Colloids in Severe Trauma (CIST)
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.
|Abdominal Hypertension Abdominal Compartment Syndrome Severe Trauma||Drug: tetrastarch (Voluven)||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Colloids in Severe Trauma: A Multi-Center Pilot Study of "Crystalloid Only" or "Crystalloid + Colloid" Volume Resuscitation in Trauma Patients (CIST)|
- Intraabdominal hypertension [ Time Frame: 30 days ]
- abdominal compartment syndrome [ Time Frame: 30 days ]
|Study Start Date:||May 2009|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
No Intervention: Crystalloid only
patients will receive crystalloid fluids only for volume therapy of severe trauma
Active Comparator: Colloid + Crystalloid arm
Goal directed volume therapy for severe trauma resuscitation
Drug: tetrastarch (Voluven)
Goals directed volume therapy for severe trauma resuscitation
Other Name: Voluven
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890383
|Jose Reyes Memorial Medical Center|
|Manila, Metro Manila, Philippines|
|East Avenue Medical Center|
|Quezon City, NCR, Philippines|
|Principal Investigator:||Rafael J Consunji, MD MPH||University of the Philippines|