Large RCT s s in RRT : What can be learnt for nursing?

Transcription

1 Large RCT s s in RRT : What can be learnt for nursing? Ian Baldwin Dept. of Intensive Care, Austin Hospital Adjunct Professor, RMIT University CRRT 2011 Hilton Bayfront, February SanDiego

2 Key Hypothesis RRT in AKI Critically Ill Ultrafiltrate/dia-filtrate Mortality/Outcome Dose = VOLUME of UF per hr, indexed for body weight X no. hrs treated

3 Published in the The Lancet, ml/kg/hr; or 35 ml/kg/hr; or 45 ml/kg/hr CUMULATIVE PROPORTION SURVIVAL Group 3 (p = ) Group 2 (p = ) Group Survival Time (Days) Ronco C, Bellomo R, Brendolan A, Dan M, Piccinni P, La Greca G. Effect of different doses in continuous veno venous hemofiltration on outcomes of acute renal failure.

4 Geneva, Switzerland, Comparative Study of CVVH and CVVHDF Saudan et al, Kidney Int ml/kg/h

5 Survival Comparison: CVVH vs CVVHDF Saudan et al, Kidney Int ml/kg/hr 25 ml/kg/hr

6 2006

7 More RRT is Better Odds Ratio: 1.95 (95% CI , p < 0.001) Forrest plot pooling trials of RRT dose Study n treatment groups Ronco 425 CVVH 20/h vs ml/kg/h* Bouman 106 CVVH 20ml/kg/h* vs. 48 ml/kg/h Schiffl 160 Alternate day vs. daily hemodialysis Saudan 206 CVVH 25 ml/kg/h vs. CVVHDF 42 ml/kg/h Total (fixed effects) Total (random effects) Kellum, Nat Clin Pract Nephrol Odds ratio Favors increased dose!

8 Therapy Dose in ARF: Expert Recommendation in 2007 Patients with ARF should be treated with at least 35 ml/kg/h of hemofiltration/ hemodiafiltration or daily hemodialysis until or unless ongoing multi-center clinical trials show otherwise. Kellum JA, Nature Clinical Practice Nephrology, 2007

9 Birmingham, Alabama, USA 2008

10 20 ml/kg/hr 35 ml/kg/hr

11 Tolwani et al. 2008

12 Dose matters?? Dose and high volume CRRT on the Radar now..increase in UF rate ( high volume) what did it mean for patients, but also for nursing management of this????

13 RRT dose & mortality :Key dose trials

14 Dose of RRT: The VA/NIH study Published 2008

15 VA/NIH ARF Study (ATN) USA 1164 patients 31 sites (24 VA, 7 other) 3 years Randomization Stable hemodynamics (SOFA 0-2) Unstable hemodynamics (SOFA 3-4) Intensive Management Strategy (582 patients) IHD Kt/V of ~1.2/session 35 ml/kg/hr, or SLED/EDD 6x/week Conventional Management Strategy (582 patients) IHD Kt/V of ~1.2/session 20 ml/kg/hr, or SLED/EDD 3x/week

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17 Time in ICU before starting RRT? Longest time between ICU admission and start of therapy in the literature

18 Highest rate of hypotension reported in the literature

19 RENAL Randomised Evaluation of Normal vs Augmented Level renal replacement therapy A collaboration of: Australia and New Zealand Intensive Care Society Clinical Trials Group, The George Institute for International Health (University of Sydney) Published 2009

20 RENAL Investigators: NEJM Oct 22, 2009

21 Mode CVVHDF AN69 membranes Blood flow > 150mL/min Intervention Fluids Post-dilution fluid replacement Bicarbonate-based dialysate and replacement fluid Dialysate to replacement ratio of 1:1 Effluent flow of 25 ml/kg/hour (low dose) Effluent flow of 40 ml/kg/hour (high dose) RENAL Investigators: NEJM 2009

22 Processes of care Study treatment High intensity N=722 Low intensity N=743 p Duration of CRRT (days) 6.3 ± ± Flow rate of effluent (ml/kg/hr) 33.4 ± ±17.8 <0.001 % dose delivered 84% 88% <0.001 Morning creatinine 170 ± ± 115 <0.001 Filters used/day 0.93 ± ± 0.81 <0.001 Hypophosphataemia 65.1% 54% < RENAL Investigators: NEJM 2009

23 Mortality No. ( %) No. ( %) RENAL Investigators: NEJM 2009

24 Conclusions : ATN and RENAL RENAL Investigators: New Eng J Med 2009 VA/NIH Acute Renal Failure Trail Network: New Eng J Med 2008; 359

25 Comparison within single centre Variable Ronco (2000) Tolwani (2008) Saudan (2006) enrolled Mean age Male (%) Weight Sepsis (%) % delivered dose ICU Days before random Urea at baseline mg/dl 29.5 SOFA score APACHE 11* 22.6* 26* 9.5 Ventilation

26 Comparison with VA/NIH Study Variable RENAL VA/NIH enrolled Mean age Male (%) Weight Sepsis (%) Pre-rand Rx (%) ICU Days before random Urea at baseline Total SOFA score (resp, CVS, liver, coag) Ventilation 73.9% 80.6% Prescribe dose delivered 86 (21hrs*) 92 (21 hrs*)

27 Pooled findings from RRT trials. RRT patients in the ICU, worldwide : 5 trials (2 multi centre RCT s*) Age 61.6 yrs Male 66.6 % Weight 79.4 kg Ventilation* Filter life* 21 hrs Prescribed dose 85.5 %

28 Pooled findings from RRT trials. RRT patients in the ICU, worldwide : 5 trials (2 multi centre RCT s*) Dose : a new concept in ICU. based on patient weight (mls/kg/hr) and then relied on delivery (hrs On treatment). eight estimated, not known, prescribed less than delivered.. ew electrolyte problems emerged; low phosphate omplications documented; Hypotension

29 Lesson 1: Accurate patient weight important for CRRT going forward. Often estimated, with high error rate Estimation influenced dose prescribed within a group Limited access to trial with some patients e.g. over estimated weight where exclusion was 100 KG Evidence for a relationship between weight gain and mortality.! Need to establish reliable weighing for ICU patients?

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31 Pt Weight for trials? Actual weight Method used Ronco, Italy No From previous med records, family Saudan, Geneva, Switzerland Tolwani, Alabama, USA Not described Yes, on day of randomisation No Not described RENAL, Aus. & N.Z. Yes, on day of randomisation 27% measured 73% not described, (guess, estimated) ATN VA/NIH Pre illness onset weight Not described

32 My ICU 50 ICU admissions audited : 99% no height or weight

33 The most frequent error was overestimation in weight ( 59.9%)... Overall : ICU physicians and nurses underestimated weight by > 20 %, 15.6 % cases ICU physicians and nurses underestimated weight

34 Importance of correct weight..renal study example 80 kg correct weight 10% 88 kg 10 % 72 kg Over at 20% 96 kg Under at 20% 64 kg 25 ml/kg/hr 40 ml/kg/hr 2 L/hr 3.2 L/hr 1.2 L/hr 2.2 L/hr 2.4 L/hr 2.88 L/hr 0.68 L/hr 2.56 L/hr 0.16 L/hr Difference in hrly UF rate

35 A better assessment of fluid overload.+ve fluid balance and outcome findings emerging. 2001

36 68 yrs Female SOB R heart fail Kg on admit 10 days CRRT 89.0 Kg Loss by FBC=22.5 kg

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38 Fluid overload and outcomes in AKI (5 publications for a starter ) 1. Foland J A et al. Fluid overload before cont. hemofiltration and survival in critically ill children; a retrosptective analysis. Crit Care Med. 2004; Goldstein S et al. Outcome in children receiving continuous venovenous hemofiltration. Pediatrics Payen D, et al. A positive fluid balance is assoc. with a worse outcome in patients with acute renal failure. Crit Care 2008; Bagshaw s et al. Fluid balance as a biomarker: impact of fluid overload on outcome in critically ill patients with acute kidney injury. Crit care 2008;12 5. Bouchard J et al. Fluid accumulation, survival and recovery of kidney function in critically ill patients with acute kidney injury. Kidney Int. 2009;76

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40 +ve fluid balance and outcome. Fluid accumulation > 10 % = fluid overload

41 Weight not easily done in ICU. Variability in different methods / scales

42 Accurate patient weight Tare the bed before admission

43 PLEASE RETURN TO ICU Patient s details The WHIP Study Schneider A, et al. (Weigh with Hill-Rom ICU Patients) Daily weight of ICU patients in a Hill-Rom bed _ Not on Hill-Rom Bed (label the form and drop in pigeon hole) Date Time (24:00 to 01:00 AM) Weight (Kg) Fluid balance (SLIC) (midnight) Intubated (Y/N) Peak T (last 24hrs) Bed taring includes: - 1 pillow case - 1 pillow - 2 slide sheets - 2 large sheets - 1 blanket - 1 gown - 1 pinkie - Foot-end. BED CALIBRATED on the. /../ 20 by... Weighing procedure: - Weight should be measured every day at midnight - Head of bed should not be tilted by more than 30 - Remove (or hold): (if not possible, refer to the table at the back and substract their weight to the measurement) - sheets or extra pillows not listed in the bed taring box - urinary bags - disinfectant bottles - drains bottles - iv pole and its attachments at the bed head don t have to be removed - Press the weigh patient button

44 Testing the Mercury Scale system

45 Lesson 2. Difficulties achieving prescribed dose. ( Dose = UF rate ml/kg/hr X hrs treated) Need to accurately record the consecutive hrs of treatment per day On time and OFF time Need to coordinate care to reduce interruptions and then delays in restarting RRT after Definition of filter clotting circuit failure Failure and OFF time due to staff competence / lack of expertise Need to increase UF rate to compensate for the OFF time!

46 Nursing expertise measurement by amount of time with machine off patient Percentage of off time Vs on time (CRRT, Austin ICU Australia, 2003) off time 22% 5.27hrs without treatment per day on time 78% (Venkataraman R & Kellum J Critical Care Vol. 5 S % off time or 16.1 hrs on CRRT)

47 Coordinating procedures/ transports ; minimizing interruptions

48 Know your own results : filter life and ON- OFF time Fast bedside record; consecutive hours for each circuit and in between. ICU CHART Anticoag. dose Filter hrs 1,2,3,4,5, On Off On Off On

49 Median* Filter life data Mean = hrs (NB: 2 RCT s 21 hrs) Hrs

50 Diagnosing filter clotting. Looks clotted? +ve + Diagnosis of filter clotting High Pin press > 250 High TMP > 250 *Press _Post > 26 +ve +++ Air trap Blood pump to patient. +ve pressure +ve + from patient. ve pressure *Bierer P & Holt A, Anaesth and Int Care (4)

51 Nurse 1 Nurse 2 Human patient & machine interface Staff training and education!

52 Lesson 3: Hypotensive episodes, Lesson 4: Hypophosphataemia (VA/NIH) 9.8% intensive, 8.7% less intensive group associated with cessation of therapy. (RENAL) Hypophos. in 65.1% intensive and 54 % in less intensive Nursing measures can reduce hypotension Relationship to fluid loss targets prescribed Starting RRT, vasopressor dependent patients Phosphate can be monitored more closely Replacement protocols can be used similar to Potassium

53 Why hypotension - common? Fail to connect both lines blood letting Prime exchange crystalloid, not colloid Too fast blood flow depletes venous pool and drops right heart pressure Inadequate MAP prior Loss of dynamic response circuit is dead

54 Why hypotension, less common? Reaction to membrane and or prime solution Arhythmia during connection..e.g. AF Vasopressor, removed from circulation as blood flow starts CVC and access together Air embolus from circuit Heated prime solution - vasodilation

55 Prep. Start Recheck machine - circuit Prep patient- supine, 20, MAP > 80 mmhg via I/A line, no arrhythmias, IV bolus ready Baldwin, CCN07 2 nurses, connect both lines to access, admin. prime vol. Set blood pump to mls/min. Increase in increments Monitor ABP via arterial line BP Ok : pump speed gradually to treatment speed BP : bolus vol. IV vasopressor wait Treat Circuit full of blood, BP blood flow 1-2 hrs remove fluid, reduce vasopressor Start fluids & treatment

56 Hypophosphataemia (RENAL)

57 Not a new idea...(troyanov et al. CCM 2004)

58 Phosphate added Gambro phoxilium* K+ = 4.0 mmol/l Phosphate = 1.2 mmol/l *Under evaluation, not commercially available yet

59 Lesson 5: Machine settings : Nomenclature As reflected in the publications it is also evident that different machines were used, in different centers and that terminology to describe a treatment prescription varied. Mistakes were made.not captured in data collection..

60 Machine settings : Nomenclature Machine Setup Non standardised nomenclature and misunderstanding of the language on different CRRT machines: Fluid exchange rate or turnover or flow rates Ultrafiltration or filtrate volume or effluent Fluid loss or weight loss or patient balance Machine loss or patient loss Volume or flow Substitution or replacement

61 3628* critically ill patients were treated with a low complication rate. This is a testament to the advances in nursing expertise, and machine technology in the field of CRRT! * 5 studies reviewed

62 ack to where we started.80 Kg at 25ml/kg/hr = 2 L/hr Limited to 2 L/hr Gambro BMM 10-1 module & IV pumps 1980 s

63 Conclusions: Nursing lessons from RCT s. Practice styles vary world wide Patients are ~ 60yrs, 80kg, > male Filter life ~ 21 hrs Hypotension nursing target to reduce incidence Phosphate replacement more likely now ongoing Accurate patient weight needed in adult ICU ; Fluid overload and poor outcomes! Need to revisit nomenclature and settings terminology Prescribed Vs Delivered dose record filter life and minimise interruptions

64 Final.