According to a new study published in the New England Journal of Medicine (NEJM) on May 15th, 2016, the time of renal replacement therapy initiated for critically ill patients with acute kidney disease, early or late, has no significant difference in terms of resulting death rates.
The trial, supported by the Programme Hospitalier de Recherche Clinique National, and funded by the French Ministry of Health, was conducted in 31 intensive care units (ICUs) all over France. The Artificial Kidney Initiation in Kidney Injury (AKIKI) trial was approved by the ethics committee of the French Society of Intensive Care Medicine.
The trial was designed to be prospective, open-labeled and un-blinded in design.
All the participants were of 18 years of age or older with criteria for participation dependent upon laboratory abnormalities like pH below 7.15, blood urea nitrogen level higher than 40 mmol per liter, serum potassium concentration greater than 6 mmol per liter, and acute pulmonary edema.
During the period of September 2013-January 2016, 620 people with acute kidney disease were randomized into two groups. According to the study, the randomization was computer generated, with undisclosed size and stratification.
For the early group, intervention in the form of renal replacement therapy was performed within six hours of documentation of third stage acute kidney injury. In the delayed group, intervention was only made when one of the laboratory conditions was defined for selection developed, or either anuria or aliguria lasted for more than 72 hours of randomization. 49% of the patients in the delayed therapy group did not receive the intervention.
The intervention was discontinued to avert any side effects of the therapy if urine output increased over a certain limit set at the start of the study.
The patients were followed up till 60 days of randomization. The primary outcome was set as overall survival from randomization to death or day 60.
The Kaplan-Meier estimates for mortality at the day 60 for the early and delayed group were 48.5% and 49.7% respectively.
Researchers led by Stéphane Gaudry, MD, from the Hôpital Louis Mourier in Colombes, France, write, “Our trial involving critically ill patients with severe acute kidney injury, showed no significant difference in mortality with a strategy of delayed initiation as compared with early initiation of renal-replacement therapy.”
The writers, however, clarified that they did not suggest the ‘wait and see’ approach for any patients and careful monitoring should be advised before deciding to delay the therapy in patients with severe injuries. They also noted that in their trial, many patients recovered from acute kidney injury without any kind of renal therapeutic intervention.
Associated with high morbidity and mortality rates, acute renal failure is often seen as a common condition in patients residing in ICUs. Renal replacement therapy, a common method of management for the disease, has been studied extensively for clinical use. The timing of the therapy, however, is the subject of extensive debate as different results from studies have been seen over the years.
Two studies have found that people not receiving this therapy at all have high survival rates. One study has found that early initiated renal replacement therapy in patients with sepsis resulted in adverse health outcomes. However early initiation may allow for better control of electrolyte and fluid status along with prevention of complications like gastric hemorrhage and metabolic encephalopathy.
Renal replacement therapy is used for patients when kidneys cannot perform their normal functions. The therapy helps with blood filtering function of the kidneys. Techniques such as intermittent hemo-dialysis, continuous hemo-filtration and hemo-dialysis, and peritoneal dialysis can be used. Renal replacement therapy does not correct the primary issue causing the problem but rather performs the function of the kidneys instead.
According to the last 2008 surveillance report for dialysis in the US, the Centers for Disease Control and Prevention (CDC) revealed that 309,269 patients were treated for end stage renal disease in 2004 with help of dialysis.
Acute renal failure is defined as the sudden loss of kidney function that develops within the duration of seven days, characterized by the loss of the ability to excrete wastes, conserve electrolytes, maintain fluid balance, and concentrate urine. Decreased renal blood flow due to kidney damage, exposure to harmful substances, inflammation, or obstruction of urinary tract can be the likely causes of development for this particular condition. The disease can be fatal if clinical management interventions are not made.
Over the last 20 years, in the US, there has been a dramatic rise in the number of cases for the acute renal failure. The new numbers cannot be explained by the difference in newly developed definitions, standardized changes in serum creatinine, differences in coding and reimbursement, or increased availability of dialysis for the patients.
Acute renal failure is one of the most expensive conditions for treatment in United States. In 2011, 498,000 hospital stays amounted to nearly $4.7 billion in treatment costs.