Download Normocarb Workshop - Pediatric Continuous Renal

DIALYSIS SOLUTIONS INC.
PCRRT Conference
Orlando, FL
June 20th, 2008
CVVH: Bicarbonate vs Lactate
Barenbrock 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
68 + 39
< 0.01
IV Bicarb given over 24 13 + 7
hrs
CVVH: Bicarb vs Lactate
Barenbrock 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)
Magnesium (Mg)
Chloride (Cl)
Bicarbonate (HCO3)
Potassium (K)
Calcium (Ca)
140
1.5
106.5
35
0
0
Normocarb 25 HF
• NC 25 HF
• mEq/L
•
•
•
•
•
•
Sodium (Na)
Magnesium (Mg)
Chloride (Cl)
Bicarbonate (HCO3)
Potassium (K)
Calcium (Ca)
140
1.5
116.5
25
0
0
Normocarb HF
• Simple Preparation
• Maximum Flexibility
– Potassium can be added.
– Calcium can be added
– Dextrose can be added