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Advanced Renal Technologies Inc. WA. USA (ART) has developed a new dialysate formulation that addresses patients needs and brings treatment to a more effective level. Containing Citric Acid as the acidifying agent, it is the first major change in dialysate formulation in over 30 years, breaking away from traditional formulations that contain acetic acid. It is cleared for use by the FDA for all patients, is already on the market and is in use in many clinics around the world.

Advanced Renal Technologies, Inc. provides an advanced dialysis fluid concentrate (dialysate) formulation containing citric acid. DRY Citrasate is DRYalysate® , a dry powdered version that can be mixed by the user to make A concentrate. The use of citric acid in the dialysate offers a safe and effective way to provide dialysis therapy. Citrate dialysis provides improved treatment for patients on routine long-term hemodialysis. Citrate dialysate is safe and effective in all dialysis patients. DRY Citrasate is available in all standard formulations.

Shifa Remedies is the sole and exclusive licensee of DRY Citrasate® (Patented) (DRYalysate®) product in India, Bangladesh, Srilanka, Nepal, Bhutan, and Pakistan under license from Advanced Renal Technologies Inc., (ART) Washington, U.S.A.

What is citrate?

Citrate is a natural metabolite, which is a source of cellular energy, providing buffering capacity to the patient. Citrate is an intermediate in the citric acid cycle and is widely used in the food and drug industry because of its buffering, anticoagulant and antioxidant capacities.

Why citrate in dialysis?

An acid is required in bicarbonate dialysis to avoid insoluble calcium and magnesium precipitation. Acetic acid is commonly used at a concentration up to one hundred times higher than normal plasma acetate levels.

Body gain of acetate is particularly high in convective treatments. This results in a substantial increase in plasma acetate which may promote hemodynamic instability, inflammation and acidosis.

Citric acid has been proposed as an alternative dialysis buffer due to its anticoagulant, anti-inflammatory and anti-oxidant properties.

Proven & documented benefit of “DRY CITRASATE®”
  • Reduces metabolic acidosis.
  • Increases reuse of Dialyzers.
  • Improves dose of Dialysis
  • Heparin can be reduced up to 55%.
  • Enables heparin-free Dialysis of patients with anti-bodies to heparin(HIT) or those who are allergic to heparin .
  • Enables heparin-free Dialysis of patients with acute renal failure who are at risk of bleeding.
  • Improves treatment to patients who are actively bleeding or who are at risk of hemorrhage.
  • Improves dialysis in patients who are “dialyzer clotters”
  • Improved acid – base status.
  • Less Thrombogenic dialysis.
  • Reduces inflammation.
  • Improves tolerance to treatment Improve operational efficiency.
Usage & other benefits
  • DRY CITRASATE® comes in powder form that can be mixed on-site as needed.
  • Its advantage is lower shipping and storage costs, since DRY CITRASATE® occupies approximately 28 times less space or 80% less space than liquid Acid Concentrate.
  • DRY CITRASATE® is packed in convenient pouches that can be reconstituted in the dialysis unit to prepare 10 liters and 50 liters of Acid Concentrate ready to be used.
  • There is no change in treatment routine or equipment required to use.
  • Switching to DRY CITRASATE® Dialysate is simple. No alterations in the dialysis machine are required.
  • Patients and staff will see no difference in treatment procedures. To them, the conversion is "transparent" and convenient.
  • There is no staff training needed before converting to SHIFA's DRY CITRASATE® products.
  • No special blood tests are needed when doing Citrate Dialysis.
  • There is no additional patient or system monitoring needed beyond that normally employed in treatment with standard dialysate formulations.

FAQs

Is citrate Dialysate the same as regional citrate anticoagulation?

No, Performing citrate dialysis is no different operationally than doing regular dialysis. There is no regional infusion of citric acid employed. “it’s all in the Dialysate”.

Is it necessary to do continuous calcium infusions into the venous blood, as is done for regional citrate anticoagulation, in order to avoid problems associated with hypocalcemia ?

No, Calcium binding by Dialysate citrate is so small that no significant alteration in calcium occurs during dialysis the citrate content of the Dialysate is only 2.4mEq/L.

How does citrate Dialysate provide noted patient benefits.

As you know, citric acid is an anticoagulant. Its presence in the Dialysate is only 2.4mEq/L concentration provides same anticoagulation effects in the dialyzer and venous blood line that is quickly neutralized upon reentry into the systemic circulation.

Is it necessary to check clotting times when citrate Dialysate is used?

No.

Is there reason to be concerned about the bleeding risk , hypocalcemia, or hypomagnenesemia when treating patients with citrate Dialysate?

No, because the concentration of citrate in the Dialysate is well below the level needed to produce anticoagulation of the patient’s blood , there is risk of bleeding or low blood mineral levels from the citrate use .

Are Citrasate R and DRY-Citrasate cleared for clinical use by FDA?

Yes.

How do I adapt my present dialysis system to allow the use of citrasate or dry citrasate ?

You don’t need to adapt your system to the new Dialysate formulation. No change are necessary. Citrasate concentration is available in all standard concentration and formulation. You simply pour it into your standard A concenratate container and attach it to your dialysis system as you always do. If you prefer to mix A concentrate from powder, DRY- Citrasate is available for this purpose, and it can be mixed in your facility to make concentrate.

What steps are necessary before citrate dialysis can be started?

Both Citrasate and DRY Citrasate and dry Citrasate may be used in existing dialysis systems without altering them. Also there is no additional patients or system monitoring needed beyond that normally employed in treatment with standard Dialysate formulation consequently no staff training is necessary for the conversion to citrate Dialysate.

Can Citrate Dialysate be “spiked” with potassium or calcium?

Yes, It can be spiked just as you do with traditional Dialysate concentrate.