01242019Thu
Last updateTue, 22 Jan 2019 4pm

Civil Hospital in Guadalajara starts groundbreaking trials for dialysis patients

New technology that could benefit individuals undergoing peritoneal dialysis is currently undergoing clinical testing at Guadalajara’s Civil Hospital.

pg11aDialysis keeps people alive when their kidneys are failing, by purifying their blood. In hemodialysis, your blood is put through a filter outside your body, cleaned, and then returned to you.

“While hemodialysis is most commonly used around the world, peritoneal dialysis is an excellent alternative and far less expensive,” said Dr. Margarita Ibarra of the Civil Hospital’s Nephrology Department.  “A big advantage is that most people can give themselves treatments at home or even at work or in a hotel.”

While only 12 percent of people with kidney failure in the United States use peritoneal dialysis, in Europe the figure is around 20 percent, and in Mexico it’s 80 percent.

One drawback to peritoneal dialysis is that it is commonly carried out in an environment far less antiseptic than that of a hospital, said Ibarra. “Every time the dialysis is carried out, the patient’s peritoneum is being exposed to the exterior environment. All this is happening at home without medical supervision and, therefore, infection is one of the principal complications that can occur.”

The Hospital Civil was recently contacted by Egyptian engineer Aly Elbadry, the founder of a company called Cloudcath, which has developed an innovative device to detect and prevent infections among users of peritoneal dialysis.  The clinical trial of the device at the Guadalajara’s hospital began in October 2018, and involves 150 patients. “So far,” he told me, “it has demonstrated excellent infection detection resolution.”

Elbadry explained that peritoneal dialysis patients currently are taught to look for signs of infection by inspecting the solution they are about to discard. If there is no infection, the solution should come out clear or transparent, he said. “When there is an infection, it has a milky-whitish color, it looks cloudy. This is due to the entrance of white blood cells in order to fight infection.”

Elbadry said it takes on average three to five days before this change in the solution is visible to the naked eye, at which point the patient should call a doctor to report a possible infection.

By now, however, it may be late and the infection will be difficult to treat with a simple antibiotic. Because of late detection, Elbadry told me, many patients end up hospitalized and have to have surgery to remove the catheter.

pg11b

He continued: “More than four percent of patients who end up going to the hospital because of a case of peritonitis end up dying. If the infection had been caught sooner, they could have taken a very simple antibiotic course that would probably have dealt with the infection without need for hospitalization.”

Elbadry’s method to resolve this problem was to create a piece of hardware that sits at the end of the drain line.

“Our device looks very much like the white Apple mouse,” he said. “Whenever drainage passes through it, information is uploaded in real time via a communication module to our cloud-based center. Our algorithm is able to instantly determine that there is a deviation in the data, indicating that this patient is in the early stage of developing an infection. In a word, we detect infections in six hours rather than five days.”

Elbadry said the name of the device, Cloudcath, refers both to the internet cloud and to the cloudy solution indicating infection.

After studying electrical engineering, Elbadry ended up at Stanford University, where he took a course called Biodesign Innovation. “It was an affiliation between the medical, engineering and business schools. We spent six months working with doctors and engineers, with me representing the business school, working basically on how to build commercially viable technology to solve healthcare issues. We chose to focus on peritoneal disease and dug very deeply into it to figure out everything about peritoneal dialysis, infections and the hospitalization rate and then tried to do something about it. And here we are now, a year and a half later, hopefully on our way to something good.”

The Cloudcath team at the Hospital Civil includes nine Guadalajara university students who are studying both biomedical and chemical engineering. All are working on rotating schedules, 14 hours a day, seven days a week. “They have learned to completely reassemble and rebuild our products, and are very familiar with the data acquisition technique,” said Elbadry. “They haven’t even graduated and yet they’re doing the work that a clinical research organization would formally do. Equally amazing is the medical team under Dr. Guillermo Garcia, chief of Nephrology, and I can’t begin to describe the contributions of Dr. Margarita Ibarra and Dr. Luz Alcantar, the lead nephrologists who find the patients for us, who make sure they meet all the criteria for the testing and who make sure a great team of nurses are delivering all the samples on time with all the specific requirements. All of this is very tough, continuous work and we were very lucky to find such talented people, all of them local.”

For more information, see Cloudcath.com.

No Comments Available