The Optimal Mode of Renal Replacement Therapy in Acute Kidney Injury (OMAKI) Study

NCT00675818 | Completed Phase 4 DMC

• 1 other identifier: 07097
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 5

Brief 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. 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.

Conditions

Acute Kidney Injury

Keywords

acute kidney injury; renal replacement therapy; critical care unit; hemodialysis; hemofiltration

Outcome Measures

Primary Outcomes (1)

• 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.

  60 days

Secondary Outcomes (1)

• Change in Sequential Organ Failure Assessment (SOFA) score.

  7 days

Study Arms (2)

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)

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)

Interventions

Continuous venvenous hemofiltration (CVVH) DEVICE

Continuous venovenous hemofiltration with a replacement fluid rate of 35 mL/kg/hr.

1

Continuous venovenous hemodialysis (CVVHD) DEVICE

Continuous venovenous hemodialysis at a dialysate flow rate of 35 mL/kg/hr.

2

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• refractory hyperkalemia (K \> 6.0 mmol/L)
• azotemia (BUN \> 50 mmol/L)
• suspected uremic organ involvement (pericarditis, encephalopathy, neuropathy or myopathy)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Unity Health Toronto: lead
• University of Toronto: collaborator

Study Sites (5)

University of Alberta

Edmonton, Alberta, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Mt. Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related Publications (3)

• 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.

  PMID: 36416787 DERIVED

• 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.

  PMID: 34519356 DERIVED

• Wald 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.

  PMID: 23095370 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Continuous Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Ron Wald, MDCM

  St. Michael's Hospital and University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician/Scientist

Study Record Dates

• First Submitted: May 7, 2008
• First Posted: May 12, 2008
• Study Start: May 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 12, 2012

Record last verified: 2012-03

Locations

CA (5)