Dialysis and Replacement Solutions Bicarbonate vs' Lactate Industry vs' Pharmacy Produced

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Dialysis and Replacement SolutionsBicarbonate
vs. LactateIndustry vs. Pharmacy Produced
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Objectives

• Define replacement/substitution fluid
• Describe the composition of replacement fluids
• Discuss the purity of solutions for CRRT
• Discuss on-line production

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Definition of replacement fluid

• Solute removal by CRRT occurs by
• Convection (CVVH)
• Diffusion (CVVHD)
• Combination of both (CVVHDF)

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Definition of replacement fluid

• Convection uses solvent drag to remove solutes
  and is enhanced by increasing the volume of
  ultrafiltrate produced

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Definition of replacement fluid

• CRRT techniques using convective clearance
  require the replacement of fluid removed to
  prevent dehydration

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Definition of replacement fluid

• The composition of replacement fluid can be
  altered to achieve any specific change in plasma
  composition
• The ideal replacement fluid resembles normal
  plasma or extracellular fluid

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Composition of replacement fluid

• Replacement fluids should contain a buffer and
  electrolytes in physiological concentrations
• Commercial solutions
• Customized solutions

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Composition of replacement/dialysate solutions

• Sodium
• Glucose
• K, Ca2, Mg2, PO42-
• Anionic Base

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Anionic Base

• Lactate
• Bicarbonate
• Citrate

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Anionic base lactate

• Disadvantages
• Potential hemodynamic compromise, increased
  urea generation, cerebral dysfunction
• Conversion to bicarbonate impaired in liver
  dysfunction

• Advantages
• 1-1 conversion to
  bicarbonate
• Convenient storage

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Anionic base bicarbonate

• Advantages
• Potentially improves hemodynamic stability

• Disadvantages
• Difficult to store due to instability
• Forms insoluble
• salts with Ca2 and Mg2
• Increased risk of bacterial contamination

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Anionic base citrate

• Advantages
• Can be used as an anti-coagulant
• 1-3 conversion to bicarbonate

• Disadvantages
• Can result in metabolic alkalosis or
  worsening acidosis
• Requires a systemic calcium infusion

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Customized replacement solutions

• Manual preparation with sterile solutions
• On-line preparation

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Purity of solutions

• Replacement fluid must be sterile and
  pyrogen-free since directly infused into the
  patients blood
• Commercial solutions steam sterilized by
  autoclaving
• Need for purity of dialysate is controversial and
  depends on back-diffusion and back-filtration

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Classification of water and dialysate quality
Adapted from Lonnemann. Nephrol Dial Transplant
2000 ADQI.net
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On-line production of replacement fluid

• Continuous preparation and immediate use of
  solutions of specific composition and quality
• On-line preparation may be safe, efficient, and
  cost-effective when properly performed

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On-line production of replacement fluid

• Extensive evaluation of the safety only been done
  in ESRD
• Fluids are filtered through a membrane that is
  permeable to water and electrolytes, but
  impermeable to bacteria and pyrogens

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Solutions

• Hemodialysis uses Bicarbonate based
• PD uses lactate based
• Not due to preferred solution but due to the fact
  of bicarbonate leaching thru plastic PD bag
• CRRT uses local standard with trend to bicarbonate

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Bicarbonate vs LactateDoes it make a difference?

• Lactate is not thought to be a direct toxin yet
  rising lactate levels (due to patient of lactate
  based solutions) may lead to investigation of
• Sepsis
• Bowel necrosis
• Poor tissue perfusion
• (patients on lactate based solutions usually run
  lactate levels of 3-4 meq/l from the solution
  itself)

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HC03 vs LactateZimmerman et al, Nephl, Dial,
Transpl, 142387-2391, 1999

• Randomized crossover design
• Each patient to receive 48 hours of lactate based
  dialysate (peritoneal dialysis fluid 1.5) and 48
  hours of bicarbonate based dialysate (Normocarb
  equivalent)
• order of 48 hour block randomized

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Composition of Dialysates
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Summary of results at baseline and after each 48
hour block.
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Peds HCO3 vs adapted Lactated Ringers
soln(Maxvold et al, Blood Purif 1727, 1999)

• HCO3 (40 meq/l) vs LR 10 meq/l HCO3
• 24 hr cross over study
• metabolic and hemodynamic monitoring
• Pediatric patients only

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Comparison of Pharmacy made solution vs LR soln
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HCO3 vs Adapted LR soln
Lactate Levels
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CVVH Bicarb vs LactateBarenbrock M et al, Kid
Int 581951-1957, 2000
61 pts on Bicarb
56 pts on lactate
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CVVH Bicarb vs LactateBarenbrock M et al, Kid
Int 581951-1957, 2000
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CVVH Bicarb vs LactateBarenbrock M et al, Kid
Int 581951-1957, 2000
Dark bar Bicarb
Light bar lactate
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CVVH Bicarb vs LactateBarenbrock M et al, Kid
Int 581951-1957, 2000
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What are available?

• Replacement
• No industry only pharmacy made
• Dialysis (US outside US)
• Bicarbonate Based
• Normocarb (Dialysis Soln Inc)
• Hospal BO (Hospal)
• Lactate Based
• Hemofiltration Soln (Baxter)
• Hospal LO (Hospal)

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Replacement Solutions

• Normal Saline
• Lactated Ringers
• Pharmacy made solutions
• NONE OF THESE ARE FDA APPROVED!

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Pharmacy made solutions

• Hospital based pharmacy
• Industry based for custom made solutions
• CAPS
• Compass

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Dialysis solutions and the FDA
FDA
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Pharmacy made solutions
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Old orders

• Na 140 meq/l
• Cl 105 meq/l
• HCO3 35 meq/l
• KCl 2 meq/l
• K3PO4 2 meq/l

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C.V.V.H Medication Errors

• Compounding errors
• Medication Order interpretation
• Clutter
• Physician orders handwritten
• (reading bunchmans handwriting is a risk by it
  self!)

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C.V.V.H Preparation
? Manipulate multiple additives ? Base solution
has to be pumped ? Increase labor cost ?
Increase risk of port leakage ? Start to finish
QA process up to 45 minutes ? Constant labor
involvement ? Increased error rate
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Custom made solutionsRisk and Benefits

• Advantage
• Taylor make solutions to the need of the child
• Disadvantage
• Pharmacies lack QA
• Many programs have reported non fatal and fatal
  complications due to pharmacy solution errors

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Dialysis Solutions
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Dialysis solutions and anticoagulant
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Normocarb

• First used 12/25/01 in US _at_ CHA
• gt 200 patient days since first use
• Pharmacy cost cut by 40
• Avoids pharmacy risks of error and hospital
  liability

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Dialysis Solutions
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Liability of Dialysis Solutions
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Normocarb FDA approved bicarbonate based Ca free

• Normocarb contains
• 140 meq/l Na
• 35 meq/l HCO3
• 105 meq/l Cl
• 1.5 meq/l Mg
• When added to a 3 liter of sterile H2O (Baxter)
• lt 15 mins to commence CVVHD

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Normocarb and Citrate

• Allowed for industry standard with minimal risk
  of physician hand writing or pharmacy error
• 4 bags to arrange for CVVHD
• Normocarb
• NS (ie replacement fluid)
• ACD-A
• CaCl

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NormoCarb Base Preparation

• Manipulate only two products for base
• Decreased risk of port leakage
• NormoCarb transfer within minutes
• Minimal labor costs
• 48 hour expiration for base product
• K products added just in time
• Start to finish QA process gt5 minutes
• Start walk away
• decreased error rate

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Research in this field
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Solutions conclusion-1

• The proper way to do hemofiltration is the way it
  is done best locally
• CVVH requires replacement solutions for
  convective clearance and for prevention of
  dehydration
• CVVHD requires no replacement fluid but uses
  diffusive clearance
• For small molecular wt solute either will suffice

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Solutions conclusion-2

• Bicarbonate based solutions appear to be more
  physiologic then lactate based with improved
  hemodynamic stability
• Pharmacy made solutions have the benefit of
  allowing for tailor made prescriptions but are at
  risk for error and increase in liability
• Dialysis solutions offer industry standard and
  choice of bicarbonate or lactate based