November 15, 2012
Hydroxyethyl Starch or Saline for Fluid Resuscitation in Intensive Care.
What was the research question?
What is the safety and efficacy of 6% HES (130/0.4) as compared with 0.9% saline alone for fluid resuscitation in a heterogeneous population of adult patients treated in the ICU?
How did they do it?
A multicenter, prospective, blinded, parallel-group, randomized, controlled trial in 32 adult medical–surgical ICUs in Australia and New Zealand.
7000 critically ill patients were randomized in a 1:1 ratio to receive 6% HES 130/0.4 (hydroxyethyl starch) or 0.9% sodium chloride for all fluid resuscitation during ICU stay up till 90 days.
The primary outcome was death within 90 days.
Secondary outcomes included acute kidney injury and failure and treatment with renal-replacement therapy.
What did they find?
90-day mortality rate was not significantly different between the HES group and the saline group (18% versus 17%; P= 0.26).
There were no significant differences in subgroups that included sepsis, trauma, traumatic brain injury, severity of illness, or status of baseline renal functions.
Renal replacement therapy was used in the HES group at a significantly higher rate compared to the saline group (7.0% vs. 5.8%; p=0.04; NNH 83).
Renal injury was significantly higher in the HES group compared to the saline group (34.6% vs. 38.0%; P=0.005), and renal failure occurred in 10.4% and 9.2% of patients, respectively (P=0.12).
HES was associated with significantly more adverse events with pruritus and skin rash (4.6% vs. 3.3%, P=0.006).
What does it mean?
Resuscitation with HES was associated with higher rate of renal replacement therapy and acute kidney injury with higher adverse events compared to normal saline and critically ill patients but no significant difference in 90-day mortality.
HES should not be used in the ICU for resuscitation.