hydroxyethyl starch FDA warning

[BLADEMDA]

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Conclusions
Although the two groups were not perfectly matched, this pilot shows that fluid management based on SVV and SV optimization decreases wound infections. It also suggests that such a GD strategy may decrease postoperative organ dysfunction and resource utilization. However, this remains to be confirmed by a larger study.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3061666/

 

[KLPM]

Did he train in Germany? Those guys use that like water. Wonder if they are changing their practices based on this warning.

Did you guys get the email from voluven? They must be scared.

Maybe his name is Joachim.

 

[BLADEMDA]

European Body Calls for Halt to Marketing of Hydroxyethyl Starch




by AN Staff

A committee of the European Medicines Agency has called for a suspension of the marketing of infusible hydroxyethyl starch (HES), concluding that the clinical benefits of the products "no longer outweigh their risks."

The recommendation, from the agency's Pharmacovigilance Risk Assessment Committee (PRAC), comes on the heels of three recently published studies suggesting that the products increased the risk for kidney damage in patients with severe sepsis compared with crystalloid therapy. Two of those papers also found that HES solutions appeared to increase the risk for death in patients who received them.



"The PRAC was of the opinion that, when compared with crystalloids, patients treated with HES were at a greater risk of kidney injury requiring dialysis and had a greater risk of mortality. The PRAC also considered that the available data only showed a limited benefit of HES in hypovolemia, which did not justify its use considering the known risks. The PRAC therefore concluded that the marketing authorizations for these medicines be suspended," according to an agency statement.


The suspension, which has yet to be made official, would last "unless the marketing authorization holder can provide convincing data to identify a group of patients in whom the benefits of the medicines outweigh their risks," PRAC said.

 

[kazuma]

I haven't seen starches used since I was a med student on my anesthesia elective in early 2010.

We have starch solutions in our OR's but I've never given it nor have I heard of any other residents using it at my program. If a colloid is preferred over LR/plasmalyte then we usually use Albumin or blood products if indicated. It's anecdotal, but I usually see a mild to modest increase in BP when using 5% albumin and it seems to stay intravascular longer than crystalloid. The reported anti-inflammatory/antioxidant properties are an interesting potential benefit as well.

At $30-50/bottle it's quite a bit more expensive than crystalloid and it does have potential infection risks, so I usually use albumin as a last resort.

 

[BLADEMDA]

AlbuRx® 25, Albumin (Human) 25% solution is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been extremely reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses through alcohol fractionation and through heat treatment of the product in the final container for 10 hours at 60°C. Despite these measures, such products can still potentially transmit disease. A theoretical risk for transmission of Creutzfeldt-Jakob Disease (CJD) is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for Albumin (Human). There is also the possibility that unknown infectious agents may be present in such products. All infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to CSL Behring at 1-800-504-5434.

 

[ketap]

so, which albumin concentration would you recommend for resuscitation?
regards,ketap🙂