Abdominal Compartment Syndrome Clinical Trial
Official title:
Colloids in Severe Trauma: A Multi-Center Pilot Study of "Crystalloid Only" or "Crystalloid + Colloid" Volume Resuscitation in Trauma Patients (CIST)
Background:
Fluid resuscitation is a cornerstone of the initial management of the critically injured
trauma patient yet there are numerous controversies surrounding this very common practice.
As a result, these controversies have been the subject of numerous clinical trials,
evidence-based guidelines and systematic reviews.
With the publication of the landmark SAFE Study the equipoise between the 2 treatments
(which were representative solutions for colloid and crystalloids respectively), 4% albumin
and saline, was established. This has however been brought into further doubt by the paucity
of data on the use of hydroxyethylstarches (HES), which are less costly and have less side
effects than albumin, in trauma. More recent findings by Gruen and colleagues have shown
that as much as 5% of all trauma deaths are the result of fluid overload based on the North
American fluid management model for trauma (pure crystalloid fluid management).
A meta-analysis done by Kern and Shoemaker found that supranormal fluid resuscitation with
crystalloids is beneficial when given before the onset of organ failure in critically ill
surgical patients. Balogh and colleagues found out that when supranormal fuid resuscitation
with crystalloids was applied to victims of severe trauma, this resulted in a statistically
significant increase in the incidence of mortality, multiple organ failure, intra-abdominal
hypertension (IAH) and abdominal compartment syndrome (ACS). More recently, Kirkpatrick and
colleagues reviewed and defined a 'secondary' ACS as a direct result of fluid resuscitation.
They concluded that "excess resuscitation with crystalloid fluids might be harming patients
and contributing to an increased occurrence of ACS."
This study will serve as a pilot to test the hypothesis that there will be significant
differences in clinical outcomes for patients with severe trauma treated with colloid (HES)
plus crystalloid and crystalloid only fluid management regimens, most notably the incidence
of IAH and ACS.
It is hoped that the hybrid colloid (HES) plus crystalloid fluid management regimen will
provide a means to avoid the untoward fluid overload and/or other complications of pure
crystalloid fluid management and the costs/complications of albumin administration.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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