(Reuters Health) – Restricting intravenous fluids in ICU patients with septic shock does not lower the 90-day death rate, a large European study of 1,554 adults concludes.
Little hard information exists on the best volume of IV fluid to use in patients with septic shock, a leading cause of death.
There’s evidence that higher volumes are harmful because they might injure the kidney, produce respiratory failure or pose a higher risk of death. But it’s not clear that lower volumes work any better.
“The use has been liberal as recommended in international guidelines. But over the last years, increasing concern about harmful effects of fluid overload have resulted in more restrictive use by many clinicians,” coauthor Professor Anders Perner of Rigshospitalet in Copenhagen told Reuters Health in an email.
The results of the new study, known as CLASSIC, “may reassure clinicians that fluid volumes within the range tested appear to be safe.”
Half the patients were put in the restrictive-fluid group where they could only get IV fluid — 250 to 500 ml of saline or buffered solutions — if the patient had severe hypoperfusion, there were documented fluid losses that needed to be replaced, the patient was dehydrated or had an electrolyte deficiency, or to make sure the patient got a total daily fluid intake of 1 liter.
Patients in the standard care group had no limit on their IV intake.
Ultimately, after 90 days, patients in the restrictive-fluid group had received a median of 1,798 ml of IV fluid versus 3,811 ml in the control group. The mean intakes were 3,414 ml and 5,275 ml, respectively.
Total fluid volumes over that period were a median of 10,433 ml under fluid restriction rules and 12,747 ml in the standard-fluid group. The averages were 20,307 ml and 23,420 ml, respectively.
The 90-day death rates in the two groups were virtually identical: 42.3% with fluid restriction and 42.1% without.
Secondary outcomes, including serious adverse events, number of days alive without life support, and number of days alive and out of the hospital, were also not statistically different.
“Overall, the trial result was neutral, but in patients on mechanical ventilation, fluid restriction may have been beneficial. But in those not ventilated, it may have been harmful. These hypotheses should be tested in new trials,” said Dr. Perner.
Results of the trial were presented at the Critical Care Reviews annual meeting in Belfast and published online by the New England Journal of Medicine. The Novo Nordisk Foundation financed the test.
“We excluded patients with bleeding or burn injury. These patients may benefit from higher fluid volumes,” Dr. Perner said. “Also, some clinicians may individualize fluid input using predictive tools, the effect of which we did not assess in the trial.”
“It is vital for these patients to have these treatments improved because 40% still die within three months,” he said.
SOURCE: https://bit.ly/3HiV3wo The New England Journal of Medicine, online June 17, 2022.
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