Colloids in Severe Trauma
Condition: Abdominal Hypertension; Abdominal Compartment Syndrome; Severe Trauma
MeSH terms: Compartment Syndromes; Intra-Abdominal Hypertension; Hypertension; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    


Intervention name(s): tetrastarch (Voluven)
Intervention type(s): Drug
Intervention description(s): Goals directed volume therapy for severe trauma resuscitation
Other intervention name(s): Voluven
Intervention MeSH terms: Hydroxyethyl Starch Derivatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: trauma resuscitation; abdominal hypertension; abdominal compartment syndrome