This multicenter prospective randomized double-blind study evaluated the safety and the efficacy of 6% HES 130/0.4 in saline compared to 0.9% saline alone for fluid resuscitation in an heterogenous population of 7000 intensive care unit patients.
Ninety-day mortality, the primary outcome of the study, was not different between the two fluid resuscitation regimens. Mortality was also not different in six predefined subgroups that included presence of acute kidney injury, sepsis, trauma or traumatic brain injury.
Although the incidence of being at risk for renal failure was not different between the two groups, more patients having received HES 130/0.4 were treated with renal replacement therapy. Days on renal replacement therapy were not different between the two groups.
The incidence of new cardiovascular failure was lower, and the incidence of new hepatic failure higher, in the HES group compared to the saline group.
The incidence of serious adverse events was not different between groups, but the incidence of pruritus and skin rash was more frequent in the HES group.
Regarding efficacy, the HES group received less study fluid than the saline group during the first 4 days, although the difference between the two groups was not clincally relevant. However, the mean volume of fluid administered over these 4 days was quite low for patients requiring fluid resuscitation. One may wonder if the patients studied were truly hypovolemic as they presented a normal heart rate, a normal mean arterial pressure and a central venous pressure around 9 mm Hg prior to randomization.
Overall, the results of this study indicate that HES 130/0.4 does not confer a clinical benefit over isotonic saline in an heterogeneous population of ICU patients that are not clearly hypovolemic. The interest of one or another specific fluid in a more homogeneous population remains to be evaluated.
– Philippe Van der Linden