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DIALYSIS SOLUTIONS INC.PCRRT ConferenceOrlando, FL
June 20th, 2008
CVVH: Bicarbonate vs LactateBarenbrock M et al, Kid Int 58:1951-1957, 2000
Bicarbonate( n = 61)
Lactate( n = 56)
P value
Plasma Bicarbonate (mmol/l)
23.7 + 0.4 21.8 + 0.5 < 0.01
Blood Lactate (mg/dl)
17.4 + 8.5 28.7 + 10.4 < 0.05
IV Bicarb given over 24 hrs
13 + 7 68 + 39 < 0.01
CVVH: Bicarb vs LactateBarenbrock M et al, Kid Int 58:1951-1957, 2000
Dark bar = Bicarb Light bar = lactate
Normocarb HF
• CRRT SHOULD FIX METABOLIC DISTURBANCES, NOT CAUSE THEM.
• Normocarb is the right formulation to provide key electrolytes in the physiologically correct concentrations with no unnecessary components and maximum flexibility.
DSI Milestones
• 1999 – Original Patent for NC35 applied for• 2001 July – Walter O’Rourke joins as consultant• 2001 December – Normocarb receives FDA 510K approval
as device• 2002 January – DSI records first US sales of Normocarb• 2002 June – Pediatric Nephrology: Pediatric Hemofiltration:
Normocarb Dialysate Solution with Citrate Anticoagulation; Bunchman
• 2002 June – BBraun agreement signed• 2002 July – Normocarb receives Canadian DIN• 2003 June – Journal of Critical Care: A Novel Regional Citrate
Anticoagulation Protocol for CRRT Using Only Commercially Available Solutions; Tobe
DSI Milestones
• 2003 December – AJKD: Pediatric Convective Hemofiltration: Normocarb Replacement and Citrate Anticoagulation; Bunchman
• 2005 August – FDA grants Orphan Drug Status to the CRRT indication based on DSI’s application
• 2006 January – FDA 510K Approval for NC25• 2006 May – Canadian Patent issued on NC25• 2006 July – DSI receives an NDA for NC25HF/NC35HF• 2006 November – DSI launches HF Products• 2007 August – DSI receives US patent for 25 bicarb
products
Therapy Evolution
• Diffusion based dialysis requiring device or combination product approved solutions
• Citrate • Hemofiltration dialysis requiring drug approved
solutions• Volume
Solution Evolution
• Lactate Buffered – PD Solutions – Dialysate• Pharmacy Made – Calcium Containing –
Bicarbonate Solutions – Dialysate• Citrate• Pharmacy Made – Calcium Free – Bicarbonate
Solutions – Dialysate• Add Mixture Pharmacy Solutions – Calcium Free –
Bicarbonate – Dialysate• Normocarb – Calcium Free – Dialysate• Normocarb NDA as hemofiltration solution for
direct infusion
Normocarb HF
•Dialysate vs. Hemofiltration Solution
Normocarb 35 HF
• NC 35 HF• mEq/L• Sodium (Na) 140• Magnesium (Mg) 1.5• Chloride (Cl) 106.5• Bicarbonate (HCO3) 35• Potassium (K) 0• Calcium (Ca) 0
Normocarb 25 HF
• NC 25 HF• mEq/L• Sodium (Na) 140• Magnesium (Mg) 1.5• Chloride (Cl) 116.5• Bicarbonate (HCO3) 25• Potassium (K) 0• Calcium (Ca) 0
Normocarb HF
• Simple Preparation• Maximum Flexibility
– Potassium can be added.– Calcium can be added– Dextrose can be added