Achieve. Achieve. More Effective. Dialysis Treatment

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1 Achieve More Effective Achieve Dialysis Treatment

lab-equivalent, non-invasive oxygen saturation Gold Standard Accuracy The Crit-Line monitor

2 The Crit-Line monitor measures the following: Real-time, lab-equivalent, non-invasive hematocrit (HCT) Real-time percent changes in intravascular blood volume Real-time, lab-equivalent, non-invasive oxygen saturation Gold Standard Accuracy The Crit-Line monitor hematocrit measurements are: Lab accurate Real-time (allows for immediate interventions) Continuous Non-invasive

Providing a Window into Your Patient s Bloodstream The Crit-Line monitor continuously measures a lab-equivalent hematocrit during a hemodialysis treatment without any blood sampling.

% BV CHANGE 0-5 -10-15 -20-25 HCT = RCV BV x100 0 1 2 3 4 TIME (Hours) 34 32 30 28 26 HCT By measuring the change in hematocrit during a treatment, the Crit-Line monitor is able to measure the

3 Providing a Window into Your Patient s Bloodstream The Crit-Line monitor continuously measures a lab-equivalent hematocrit during a hemodialysis treatment without any blood sampling. BV Profile Screen Inverse Relationship Between Hematocrit and Percent Blood Volume Change These graphs are hypothetical and may not be representative of actual treatments. % BV CHANGE HCT = RCV BV x TIME (Hours) HCT By measuring the change in hematocrit during a treatment, the Crit-Line monitor is able to measure the percent change in a patient s intravascular blood volume. As HCT increases due to ultrafiltration, the blood volume decreases. As ultrafiltration progresses, blood volume decreases and HCT increases. Additional Crit-Line monitor benefits: Removes the maximum amount of fluid while preventing common symptoms of dialysis (e.g. nausea, cramping, vomiting). Provides a more effective treatment process for dialysis patients and clinicians. Peer-reviewed studies explain how the Crit-Line monitor has been used: The Controversies of Diagnosing and Treating Hypertension Among Hemodialysis Patients Rajiv Agarwal. Seminars in Dialysis. 25:4 pp July 2012 Hypervolemia Is Associated With Increased Mortality Among Hemodialysis Patients Rajiv Agarwal. Hypertension. 56:3 pp September 2010

Introduction of Dynamics in the Body Three Compartment Model Intracellular Interstitial Circulating Blood Volume Intra-vascular Dialysate Flow During dialysis, fluid is removed directly from the

4 Introduction of Dynamics in the Body Three Compartment Model Intracellular Interstitial Circulating Blood Volume Intra-vascular Dialysate Flow During dialysis, fluid is removed directly from the intravascular space through the ultrafiltration process. This space is then refilled with interstitial fluid from the extracellular space (the tissues). Prior to the introduction of the Crit-Line monitor, there were limited ways to measure how well the patient was tolerating the ultrafiltration rate that had been prescribed through dialysis therapy. The plasma refilling rate is the body s ability to shift fluid from the interstitial space into the intravascular space. With the Crit-Line monitor one can directly measure the percent of blood volume change in the intravascular space, and determine how well the body is refilling this compartment during dialysis. Window into your patient s blood stream Vascular space dynamics are key in fluid management Intracellular Interstitial Circulating Blood Volume Dialysate Flow The Crit-Line monitor permits a non-invasive focus on these dynamics

Interpreting the Crit-Line Display Each vertical line represents one hour of time the screen will re-scale if the treatment exceeds 4 hours BV Percent Change (displayed in increments of 5 %) Current

BV Percent Volume Change Graph Current BV Percent Change Value Current O2 Sat Value The Crit-Line monitor provides objective data and visual display of the Relative Blood Volume (RBV) slope as an

5 Interpreting the Crit-Line Display Each vertical line represents one hour of time the screen will re-scale if the treatment exceeds 4 hours BV Percent Change (displayed in increments of 5 %) Current HCT Value Current HgB Value (estimated) Time elapsed since beginning of treatment. The Event Marker (entered by user) is an arrow used to show when an intervention or symptom occurred. BV Percent Volume Change Graph Current BV Percent Change Value Current O2 Sat Value The Crit-Line monitor provides objective data and visual display of the Relative Blood Volume (RBV) slope as an indicator of volume status. Degree of Relative Blood Volume (RBV) slope Intradialytic plasma refill or inability to refill with ultrafiltration Intradialytic plasma refill with minimal ultrafiltration Relative Plasma Volume Relative Plasma Volume (RPV) slopes provide prognostic value to increase or decrease the rate of fluid removal in order to remove the maximum amount of fluid. (Hypertension. 2010; 55: ) An A profile illustrates that ultrafiltration and plasma refilling were equivalent during treatment.

6 A B profile, or gradual slope, has been targeted to find the best compromise between a high ultrafiltration rate and the prevention of intradialytic symptoms. The ideal slope is not a fixed percentage of BV decrease, and will vary from patient to patient. Typical published values seem to range from -1.33%/h to -8%/h depending on patient characteristics and algorithm. Published algorithm in chronic hemodialysis patients suggest a BV change of up to -8%/h in the first hour, with an additional BV change of <-4%/h in the following hours, up to a maximum total BV change of -16% at the end of a 3-4 hour dialysis. 1, 2, 3 Another study suggests a minimal average BV change of >-1.33%/h over four hours to be favorable. 4 All Crit-Line monitor parameters must be considered in conjunction with the patient s clinical assessment, comorbidities and existing medical history before prescribing or changing a dialysis treatment. Any decision regarding patient treatment is the sole responsibility of the attending physician. A C profile describes a dialysis session in which the patient is likely to experience some type of intradialytic morbidity such as lightheadedness, nausea, vomiting, cramping or hypotension; a condition often called crashing. This might occur at a BV change of >-8%/hr 1, 3, 5, 6 or at a total BV 1, 2, 3 change of -16% at the end of a 3 to 4 hr dialysis. Some patients may have a lower tolerance.

On-line HCT monitoring allows for the calculation of plasma volume changes and a comparison of the ultrafiltration and plasma refill rate.

The mismatch in the ultrafiltration and plasma refill rates helps explain the physiology of hypotensive episodes.

Overload Anti-Hypertensive Medications Key Findings from Recent Publications: Therapy guided by RPV slope may serve as a valid tool to better achieve target

7 On-line HCT monitoring allows for the calculation of plasma volume changes and a comparison of the ultrafiltration and plasma refill rate. This may help identify patients prone to intradialytic hypotension. The mismatch in the ultrafiltration and plasma refill rates helps explain the physiology of hypotensive episodes. 5 The Reality of Dialysis Shortened Dialysis Time Crashing Aggressive Dialysis Poor Dialysis Adequacy Re-assess Target Weight Target Weight Not Achieved Overload Anti-Hypertensive Medications Key Findings from Recent Publications: Therapy guided by RPV slope may serve as a valid tool to better achieve target weight using augmented reduction therapy among hemodialysis patients. 4 RPV monitoring yields information that is prognostically important and independent of several risk factors including UF volume, aggressiveness of UF, and interdialytic ambulatory blood pressure. 6 RPV monitoring can assist in better achieving target weight. 7

References: 1. Rodriguez HJ, Domenici R, Diroll A, Goykhman I. Assessment of Dry Weight by Monitoring Changes in Blood Volume During Hemodialysis using Crit-Line. Kidney Int. 68: 854 861, 2005 2.

8 References: 1. Rodriguez HJ, Domenici R, Diroll A, Goykhman I. Assessment of Dry Weight by Monitoring Changes in Blood Volume During Hemodialysis using Crit-Line. Kidney Int. 68: , Goldstein S, Smith C, Currier H. Non-invasive Interventions to Decrease Hospitalization and Associated Costs for Pediatric Patients Receiving Hemodialysis. J Am Soc Nephrol. 14: , Michael M, Brewer ED, Goldstein SL. Blood Volume Monitoring to Achieve Target Weight in Pediatric Hemodialysis Patients. Pediatr Nephrol. 19(4): , Sinha AD, Light RP, Agarwal R: Relative Plasma Volume Monitoring During Hemodialysis Aids the Assessment of Dry Weight. Hypertension. 55: , Schroeder KL, Sallustio JE, Ross EA. Continuous Haematocrit Monitoring During IntraDialytic Hypotension: Precipitous Decline in Plasma Refill Rates. NDT. 19: , Agarwal R. Hypervolemia Is Associated With Increased Mortality Among Hemodialysis Patients. Hypertension. 56: , Agarwal R, Alborzi P, Satayan S, Light RP. Dry-weight Reduction in Hypertensive Hemodialysis Patients (DRIP): A Randomized, Controlled Trial. Hypertension. 53: , 2009 Fresenius Medical Care 920 Winter Street Waltham, MA The Crit-Line Monitor III (CLM III) is a non-invasive hematocrit, oxygen saturation and percent change in blood volume monitor used in the treatment of hemodialysis patients. In addition, the CLM III estimates access recirculation and access blood flow in hemodialysis patients. Caution: Federal (US) law restricts this device to sale by or on the order of a physician or other licensed practitioner. Read the Instructions for Use for safe and proper use of this device. For a complete description of hazards, contraindications, side effects and precautions, see full package labeling Fresenius Medical Care North America. All rights reserved. Fresenius Medical Care, the triangle logo, and Crit-Line are trademarks of Fresenius Medical Care Holdings, Inc. or its affiliated companies. All other trademarks are property of their respective owners. P/N Rev A 01/2013

Crit-Line Monitor. Frequently Asked Questions

Crit-Line Monitor. Frequently Asked Questions Crit-Line Monitor Frequently Asked Questions Crit-Line Monitor Frequently Asked Questions 1 What is the indication for use of the Crit-Line monitor? The Crit-Line Monitor III is used to non-invasively