A new technique to save the life of newborn babies. First on B39 now on the BBC.

Prof. Claudio Ronco
Prof. Claudio Ronco

 

The article below was offered to the South China Morning Post more than one year ago, but it was not deemed worth of publication. Last week the same news was broadcasted by the BBC and the Italian National Television RAI. Then it was picked by France Press and run by all the major newspapers around the world, including the SCMP. The circularity of truth…

 

Carpe Diem is a common Latin expression meaning ‘seize the day.’ Soon it will be also known as the acronym of a revolutionary equipment called CARPEDIEM (Cardio Renal Pediatric Dialysis Emergency machine) built by Professor Claudio Ronco, Director of the Department of Nephrology at the San Bortolo Hospital of Vicenza, Italy. This represents the first available treatment in the world for multiple organ failure in a neonate already successfully in operation. Professor Stuart Goldstein of the Cincinnati Children Hospital and professor Zaccaria Ricci from Rome Hospital of Bambin Gesù – two world famous experts in the field – have declared that this is a true miracle and very likely this machine will change the way of practicing medicine and managing the neonate in the years to come.

Professor Ronco has been visiting professors in several prestigious American university, Mount Sinai Hospital in New York, the George Washington University Hospital in Washington DC, The University of Virginia in Charlottesville.

 

Acute kidney injury may occur in neonates due to several causes, the most common one being an hemorrhagic shock due to a complicated delivery.

For many years the only treatment available was peritoneal dialysis, a therapy based on infusion and drainage of a sterile fluid into and from the abdominal cavity. The fluid is progressively loaded with the solutes not cleared by the failing kidney and then replaced with another batch of fresh fluid.

However, peritoneal dialysis has many complications and a very limited efficiency, especially in removing the excess of fluid that tend to accumulate in the infant that does not have adequate urine output.

In 1984, professor Ronco – a pioneer in the area of dialysis technology – developed a new technique called continuous arterio-venous hemofiltration for the neonate. He published a series of studies on four infants treated on a extracorporeal circuit in which blood was circulated through a permeable filter by the pressure gradient generated by their hearts. Already an expert in the adult technique and in bioengineering of hollow fiber hemodialyzers (filters for blood cleansing), professor Ronco became worldwide known in the field of pediatric hemofiltration thanks to his ingenious development of minifilters: a scaled down version of adult filters used for the artificial kidney technology. In the newborn it was fundamental to develop a tool with dimensions and volumes of priming extremely low: the neonate has approximately 300 ml of blood in his body. Even small shifts of this volume into the extra-corporeal circulation would create major hemodynamic derangements.

As a consequence of this pioneering experience arterio-venous hemofiltration in neonates has become a reality all over the world for the following years. Subsequently the technique in the adult was modified and specific machines with blood pumps were utilized to optimize the extracorporeal circuit. These machines however were proven inadequate for pediatric use, even in presence of customized circuits. In fact current equipment are mostly used off-label in patients with less than 15 Kg of body weight and are often useless in neonates or premature child. One of the major obstacles in fact is the small size of the catheter utilized on a tiny patient and the low accuracy of flow control in the blood circuit and fluid balance control of the dialysate circuit.

With this in mind, professor Ronco in 2008 undertook a new journey into this new field of infant medicine; a branch sorely lacking dedicated technology. The low incidence of the syndrome in neonates and the consequent low expected return of investment make this technology a low priority for the industry. Thus professor Ronco and a non-profit organization Called ‘Friends of the Kidney of Vicenza’ started a fund raising campaign to engage a team of experts capable of developing a miniaturized device for renal support in the neonate. Professor Ronco and his dedicated team created a prototype in a record time of 12 months. The machine was then manufactured by Medica Company, and placed on the market by Bellco (Mirandola-Italy). CARPEDIEM received the CE mark in 2012 and after a thorough testing in the International Renal Research Institute of Vicenza; the machine was on the market starting from June 2013.

Two pilot treatment have been carried out as a field test but finally on September 2013 the first complete extracorporeal support was started in the San Bortolo Hospital of Vicenza Italy on a neonate with a severe multiple organ dysfunction and oliguric kidney failure. 24-hour hemofiltration has been carried out for 15 days with stabilization of vital parameters and removal of fluid overload. Blood flow is 13 ml/min with a 4 French bilumen catheter and daily clearance is 2.2 liters (a volume exchange close to patient’s total body water). The baby developed a severe hiperbilirubinemia due to combined liver dysfunction and the hemofiltration treatment was then alternated with plasmapheresis with a modified CARPEDIEM circuit. The extracorporeal priming volume of the circuit is less than 20 ml, allowing maximal hemodynamic tolerance.

Today a newborn baby is under treatment with vital and metabolic parameters improving together with an increased diuresis, increasing volume of enteral nutrition and has been finally extubated. It is still unknown what will be the mid-long term outcome due to the many comorbid variables but before the CARPEDIEM, an inevitable deadly outcome would have occurred within a few days after birth. This is likely to be a new milestone in pediatric medicine.

 

 

 

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