Continuous Venovenous Hemofiltration Versus Continuous Venovenuous Hemodialysis

Sponsor
University of Chicago (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01062984
Collaborator
NxStage Medical (Other)
20
1
2
159.9
0.1

Study Details

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.).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Continuous Venovenous Hemofiltration (CVVH)
  • Procedure: Continuous Venovenous Hemodialysis (CVVHD)
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2009
Actual Primary Completion Date :
Sep 1, 2015
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

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 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.

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.

Outcome Measures

Primary Outcome Measures

  1. To compare the clearance of urea and creatinine by renal replacement therapy (RRT) using continuous venovenous hemofiltration versus continuous venovenous hemodialysis. [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. [48 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Chicago
ClinicalTrials.gov Identifier:
NCT01062984
Other Study ID Numbers:
  • IRB# 15947A
First Posted:
Feb 4, 2010
Last Update Posted:
Apr 28, 2021
Last Verified:
Apr 1, 2021
Keywords provided by University of Chicago
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2021