Renal Replacement Therapy in Critical Care

• Policy Forum Options Series
• Issue
• Key Research Findings from CADTH HTA
• Background
• Policy Issue
• Key Stakeholders
• Current Implementation Status
• Findings
• Budgetary Savings Calculator
• Key Implementation Considerations

The Policy Forum is a pan-Canadian committee of senior health care decision-makers who are tasked with the development of evidence-based joint policy initiatives related to the implementation, management, and decommissioning of health technologies. The Policy Forum was created in response to the Health Technology Strategy 1.0, and its subsequent implementation strategy, approved by the Conference of Deputy Ministers in May 2004 and April 2005 respectively. Members of the Policy Forum include senior officials involved in health policy from each of the 14 federal, provincial and territorial health ministries, as appointed by the Deputy Ministers of Health. Also included are two non-voting members: one from Industry Canada and the other from the Interprovincial and Territorial Medical Directors group. The Canadian Agency for Drugs and Technologies in Health (CADTH) serves as the secretariat for the Policy Forum.

This is the first options paper produced by the Policy Forum and it has served to test the process for the development of joint health technology policy initiatives. The analysis presented in this document is based primarily on evidence from a health technology assessment (HTA) produced by CADTH.[1]   An expert review panel was struck to obtain input from nephrologists, intensivists, and program managers from across the country.

The intended audience for this options document includes decision-makers at regional health authorities, renal program managers, critical care unit managers, and clinicians treating acute renal failure in critical care settings. The purpose of this document is to assist these individuals in making evidence-based decisions about the provision of renal replacement therapies in critical care settings. This document is not intended to serve as a clinical guideline.

To reduce hospital-based acute care spending while promoting positive clinical outcomes by determining which of the two most commonly used renal replacement therapies for acute renal failure in critically ill adult patients is most appropriate.

Table 1: Overview of Acute Renal Failure and Renal Replacement Therapy

Acute Renal Failure

• leads to build-up of toxins, excess salts and fluid in the body
• fatal if untreated
• occurs in 20% to 25% of patients admitted to intensive care units
• current incidence of acute renal failure requiring dialysis is estimated at 11 per 100,000 in the Canadian adult population per year or about 2,445 cases per year in Canada associated with high in-hospital mortality (40% to 65%) and health care costs

Renal Replacement Therapy

• removes toxins and fluid from the body through diffusion, convection, or a combination of interventions
• most patients can tolerate both IHD and CRRT
• some clinicians believe CRRT offers superior clinical outcomes, although there is a lack of evidence to demonstrate this belief.

Table 2: Overview of Renal Replacement Therapies in Critical Care Settings*

Characteristic

IHD

CRRT

Duration

• a few hours at variable intervals (for example, up to   4 hours, 3 to 4 times per week; some hybrid modalities are performed daily)

• performed continuously
  (24 hours per day)

Advantages

• low risk of systemic bleeding
• short duration facilitates patient mobility and/or availability for other procedures[2]

theoretical benefits include:

• increased total solute clearance over 24 hours
• better hemodynamic tolerance due to a slower rate of fluid removal
• enhanced removal of toxins, including solutes of large molecular weight (e.g., cytokines) that may contribute to adverse outcomes associated with critical illness.

 Disadvantages

• rapid, high-volume fluid removal may lead to hypotension[3]

• requires continuous anticoagulation (which might predispose patients to bleeding)
• involves continuous exposure to an extracorporeal circuit (which might lead to adverse consequences, including complement activation or infection)

Average Cost per Hospitalization^†

$2,103

$5,757

Total Potential Cost Savings

$2.1M to  $6.1M per year depending on actual rate of CRRT currently provided.

The present approach to management of acute renal failure in critically ill patients in Canada is inconsistent and depends upon the following factors: availability of equipment; costs; physician specialties, expertise, preference or management philosophy; indication for renal replacement (fluid removal versus solute clearance); availability of trained nursing staff; and unproven beliefs about the benefits of each therapy.

The key groups and individuals likely to be affected by this issue and proposed options include the following:

• Intensivists
• Nephrologists
• Dialysis nurses
• Critical care nurses
• Intensive Care Unit managers
• Renal Unit managers
• Renal program managers
• Administrators
• Canadian Association of Nephrology Nurses and Technologists
• Canadian Society of Nephrology
• Canadian Association of Critical Care Nurses
• Canadian Critical Care Trials Group.

• Presently, there is substantial regional variation in the management of acute renal failure among critically ill adults in Canada.
• There is similar variation internationally, and in some places, such as Australia, CRRT is the only dialysis modality used.
• Factors in the selection of dialytic modality may include availability, costs, physician expertise or preference, indication for renal replacement (fluid removal versus solute clearance), availability of trained nursing staff, and perceptions about the theoretical benefits of each therapy.
• There are no North American or European clinical practice guidelines that address the choice of dialytic modality in acute renal failure.
• Information on the availability and rate of use of CRRT by jurisdiction in Canada is not available.

Table 3: Policy Options

Consideration

Option 1: Status Quo

Option 2: Exclusive use of CRRT

Option 3: Exclusive use of IHD

To allow the provision IHD or CRRT to be determined on the basis of existing resources and/or provider preference. Based on a review of the literature, at centres where CRRT is available, it is currently being provided in 26% to 68% of acute renal failure cases in critically ill patients.

To provide CRRT exclusively when treating acute renal failure in critically ill patients, with IHD being made available only for rare exceptions. Many providers prefer CRRT as they believe it offers clinical advantages compared with IHD, although the current evidence suggests that this approach does not lead to statistically significant differences in patient outcomes such as the number of hospitalization days and dependence on dialysis. It has been demonstrated that CRRT is tolerated by patients equally as well as IHD.

To provide IHD exclusively when treating acute renal failure in critically ill patients, with CRRT available for rare exceptions. The cost of treatment with IHD is $3,654 less per patient than the cost of treatment with CRRT. In Canada, selective funding of IHD (i.e., a reduction in the use of CRRT to approximately 0% of cases) could potentially save $2.1 million to $6.1 million (assuming a current rate of use of 26% to 68%) in acute care costs per year, depending on the actual current CRRT rate of use.

Clinical Considerations

Potential Benefit to Patients or Overall Population Health

Current evidence suggests patient outcomes are the same whether treated with CRRT or IHD.

No evidence that IHD is better tolerated than CRRT.

No evidence that IHD leads to improved patient outcomes compared with CRRT.

No evidence that CRRT is better tolerated than IHD.

No evidence that CRRT leads to improved patient outcomes compared with IHD.

Impact on Quality of Life

n/a

n/a

n/a

Economic Considerations

Human Resources

Both critical care nurses and dialysis nurses are required for mixed model availability of therapies.

CRRT is usually performed by critical care nurses.

IHD is often performed by dialysis nurses (who don’t otherwise work in Intensive Care Units or in other critical care settings)

Estimated nursing costs of $149 per run.*

Equipment (including purchase price, maintenance costs, and consumables)

Depends upon the mix of CRRT and IHD provided.

The purchase price of the CRRT machine is approximately $36,000.

This machine cannot be used to provide IHD.

The purchase price of an IHD machine is approximately $28,000.

This machine can also be used to treat chronic kidney conditions.

Supplies and Replacement Fluid

Depends upon the mix of CRRT and IHD provided.

$416 per run*

$68.30 per run*

Total Cost per Patient (single hospitalization)

Depends upon the mix of CRRT and IHD provided.

$5,757

$2,103

Additional Considerations

Patient Preference and Convenience

Not a relevant consideration in the critical care environment.

Not a relevant consideration in the critical care environment.

Not a relevant consideration in the critical care environment.

Psychosocial Issues

n/a

n/a

n/a

Public Opinion and Consumer Demand

n/a

n/a

n/a

Legal Considerations

n/a

n/a

n/a

Ethical Issues

n/a

n/a

n/a

Implementation Issues

n/a

n/a

Some clinicians strongly believe that CRRT is superior to IHD and they may, therefore, be resistant to using IHD.

Other

Depends upon the mix of CRRT and IHD provided.

CRRT is often prescribed when no nephrologists are available.

CRRT can be used pre-emptively to prevent kidney injury.

When demand in the critical care setting is low, equipment and human resources for IHD can be used elsewhere to treat patients with chronic kidney conditions.
Sunken costs of equipment purchased for CRRT (which cannot be used for anything else) would be lost with exclusive use of IHD.

Based on the above analysis, it is recommended that option 3 be followed. That is, IHD should be provided exclusively for hemodynamically stable patients in the critical care setting. Adherence to this option will result in the provision of cost-effective treatment without compromising patient outcomes.

Exceptions to this policy could be made for patients having previously failed this treatment or for those in whom IHD is otherwise contraindicated.

Any further allocation of equipment or staff for the provision of CRRT in the critical care setting should be adjusted to the amount required for treatment of patients with contraindications to IHD only, until or unless there is evidence to demonstrate that this modality offers superior clinical outcomes.

Time frame for Review

The Policy Forum will re-examine the available evidence on this topic and review the recommendation in five-years (2013), or earlier, if prompted by specific evidence or circumstances.

_______________

For those centres currently providing CRRT, there are a number of factors that must be considered in determining whether and how to transition to a policy of exclusive provision of IHD. First, there are sunken costs. Many acute care centres already own the equipment required for CRRT and this equipment cannot be used in the provision of IHD. Second, CRRT is typically performed by critical care nurses while IHD is performed by dialysis nurses. Exclusive provision of IHD would require the purchase of additional dialysis equipment or the reallocation of dialysis equipment currently being used to treat patients with chronic kidney conditions, and human resources would need to be shuffled or retrained to administer IHD.

While it has yet to be demonstrated that patient outcomes resulting from treatment with IHD and CRRT are significantly different, wide confidence intervals suggest that further study could identify clinical benefit from CRRT. In future studies, if CRRT is shown to lead to improved patient outcomes, it may be demonstrated that these outcomes, such as reduced long-term dependence on dialysis, lead to decreased downstream health costs related to chronic kidney conditions. For this reason, as well as the need to treat patients with contraindications to IHD, it may be advantageous for centres to retain CRRT equipment and staff with skill sets to operate it.

Local Barriers

When implementing this recommendation, each decision-maker must take into consideration unique local circumstances. The following factors have been identified as potential barriers to implementation of the recommendation at the local level:

• Existing mix of equipment for CRRT and IHD
• Availability of nurses qualified to provide IHD in the critical care setting
• Existing practice patterns of clinicians

          Availability and/or accessibility of nephrologists available for consultation.

Other Factors

When considering the adoption, management, or decommissioning of a health technology, the following questions should be considered:

• Of those served by your organization, what is the size of the population that currently benefits or will potentially benefit from this technology?
• What is the current diffusion of this technology?
• Does the technology require building renovations or acquisitions?
• Does the technology require dedicated human resources or specialized training?
• Will adoption, change in management, or decommissioning of the technology have an effect on other services?
• Are there ethical considerations or other risks?
• What will be the immediate cost of the technology and the cost during the long term, including supplies and maintenance?

How will the impact of adoption, change in management, or decommissioning of the technology be measured?