News: Press Release
News: Press Release
Resuscitation fluid is associated with increased death and kidney failure; researchers say its use is not warranted
A new study shows the use of corn-based hydroxyethyl starches (HES), the most common blood volume expanders used to resuscitate critically ill patients with low blood pressure, may be doing more harm than good.
A team of researchers led by Dr. Ryan Zarychanski at the George and Fay Yee Centre for Healthcare Innovation (CHI) at the University of Manitoba have published a potentially practice-changing study this week in the prestigious Journal of the American Medical Association (JAMA).
Their study strongly discourages the use of HES after findings showed a higher mortality rate in people who received starch solutions compared with those treated with other products.
The research team based in Winnipeg, Canada, examined 38 clinical trials of HES solutions used for acute fluid resuscitation. These trials involved 10,880 patients from around the world and included the products that were the newest and reported to be the safest. Combining all of these data using a statistical method called meta-analysis, they found that mortality and kidney failure were increased in patients who received these solutions.
Zarychanski explains that data showing increased mortality may have been discovered earlier if not for previously published studies conducted by a German investigator which were later retracted because of scientific misconduct (evidence of data fabrication and failure to acquire research ethics approval). When these studies were excluded, the researchers observed a clear and significant increase in death in people who received hydroxyethyl starch and no indication that the new solutions were safe, despite published reports and commonly held beliefs.
To reduce the medical community’s reliance on human blood products, potential alternatives were developed and introduced into clinical practice. Several of these products, including HES, have been found to cause harm, prompting restrictions in their use or withdrawal from the market.
“The production of risk-free synthetic alternatives to human blood components have not been as successful as initially anticipated,” says Zarychanski.
Zarychanski, in the University Of Manitoba Faculty Of Medicine’s department of internal medicine, a critical care physician and hematologist at CancerCare Manitoba, notes: “Our findings should prompt physicians to reconsider their decision to use hydroxyethyl starch when resuscitating patients. The results are also likely to motivate hospitals to consider the appropriateness of these solutions on institutional formularies, and will provide further rationale for regulatory agencies to re-examine current licensing of these products.”
He explains that HES became part of standard care without properly conducted studies designed to assess relevant measures of patient safety such as kidney function or death. These important studies have only recently been conducted, and were included in the analyses done by Zarychanski and his team.
Research team member Dr. Alexis Turgeon, a critical care physician and clinician-scientist from the CHU de Québec Research Center at Université Laval in Québec City, explains: “New treatments or technologies, such as HES, may become part of standard medical practice, even without evidence to suggest they improve clinical outcomes such as mortality or morbidity improve, or without comprehensive safety data. We, as physicians, have to be cautious when implementing therapies that may make sense, but have not showed clear clinical benefit.”
Additional support for this research study was provided by the Winnipeg Regional Health Authority (WRHA) and CancerCare Manitoba.
The George and Fay Yee Centre for Healthcare Innovation, established as a partnership between the University of Manitoba and the Winnipeg Regional Health Authority, brings together leaders and practitioners from all disciplines in academia and practice to ensure that the latest research and evidence are translated into improvements to care and outcomes for patients and citizens of Manitoba. The goal of the CHI is to challenge and innovate the delivery of healthcare in Manitoba.