Hydroxyethyl starch - the importance of being earnest

Despite ongoing controversial expert discussions the European
Medicines Agency (EMA) recently recommended to suspend marketing
authorisations for hydroxyethyl starch. This comment critically
evaluates the line of arguments. Basically, the only indication for
a colloid is intravascular hypovolemia. Crystalloid use appears
reasonable to compensate ongoing extracellular losses beyond. In
the hemodynamically instable patient this leads to the distinction
between an initial resuscitation phase where colloids might be
indicated and a crystalloidal maintenance phase thereafter. It is
important to bear this in mind when reevaluating the studies the
EMA referred to in the context of its recent decision: i) VISEP
compared ringer's lactate to 10\% HES 200/0.5 in septic patients
and found an increased incidence of renal failure in HES receivers.
Unfortunately, study treatment was started only after initial
stabilization with HES, randomizing hemodynamically stable patients
into a rational (crystalloids) and an irrational (high dose starch
until ICU discharge) maintenance treatment. ii) 6S compared
ringer's acetate to 6\% HES 130/0.42 for fluid resuscitation in
septic patients and found an increased need of renal replacement
therapy and a higher mortality in the HES group. However, patients
of both groups were again randomized only after initial
stabilization with colloids, the actual comparison was, therefore,
again rational vs. irrational. Beyond that, the documentation is
partly fragmentary, leaving many important questions around the
fate of the patients unanswered. iii) CHEST randomized ICU patients
to receive saline or 6\% HES 130/0.4 for fluid resuscitation.
Actually, despite partly discussed in a different way, this trial
showed no relevant differences in outcome. In all, two studies
showed what happens to septic patients if starches are used in a
way we do not observe in daily practice. The third one actually
proves their safety. The benefit of perioperative goal-directed
preload optimization using starches is unquestioned. Taking these
informations into account, the recommendation of the EMA starches
to be generally dangerous remains mysterious and incomprehensible.
An authority being able to dictate behavior should stand clear from
oppressively ending a worldwide expert discussion and step back
into the role of the observer until science achieves an agreement.