Acute Kidney InjuryPhase 4OMAKINCT00675818
The Optimal Mode of Renal Replacement Therapy in Acute Kidney Injury (OMAKI) Study
A Phase 4 study testing Continuous venvenous hemofiltration (CVVH) and Continuous venovenous hemodialysis (CVVHD) in people with Acute Kidney Injury, run by Unity Health Toronto at 5 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Continuous venvenous hemofiltration (CVVH) and Continuous venovenous hemodialysis (CVVHD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 5 sitesCanada
- Study dates
- May 2008to Oct 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients (over 16 years of age) admitted to a participating ICU
- Serum creatinine increase of ≥ 50% from baseline
- Hemodynamic instability as defined by the cardiovascular component of the SOFA score of ≥ 1
- Attending physician deems the patient a candidate for RRT for at least one of the following reasons:
- Presence of oliguria, defined as a urine output of < 100 mL in the preceding 4 hours
- metabolic acidosis (HCO3- < 15 mmol/L and pH < 7.25)
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- refractory hyperkalemia (K > 6.0 mmol/L)
- azotemia (BUN > 50 mmol/L)
- suspected uremic organ involvement (pericarditis, encephalopathy, neuropathy or myopathy)
Who cannot join
- renal replacement therapy within the previous 2 months
- presence of renal obstruction
- receipt of a kidney transplant in the previous year
- diagnosis of rapidly progressive glomerulonephritis, vasculitis, or acute interstitial nephritis
- indication for intermittent hemodialysis, specifically severe hyperkalemia, dialyzable drug or toxin
- terminal illness with associated life expectancy less than 2 months
Show all 11Show fewer
- patients who are moribund
- prior enrollment in this study
- enrollment in a competing ICU interventional study
- no CRRT machine available
- acute renal replacement ongoing for > 36 hours
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
University of Alberta
Edmonton, Alberta
London Health Sciences Centre
London, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Mt. Sinai Hospital
Toronto, Ontario, M5G 1X5
About this study
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
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.
Read the detailed description
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.
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).
Therapies will be administered using Primsaflex machines (Gambro Inc.) using regional citrate anticoagulation, heparin anticoagulation or no anticoagulation. Hospital-specific protocols for anticoagulation will be used. We have obtained Health Canada permission to utilize Prismocal, Normocarb, Hemosol BO and Prismasol 4 as infusates in patients receiving CVVH.
- Conditions
- Acute Kidney Injury
- Being tested
- Continuous venvenous hemofiltration (CVVH), Continuous venovenous hemodialysis (CVVHD)
- Keywords
- acute kidney injury, renal replacement therapy, critical care unit, hemodialysis, hemofiltration
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous venvenous hemofiltration (CVVH)Device
Continuous venovenous hemofiltration with a replacement fluid rate of 35 mL/kg/hr.
Continuous venovenous hemodialysis (CVVHD)Device
Continuous venovenous hemodialysis at a dialysate flow rate of 35 mL/kg/hr.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CVVH: Patients in this arm will receive CVVH at a replacement fluid rate of 35 mL/kg/h. Receives: Device: Continuous venvenous hemofiltration (CVVH) |
| 2 | Active comparator | CVVHD: Patients in this arm will receive CVVHD at a dialysate flow rate of 35 mL/kg/h. Receives: Device: Continuous venovenous hemodialysis (CVVHD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
We will study the feasibility of recruiting ther target population, administering the study therapies according to pre-defined protocols and following patients for clinical endpoints.
Measured: 60 days
Secondary outcomes (1)
Change in Sequential Organ Failure Assessment (SOFA) score.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2008 (estimated)
- Study startMay 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Principal investigator, Ron Wald, Unity Health Toronto
- Investigators
- Ron Wald, MDCM, Principal investigator, St. Michael's Hospital and University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675818
- Sponsor's protocol ID
- 07097
- Acronym
- OMAKI
- Status last verified
- Mar 2012
- First submitted
- 7 May 2008
- Last updated
- 12 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.
PubMed 36416787Tsujimoto 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.
PubMed 34519356Wald R, Friedrich JO, Bagshaw SM, Burns KE, Garg AX, Hladunewich MA, House AA, Lapinsky S, Klein D, Pannu NI, Pope K, Richardson RM, Thorpe K, Adhikari NK. Optimal Mode of clearance in critically ill patients with Acute Kidney Injury (OMAKI)--a pilot randomized controlled trial of hemofiltration versus hemodialysis: a Canadian Critical Care Trials Group project. Crit Care. 2012 Oct 24;16(5):R205. doi: 10.1186/cc11835.
PubMed 23095370
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00675818
- Acronym / sponsor ID
- OMAKI / 07097
- Conditions
- Acute Kidney Injury
- Keywords
- acute kidney injury, renal replacement therapy, critical care unit, hemodialysis, hemofiltration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- May 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 12 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
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).
Therapies will be administered using Primsaflex machines (Gambro Inc.) using regional citrate anticoagulation, heparin anticoagulation or no anticoagulation. Hospital-specific protocols for anticoagulation will be used. We have obtained Health Canada permission to utilize Prismocal, Normocarb, Hemosol BO and Prismasol 4 as infusates in patients receiving CVVH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Continuous venvenous hemofiltration (CVVH)CVVH: Patients in this arm will receive CVVH at a replacement fluid rate of 35 mL/kg/h. |
| 2 | Active comparator | Device: Continuous venovenous hemodialysis (CVVHD)CVVHD: Patients in this arm will receive CVVHD at a dialysate flow rate of 35 mL/kg/h. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patients (over 16 years of age) admitted to a participating ICU
- Serum creatinine increase of ≥ 50% from baseline
- Hemodynamic instability as defined by the cardiovascular component of the SOFA score of ≥ 1
- Attending physician deems the patient a candidate for RRT for at least one of the following reasons:
Key exclusion criteria (11 listed)
- renal replacement therapy within the previous 2 months
- presence of renal obstruction
- receipt of a kidney transplant in the previous year
- diagnosis of rapidly progressive glomerulonephritis, vasculitis, or acute interstitial nephritis
- indication for intermittent hemodialysis, specifically severe hyperkalemia, dialyzable drug or toxin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous venvenous hemofiltration (CVVH)Continuous venovenous hemofiltration with a replacement fluid rate of 35 mL/kg/hr. | Device | 1 |
| Continuous venovenous hemodialysis (CVVHD)Continuous venovenous hemodialysis at a dialysate flow rate of 35 mL/kg/hr. | Device | 2 |
Primary outcome
We will study the feasibility of recruiting ther target population, administering the study therapies according to pre-defined protocols and following patients for clinical endpoints.
Time frame: 60 days
1 secondary outcome
Change in Sequential Organ Failure Assessment (SOFA) score.
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2012.
- Derived from this study: PubMed 36416787Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.
- Derived from this study: PubMed 34519356Tsujimoto 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.
- Derived from this study: PubMed 23095370Wald R, Friedrich JO, Bagshaw SM, Burns KE, Garg AX, Hladunewich MA, House AA, Lapinsky S, Klein D, Pannu NI, Pope K, Richardson RM, Thorpe K, Adhikari NK. Optimal Mode of clearance in critically ill patients with Acute Kidney Injury (OMAKI)--a pilot randomized controlled trial of hemofiltration versus hemodialysis: a Canadian Critical Care Trials Group project. Crit Care. 2012 Oct 24;16(5):R205. doi: 10.1186/cc11835.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Wald, MDCM principal investigator
St. Michael's Hospital and University of Toronto
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Continuous venvenous hemofiltration (CVVH) and Continuous venovenous hemodialysis (CVVHD) in people with Acute Kidney Injury, run by Unity Health Toronto at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
We will study the feasibility of recruiting ther target population, administering the study therapies according to pre-defined protocols and following patients for clinical endpoints. (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00675818, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2012.