Postoperative Morbidity Clinical Trial
Official title:
Fluid Loading in Abdominal Surgery: Saline Versus Hydroxyethyl Starch: A Double-blinded Multicenter Prospective Randomized Trial (FLASH Study)
The primary purpose of the study is to evaluate whether the type of fluid (0.9% saline or 6% Hydroxyethyl starch 130/0.4) in the context of an individualized goal-directed fluid therapy is associated with a difference in morbidity and mortality within the first 14 days in patients at moderate-to-high risk of postoperative complications after abdominal surgery.
Fluid administration is the mainstay treatment for suspected hypovolemia during surgery, but
the effects of different crystalloid and colloid solutions on outcome remain poorly explored
in surgical patients.
Two recent international multicenter studies (6S and CHEST studies) have shown that, compared
to crystalloid solutions, the use of hydroxyethyl starch (HES) could be responsible for
higher morbidity, especially renal failure, and mortality in ICU patients, thus leading to a
recent restriction of their range of indications.
In contrast, in surgical patients, recent meta-analyses have concluded on the absence of
difference in terms of mortality and postoperative renal failure between crystalloids and
latest generation HES. Excessive fluid administration during surgery is associated with
increased risk of postoperative morbidity, including renal dysfunction and mortality. It has
been suggested that, compared with the volume-restoring effects of colloids, crystalloid use
may require the administration of higher fluid volumes, which may contribute to poorer
outcomes. In the surgical context, clinical trials and meta-analyses have shown that
individualized goal-direct fluid administration can reduce postoperative morbidity. Although
most GDT studies have used colloid solutions for fluid loading, the effects of the type of
fluids are currently unknown and crystalloids are proposed for first-line therapy.
The proposed Flash multicenter study will be conducted to assess if the use of HES or
crystalloid solutions during an individualized GDT contribute to outcome differences in
patients at moderate-to-high risk of postoperative complications after abdominal surgery. As
these fluids are widely used during surgery and because of current concerns about the risks
related to the use of HES-based products in ICU patients, the trial will provide important
data to clinicians involved in perioperative care.
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