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| Sponsors and Collaborators: |
St. Michael's Hospital, Toronto University of Toronto |
|---|---|
| Information provided by: | St. Michael's Hospital, Toronto |
| ClinicalTrials.gov Identifier: | NCT00675818 |
Purpose
Acute kidney injury (AKI) in the intensive care unit is common, devastating and costly. However, minimal evidence exists to guide the prescription of optimal renal replacement therapy (RRT). An important area of uncertainty surrounds the relative effects of convective versus diffusive modes of clearance. Although both clearance modes provide similar degrees of small molecule clearance, convective modes permit the enhanced clearance of larger-sized molecules which may mediate kidney and systemic toxicity in the setting of AKI.
Continuous renal replacement therapies (CRRTs) are frequently applied in critically ill patients with AKI. Convective clearance, as applied through continuous venovenous hemofiltration (CVVH) and diffusive clearance, as applied through continuous venovenous hemodialysis (CVVHD), may be readily compared in the context of patients receiving CRRT.
The purpose of this study is to examine the feasibility of conducting a larger study that will determine whether convective clearance (hemofiltration) confers improved outcomes as compared to diffusive clearance (hemodialysis) in patients with AKI.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Kidney Injury |
Device: Continuous venvenous hemofiltration (CVVH) Device: Continuous venovenous hemodialysis (CVVHD) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
| Official Title: | The Optimal Mode of Renal Replacement Therapy in Acute Kidney Injury (OMAKI) Study: A Pilot Randomized Controlled Trial of Convective Versus Diffusive Clearance |
| Estimated Enrollment: | 75 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
CVVH: Patients in this arm will receive CVVH at a replacement fluid rate of 35 mL/kg/h.
|
Device: Continuous venvenous hemofiltration (CVVH)
Continuous venovenous hemofiltration with a replacement fluid rate of 35 mL/kg/hr.
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2: Active Comparator
CVVHD: Patients in this arm will receive CVVHD at a dialysate flow rate of 35 mL/kg/h.
|
Device: Continuous venovenous hemodialysis (CVVHD)
Continuous venovenous hemodialysis at a dialysate flow rate of 35 mL/kg/hr.
|
The optimal mode of clearance in critically ill patients with acute kidney injury (AKI) who require renal replacement therapy (RRT) is unclear. Although both convection (as provided by hemofiltration) and diffusion (as provided by hemodialysis) provide equivalent removal of small-sized molecules, hemofiltration offers the potential for removal of large molecules many of which may be toxic. Hemofiltration and hemodialysis have never been compared in a rigorous randomized trial to date.
Continuous renal replacement therapies (CRRT) are widely used in the management of critically ill patients with AKI and current CRRT technology provides a practical platform on which to compare convective and diffusive clearance. We hypothesize that continuous venovenous hemofiltration (CVVH)- at identical doses of small molecule clearance that are provided by the comparison treatment of continuous venovenous hemodialysis (CVVHD)- leads to improved patient outcomes.
This study is an unblinded pilot RCT designed to test the feasibility of conducting a subsequent large scale study that will assess whether CVVH leads to improved patient outcomes (ie, survival, renal recovery) as compared to CVVHD. Although we will be collecting the full array of patient-relevant data for up to 60 days following randomization, the main purpose of this pilot study is to demonstrate the feasibility of recruiting, treating and following patients for a study designed to test this hypothesis.
Patient Population
The recruitment target for this study is 75 patients (25/site x 3 sites).
The inclusion and exclusion criteria are designed to enroll patients with AKI on the basis of presumed acute tubular necrosis who would ordinarily be candidates for continuous renal replacement therapies (CRRT) in Canada. The overall philosophy is to enroll and begin applying the study therapy as close as possible to the clinical need to start renal replacement therapy. Similarly, we would like to avoid enrolling patients whose risk of death is so high that the study therapy is unlikely to impact on the clinical outcome.
Treatments
We will employ equivalent doses of hemofiltration (35 mL/kg/hr of replacement fluid) and hemodialysis (35 mL/kg/hr of dialysate). This dose was chosen on the basis of an emerging body of evidence suggesting improved outcomes when compared to a dose of 20 mL/kg/hr.
Therapies will be administered using Primsaflex machines (Gambro Inc.) using regional citrate anticoagulation. Hospital-specific protocols for the administration of regional citrate anticoagulation will be used. We have obtained Health Canada permission to utilize Prismocal (currently approved as a dialysate) as an infusate in patients receiving CVVH.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Attending physician deems the patient a candidate for RRT for at least one of the following reasons:
Exclusion Criteria:
Contacts and Locations| Canada, Ontario | |
| St. Michael's Hospital | Recruiting |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Contact: Ron Wald, MDCM 416-867-3703 waldr@smh.toronto.on.ca | |
| Contact: Jan O Friedrich, MD 416-864-6060 ext 3197 friedrichj@smh.toronto.on.ca | |
| Principal Investigator: Ron Wald, MDCM, MPH | |
| Sub-Investigator: Jan O Friedrich, MD MSc DPhil | |
| Sub-Investigator: Karen Burns, MD MSc | |
| Mt. Sinai Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 1X5 | |
| Contact: Stephen Lapinsky, MD slapinsky@mtsinai.on.ca | |
| Contact: Robert MA Richardson, MD robert.richardson@uhn.on.ca | |
| Principal Investigator: Stephen Lapinsky, MD | |
| Sub-Investigator: Robert MA Richardson, MD | |
| Sunnybrook Health Sciences Centre | Recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Contact: Neill Adhikari, MDCM neill.adhikari@sunnybrook.ca | |
| Contact: Michelle Hladunewich, MD MSc michelle.hladunewich@sunnybrook.ca | |
| Principal Investigator: Neill Adhikari, MDCM MSc | |
| Sub-Investigator: Michelle Hladunewich, MD MSc | |
| Principal Investigator: | Ron Wald, MDCM | St. Michael's Hospital and University of Toronto |
More Information
| Responsible Party: | St. Michael's Hospital and University of Toronto ( Ron Wald, MDCM MPH ) |
| Study ID Numbers: | 07097 |
| Study First Received: | May 7, 2008 |
| Last Updated: | November 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00675818 History of Changes |
| Health Authority: | Canada: Institutional Review Board |
|
acute kidney injury renal replacement therapy critical care unit hemodialysis hemofiltration |
