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Daily and Nocturnal Hemodialysis. Alan S. Kliger MD Hospital of St. Raphael Yale University School of Medicine New Haven CT. Best Opportunities to Improve Outcomes. Increase Dialysis Dose Reduce Inflammation Decrease LVH Restore fluid balance and BP Reduce Sympathetic Activity

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Daily and nocturnal hemodialysis

Daily and Nocturnal Hemodialysis

Alan S. Kliger MD

Hospital of St. Raphael

Yale University School of Medicine

New Haven CT


Best opportunities to improve outcomes
Best Opportunities to Improve Outcomes

Increase Dialysis Dose

Reduce Inflammation

Decrease LVH

Restore fluid balance and BP

Reduce Sympathetic Activity

Reduce Depression


Cardiovascular disease mortality general population vs esrd patients
Cardiovascular disease mortalitygeneral population vs ESRD patients

100

10

GP Male

1

GP Female

GP Black

0.1

GP White

Dialysis Male

0.01

0.001

25-34

35-44

45-54

55-64

66-74

75-84

>85

Annual CVD Mortality (%)

Dialysis Female

Dialysis Black

Dialysis White

Age (years)

Foley RN, et al. Am J Kidney Dis. 1998;32:S112-S119.

GP = General Population.


4


5


HEMO Study: Survival by dose group

1,846 Patients

Eknoyan et al, N Eng J Med 2002


BREAST

CANCER

HIV

PROSTATE

CANCER

THE DEATH-RATE

WAS THREE TIMES

THAT OF BREAST

CANCER AND HIV,

TWICE THAT OF

PROSTATE CANCER

Slide courtesy of Dr. Kjellstrand

HEMO


Post hoc analysis of hemo study

Mean = 2.19 Mean = 2.53

2.88

2.59

Weekly Std Kt/V

2.30

2.02

Standard

Dose

High

Dose

Post-Hoc Analysis of HEMO Study

Limited separation between treatment groups for unified dose measures, such as

Standard Kt/V ≅ [urea generation rate] / [average (C0)]

Separation in Std Kt/V in HEMO Trial

Only 16% difference

in mean Std Kt/V

between dose groups


Effect of increasing length of dialysis

Three sessions per week

7

6

5

HEMO: High

4

Weekly Dialysis Dose (stdKt/V)

3

2

1

HEMO: Standard

0

0.0

0.5

1.0

1.5

Dialysis dose each dialysis (eKT/V)


Effect of increasing number of

dialysis sessions per week

7

Hemodialysis

Daily

Dialysis

6

sessions/wk

6

5

HEMO: High

4

Weekly Dialysis Dose (stdKt/V)

3

3

2

1

HEMO: Standard

0

0.0

0.5

1.0

1.5

Dialysis dose each dialysis (eKT/V)


Daily hd summary of findings
Daily HD – Summary of Findings

12

Suri R. et al. CJASN 1:33-42, 2006


Retrospective analysis of survival for 415 patients treated with short daily hemodialysis
Retrospective Analysis of Survival for 415 Patients Treated with Short Daily Hemodialysis

  • 10 year survival: 42+9%

  • Compared with matched patients from USRDS:

    • Daily dialysis patient survival was 2-3 times higher

    • Predicted survival times were 2.3 -10.9 yrs longer for daily dialysis patients

Kjellstrand et al NDT 23:3283, 2008


C with Short Daily Hemodialysis

U

M

S

U

R

V

I

V

A

L

SHORT DAILY

HOME HD

N=265

USRDS

CAD TX

2005

USRDS

PD AND HD

SURVIVAL

Slide courtesy of Dr. Kjellstrand


Nocturnal hd summary of findings
Nocturnal HD – Summary of Findings with Short Daily Hemodialysis

Walsh M et al. Kidney Int 67:1500-1508, 2005

15

Walsh M et al Kidney Int 67: 1500-1508, 2006


Alberta rct nocturnal hd vs conventional hd
Alberta RCT Nocturnal HD vs Conventional HD with Short Daily Hemodialysis

Primary Outcome: Change in LV mass

52 patients randomized

44 had baseline MRI

35 had follow-up MRI after 6 months

No second MRI

6 refused

2 transplanted

1 died

Culleton et al JAMA 298:1291, 2007

16


Result lv mass gm sd
Result: LV Mass Gm (SD) with Short Daily Hemodialysis

Estimated Treatment Effect on LV Mass (Gm)

Last observation carried forward (n=44): 15.3, CI (+1.0, +29.6 )

Observed data only (n=35): 19.7, CI (+1.9, +37.4 )

Culleton et al JAMA 298:1291, 2007

17


Nocturnal home hemodialysis nhhd
Nocturnal Home Hemodialysis (NHHD) with Short Daily Hemodialysis

Nocturnal Hemodialysis Improves Erythropoietin Responsiveness and Growth of Hematopoietic Stem Cells

  • 16 patients switched from conventional HD to NHHD

  • Kt/V urea increased from 1.27+0.06 to 2.23+0.09

  • Phosphorus and PTH levels fell

  • BP and BP medications fell

Chan JASN Express Dec 17 2008


Nocturnal home hemodialysis nhhd1
Nocturnal Home Hemodialysis (NHHD) with Short Daily Hemodialysis

  • Hb rose from 11.3+0.3 to 12.5+0.4 Gm/dL with no change in EPO or iron

  • Cell culture studies and gene profiling showed up regulation of genes responsible for hematopoetic progenitor cells after more intensive HD.

  • NHHD increases growth and production of RBCs.

Chan JASN Express Dec 17 2008


Frequent hemodialysis network
Frequent Hemodialysis Network with Short Daily Hemodialysis

2 parallel RCT

  • Comparing in-center 6x/wk dialysis to conventional 3x/wk dialysis

  • Comparing home nocturnal 6x/wk dialysis to conventional 3x/wk home dialysis


Fhn study designs
FHN Study Designs with Short Daily Hemodialysis

Compare outcomes

after 1 year

Compare outcomes

after 1 year

Daily In-Center

Patients from 10

regional centers

Nocturnal

Patients from 9

regional centers

250 pts

randomized

over 46 mo.

90 pts

randomized

over 27 mo.

1.5 months

training +

12 months

6x/Week

Nocturnal HD

12 months

3x/Week

Conventional

Home HD

12 months

6x/Week

Daily

In-center HD

12 months

3x/Week

Conventional

In-center HD


Standard weekly kt v urea
Standard weekly Kt/V urea with Short Daily Hemodialysis


Phosphorus removal
Phosphorus removal with Short Daily Hemodialysis


Beta 2 microglobulin clearance
Beta-2-microglobulin clearance with Short Daily Hemodialysis


Co primary outcomes
Co-Primary Outcomes with Short Daily Hemodialysis

Composite of 1-year mortality and change in LV mass by cardiac cine-MRI

Composite of 1-year mortality and change in RAND PHC from SF- 36

25


9 main outcome domains
9 Main Outcome Domains with Short Daily Hemodialysis


Clinical centers for daily trial rri and ucsf stanford cores
Clinical Centers for Daily Trial with Short Daily HemodialysisRRI and UCSF/Stanford Cores

Univ. of Western Ontario – Dr. Robert Lindsay

Washington Univ. (MO) – -- Dr. Brent Miller

RRI: New York City (NY) – Dr. Peter Kotanko

Vanderbilt University (TN) – Dr. Gerald Schulman

Wake Forest University (NC) – Dr. Michael Rocco

UCSF/Stanford

– Dr. Glenn Chertow

Univ. California, Davis – Dr. Thomas Depner

Peninsula Dialysis: (CA) –Dr. George Ting

UCLA – Dr Anjay Rastogi

UCSD – Dr. Ravindra Mehta

27


Clinical centers for nocturnal trial
Clinical Centers for Nocturnal Trial with Short Daily Hemodialysis

Univ. of British Columbia – Dr. Michael Copland

Humber River Hosp

– Dr. Andreas Pierratos

University of Toronto – Dr. Chris Chan

Univ. of Western Ontario – Dr. Robert Lindsay

Rubin Dialysis (NY) – Dr. Christopher Hoy

University of Iowa – Dr. John Stokes

Lynchburg Nephrology – Dr. Robert Lockridge Jr.

Wake Forest University

– Dr. John Burkart

Washington University – Dr. Brent Miller


Randomized subjects
Randomized Subjects with Short Daily Hemodialysis

Daily Nocturnal

Goal 250 90

Enrolled 378 118

Randomized 245 81


Trial timelines
Trial Timelines with Short Daily Hemodialysis

DailyNocturnal

Randomization Ends 3/2009 5/2009

Study Period Ends 3/2010 5/2010

Report Results late 2010-2011


Cost effectiveness of frequent in center hemodialysis
Cost-Effectiveness of Frequent in-Center Hemodialysis with Short Daily Hemodialysis

  • Monte Carlo simulation model

  • Inputs:

    • Various frequencies and duration of HD (3-6x/wk, 2-4.5 hrs/session)

    • Outcomes: costs, life expectancy, QALY

    • Assumptions on potential effects of frequent dialysis on outcomes – (ex: 32% reduction in mortality with 6x/wk)

Lee CO et al JASN 19:1792, 2008


Cost effectiveness of frequent in center hemodialysis1
Cost-Effectiveness of Frequent in-Center Hemodialysis with Short Daily Hemodialysis

  • Incremental cost-effectiveness ratio will be at least $75,000/ life year gained

  • None of the strategies using 6x/wk HD achieved a cost-effectiveness ratio of < $125,000/ life year gained

Lee CO et al JASN 19:1792, 2008


Cost effectiveness of frequent in center hemodialysis2
Cost-Effectiveness of Frequent in-Center Hemodialysis with Short Daily Hemodialysis

How could costs “break even”?

  • If the per-session costs were reduced between 32 and 43%

  • Reduction in hospitalization rate

    • For 4 HD/wk, need to reduce hospitalization to 46% of current rate

    • For 5 HD/wk, need to eliminate hospitalizations

Lee CO et al JASN 19:1792, 2008


Cost effectiveness of frequent in center hemodialysis3
Cost-Effectiveness of Frequent in-Center Hemodialysis with Short Daily Hemodialysis

Conclusions

  • More frequent in-center HD strategies would likely increase ESRD program costs considerably.

  • Transition to home-based therapies will be required to derive any benefit that might be present without incurring excessive costs.

Lee CO et al JASN 19:1792, 2008


In center nocturnal hd inhd
In-Center Nocturnal HD (INHD) with Short Daily Hemodialysis

  • 16 patients in New Haven switched from conventional to INHD

    • Kt/V urea rose from 1.2+0.16 to 2.6+0.65

    • UF rate fell from 10.3+4.5 to 5.9+1.7 mL/hr/kg

    • Phosphorus fell from 5.3+1.3 to 4.4+1.1mg/dL

    • No change in psychosocial assessments (QoL)

Troidle Adv Chronic Kid Dis 14:244,2007


In center nocturnal hd inhd1
In-Center Nocturnal HD (INHD) with Short Daily Hemodialysis

  • 39 patients in Toronto switched from conventional to 8 hr INHD

    • URR increased from 74% to 89%

    • Phosphorus fell from 5.9 to 3.7 mg/dL

    • Number of antihypertensive drugs: 2.0 to 1.5

    • ESA use fell significantly

    • QoL, sleep, intradialytic cramps, appetite, energy level all improved significantly

Bujega CJASN April 2009


In center nocturnal hd inhd2
In-Center Nocturnal HD (INHD) with Short Daily Hemodialysis

  • 224 pts in Turkey switched from conventional to 8 hour INHD

    • Compared prospectively with matched cohort 224 pts on conventional 4 hour HD 3 days/wk

    • INHD patients had

  • 25% hospitalization rate

  • 78% reduction in mortality

  • Less intradialytic hypotension, lower phosphate, reduced arterial stiffness

  • Improved cognitive function

Ok E: ASN abstract F-FC-317 2008


Frequent hd in usa current status
Frequent HD in USA: Current Status with Short Daily Hemodialysis


Nxstage growth 2004 to 2008
NxStage Growth 2004 to 2008 with Short Daily Hemodialysis

Courtesy Dr Lockridge


International quotidian dialysis registry
International Quotidian Dialysis Registry with Short Daily Hemodialysis

  • Standard Daily HD: >2 hrs, 5-7x/wk

  • Nocturnal HD: > 6 hrs, 3-7x/wk

  • Enrollment as of Mar, 2009:

    US 1,260

    ANDATA 1,210

    Canada 225

    Total 2,695

Nesrallah GE, on behalf of the quotidian dialysis international working group


Conclusions
Conclusions with Short Daily Hemodialysis

  • More intensive dialysis is needed to improve ESRD patient outcomes

  • Observational trials suggest better anemia care, phosphorus control, fluid and BP management with intensive HD

  • Retrospective analysis shows improved survival with intensive dialysis


Conclusions1
Conclusions with Short Daily Hemodialysis

  • Frequent in-center HD (4-6 HD/wk) is more costly - unless per-treatment HD costs fall

  • Frequent home HD (4-6HD/wk) is increasing slowly

  • NHHD is promising, but utilized by few patients

  • INHD is the fastest growing – in US and internationally - with more efficient use of facility space improving financial viability


Conclusions2
Conclusions with Short Daily Hemodialysis

  • RCT of NHHD and daily in-center HD in progress

  • International Quotidian Dialysis Registry may give us meaningful information on the effect of intensive HD on mortality and hospitalization


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