Continuous Venovenous Hemofiltration Versus Continuous Venovenuous Hemodialysis
Primary Purpose
Acute Renal Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Venovenous Hemofiltration (CVVH)
Continuous Venovenous Hemodialysis (CVVHD)
Sponsored by
About this trial
This is an interventional treatment trial for Acute Renal Failure focused on measuring Renal Replacement Therapy
Eligibility 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 acute kidney injury (AKI).
- Expected survival of at least 48 hours.
Exclusion Criteria:
- Hemoglobin < 8 g/dl
- Serum potassium ≥6.5 milliequivalents per liter (mEq/L)
- Weight > 120kg.
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Continuous Venovenous Hemofiltration
Continuous Venovenouos Hemodialysis
Arm Description
Outcomes
Primary Outcome Measures
To compare the clearance of urea and creatinine by renal replacement therapy (RRT) using continuous venovenous hemofiltration versus continuous venovenous hemodialysis.
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.
Full Information
NCT ID
NCT01062984
First Posted
February 3, 2010
Last Updated
May 8, 2023
Sponsor
University of Chicago
Collaborators
NxStage Medical
1. Study Identification
Unique Protocol Identification Number
NCT01062984
Brief Title
Continuous Venovenous Hemofiltration Versus Continuous Venovenuous Hemodialysis
Official Title
A Comparison of the Efficacy of Continuous Venovenous Hemofiltration Versus Continuous Venovenous Hemodialysis for Renal Replacement Therapy in Acute Kidney Injury
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
October 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
NxStage Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Renal Failure
Keywords
Renal Replacement Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuous Venovenous Hemofiltration
Arm Type
Active Comparator
Arm Title
Continuous Venovenouos Hemodialysis
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Continuous Venovenous Hemofiltration (CVVH)
Intervention Description
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 CVVH; 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.
Intervention Type
Procedure
Intervention Name(s)
Continuous Venovenous Hemodialysis (CVVHD)
Intervention Description
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 Measure Information:
Title
To compare the clearance of urea and creatinine by renal replacement therapy (RRT) using continuous venovenous hemofiltration versus continuous venovenous hemodialysis.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 acute kidney injury (AKI).
Expected survival of at least 48 hours.
Exclusion Criteria:
Hemoglobin < 8 g/dl
Serum potassium ≥6.5 milliequivalents per liter (mEq/L)
Weight > 120kg.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Koyner, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34519356
Citation
Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.
Results Reference
derived
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Continuous Venovenous Hemofiltration Versus Continuous Venovenuous Hemodialysis
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