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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01062984
Other study ID # IRB# 15947A
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2009
Est. completion date October 25, 2022

Study information

Verified date May 2023
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.).


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date October 25, 2022
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States University of Chicago Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Chicago NxStage Medical

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To compare the clearance of urea and creatinine by renal replacement therapy (RRT) using continuous venovenous hemofiltration versus continuous venovenous hemodialysis. 48 hours
Secondary 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
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