemodialysis. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2009
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Continuous Venovenous Hemofiltration Procedure: 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 Venovenouos Hemodialysis Procedure: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062984

Contacts
Contact: Jay Koyner, MD 773-702-4842 jkoyner@medicine.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Jay Koyner, MD    773-702-4842      
Principal Investigator: Jay Koyner, MD         
Sponsors and Collaborators
University of Chicago
NxStage Medical
Investigators
Principal Investigator: Jay Koyner, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01062984     History of Changes
Other Study ID Numbers: IRB# 15947A
Study First Received: February 3, 2010
Last Updated: September 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Renal Replacement Therapy

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 19, 2014