Continuous Venovenous Hemofiltration Versus Continuous Venovenuous Hemodialysis
This study is currently recruiting participants.
Verified June 2012 by University of Chicago
Sponsor:
University of Chicago
Collaborator:
NxStage Medical
Information provided by (Responsible Party):
Jay Koyner, University of Chicago
ClinicalTrials.gov Identifier:
NCT01062984
First received: February 3, 2010
Last updated: June 12, 2012
Last verified: June 2012
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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: | February 2013 |
| Estimated Primary Completion Date: | September 2012 (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
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: | Jay Koyner, Assistant Professor of Medicine, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT01062984 History of Changes |
| Other Study ID Numbers: | IRB# 15947A |
| Study First Received: | February 3, 2010 |
| Last Updated: | June 12, 2012 |
| 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 May 19, 2013