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Continuous Venovenous Hemofiltration Versus Continuous Venovenuous Hemodialysis

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ClinicalTrials.gov Identifier: NCT01062984
Recruitment Status : Active, not recruiting
First Posted : February 4, 2010
Last Update Posted : October 26, 2016
Sponsor:
Collaborator:
NxStage Medical
Information provided by (Responsible Party):
University of Chicago

Brief 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.).


Condition or disease Intervention/treatment Phase
Acute Renal Failure Procedure: Continuous Venovenous Hemofiltration (CVVH) Procedure: Continuous Venovenous Hemodialysis (CVVHD) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2009
Actual Primary Completion Date : September 2015
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. To compare the clearance of urea and creatinine by RRT using continuous venovenous hemofiltration versus continuous venovenous hemodialysis. [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062984


Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
NxStage Medical
Investigators
Principal Investigator: Jay Koyner, MD University of Chicago

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01062984     History of Changes
Other Study ID Numbers: IRB# 15947A
First Posted: February 4, 2010    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by University of Chicago:
Renal Replacement Therapy

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