NCT01062984

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.).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2010

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
7.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2022

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

6.7 years

First QC Date

February 3, 2010

Last Update Submit

May 8, 2023

Conditions

Keywords

Renal Replacement Therapy

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (2)

Continuous Venovenous Hemofiltration

ACTIVE COMPARATOR
Procedure: Continuous Venovenous Hemofiltration (CVVH)

Continuous Venovenouos Hemodialysis

ACTIVE COMPARATOR
Procedure: Continuous Venovenous Hemodialysis (CVVHD)

Interventions

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 Hemofiltration

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.

Continuous Venovenouos Hemodialysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Hemoglobin \< 8 g/dl
  • Serum potassium ≥6.5 milliequivalents per liter (mEq/L)
  • Weight \> 120kg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Continuous Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Jay Koyner, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2010

First Posted

February 4, 2010

Study Start

January 1, 2009

Primary Completion

September 1, 2015

Study Completion

October 25, 2022

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations