A multicenter, multi-sponsor series of trials with the principal researcher of Dr. Laura Dember (the principal sponsor of the study was the University of Pennsylvania) attempted to discern if longer hemodialysis sessions would prove a better therapy for patients. The other collaborating institutions include the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) [part of the National Institutes of Health (NIH)], Fresenius Medical Care of North America, Davita Clinical Research, and the National Center for Complementary and Integrative Health (NCCIH).
The study was described in the Journal of the American Society of Nephrology. Besides Dr. Dember, the other authors included Drs. Jesse Y. Hsu, Susan S. Ellenberg, Denise Cifelli, Rosemary Madigan, and J. Richard Landis (University of Pennsylvania); Eduardo Lacson, Michale Angeletti, Rebecca L Wingard, Christina Kahn,and Franklin W. Maddux (Fresenius Medical) ; Steven M. Brunelli, Amy Young, and Allen R. Nissenson (DaVita Medical); Alfred K. Cheung and Tom Greene (University of Utah); John T. Daugirdas (Illinois-Chicago); Csaba P. Kovesdy (Tennessee Health Center); Dana C. Miskulin (Tufts); Ravi I. Thadhani (Massachusetts General and Cedars-Sinai LA); Wolfgang Winkelmayer (Baylor) and Kevin C. Abbott (NIDDKD, NIH).
This TiME Study (Time to Reduce Mortality in ESRD) involved some 7035 patients, all undergoing dialysis that exceed 4.25 hours at some 266 clinics. (The current ‘normal’ dialysis duration is 3.5 hours.) The concept was to embed a trial during the routine administration of dialysis. The patients who agreed to join the study were not new to dialysis- they had to have been undergoing dialysis for at least 2 years prior to joining the study.
The primary outcome of the trial was death; secondary outcomes included hospitalization, and changes in the quality of life, among others. The groups with longer dialysis did not have any reduction in mortality or hospitalizations over the course of the trial. Obviously, the purpose of the trial was to improve the patients’ conditions- reduced hospitalizations and/or mortality. No definitive answers developed over the course of 1.1 years of the trial, which is why it was terminated.
It turns out the researchers feel that the only major finding claimed for this clinical trial was that on-site research personnel may no longer be needed for a large study population or for the acquisition of data. (When we effect clinical trials, our staff is on site at best one day a week; however we do collect all the data routinely as we monitor progress. Other clinical trials do employ full-time staff at centers to monitor progress and obtain data.)
Too bad. It would be great to improve the lives of those who need dialysis thrice weekly.
Yes, that would be good! Maybe continued research will find something that does work better.
We need to address mortality and quality of life issues- dialysis per se works well, but it’s those two issues.
So many people suffer from diabetes, even children. Do you think they will ever find a way to find a cure or other ways to control it besides long dialysis treatments?
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Diabetes leads one to kidney failure. And, dialysis doesn’t treat the diabetes. Right now, the best hope are the insulin pumps with monitors. Unless and until we allow stem cell development, Martha
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