The presence of citrate in the fluid of renal dialysis, could be deleterious to the health of patients
According to a study conducted by doctors of the hospital Pitié Salpêtrière (AP-HP) and Inserm researchers, people dialysis with this type of fluid would have an increased risk of 40% to die prematurely compared to the other patients. The study – whose results were revealed on Wednesday by The World – has not yet been published or submitted to scientific expertise. However, an emergency meeting “with all stakeholders” was held at the Agency of the drug (MSNA) on Wednesday morning.47. .000 people with dialysis FranceEn France, nearly 47,000 people with chronic kidney failure are currently living through dialysis, according to the latest figures from the Agency of biomedicine. Three to four times per week, they should carry out sessions of four hours, which allow to eliminate the toxins accumulating in the body. The blood is placed in contact with the dialysate, a fluid that acts as a purifier and which, at the same time, brings to the blood minerals. For some of these minerals remain soluble in water, was added to the mixture a small dose of a substance responsible for the separate. This may include citric acid, hydrochloric acid, acetic acid or citrate. The substance then enters the body, without that its future is well known. Currently, more than 20% of patients are treated with a dialysate citrate, according to The World. But this type of dialysate is the last to arrive on the market in 2012.
“We wanted to know if some dialysats offered advantages for the patients, especially the more recent,” says Dr. . Lucile Mercadal, a nephrologist at the hospital of the Pitié-Salpêtrière hospital. “We have observed that hydrochloric acid was an advantage.
However, we did not expect to find a deleterious effect of citrate. “There will be more deaths before the heurePour perform their study, Dr. . Mercadel and his team have used the data of the register R. . E.
. I. . N (network of epidemiology and information in nephrology), which lists all of the dialysis patients since 2002.
Then they were cross-checked with the data of sale of 7 million of pockets, as provided by the industrial, centre by centre.
On the 25,000 patients seen, 8,000 were under dialysis in citrate. “We have noticed a larger number of deaths before the hour in this group, compared to the group of patients treated with dialysats more classic,” says the nephrologist.
The results, presented in early October at the congress of the francophone Society of nephrology, dialysis and transplantation (SFNDT), have not failed to alert certain groups of patients.
In the course of the month of November, so they decided to notify the Agency of the drug.
What had not made the Dr.
. Mercadel and his team, for reasons of scientific integrity. “There are steps to follow,” she explains. “We wanted to do things in the order: first submit our study to a scientific evaluation and to publish it, and then communicate.
But I understand that patients want to see apply a precautionary principle. “A health warning?On the other hand, the doctors had quickly made contact with the manufacturers concerned, shortly after obtaining their results. “We thought they would be more active, but they have not responded, considering that the study had limitations,” says Dr. . Mercadal. The specialist readily acknowledges, given the large number of factors which come into play in the occurrence of a death.
Because a question arises: is the citrate it is the only responsible for the excess mortality found? “We are well aware of the limits and qualities of our work that we have done honestly.
But we get a very significant result. It is completely biased, either it is supported and in this case, it is a health warning. “For his part, the MAN is surprised that no information has been wound up, “neither by industry, nor by the authors of the study” since the congress in October.
“As soon as a new fact of this type is known, we must be informed,” said a member of the Agency. “We’re not going to wait for the study to be published in order to take measures if there is a health issue”.
The meeting of 5 December could allow to see more clearly.