Use of Pentastarch Solution in the Treatment of Patients with Hemorrhagic Hypovolemia: Randomized Phase II Study in the Emergency Room

Abstract

This study evaluates the hemodynamic effects of the administration of 10% pentastarch solution (PS) during the initial treatment of hypovolemia in trauma patients. This prospective randomized phase II study included trauma patients admitted to the emergency room with hemorrhagic hypovolemia: systolic blood pressure (SBP) < 90 mmHg. Upon admission, the patients were randomized to receive 10% PS (n = 12) or isotonic 0.9% NaCl solution (IS) (n = 11), infused intravenously in 250-ml boluses, repeated until SBP > 100 mmHg. Blood pressure, infused volumes necessary to maintain SBP, and overall survival rates were determined and compared between groups. SBP increased significantly following either IS (from 64.4 +/- 9.2 mmHg to 111.1 +/- 6.3 mmHg), or PS (from 63.7 +/- 10.6 mmHg to 108.1 +/- 9.8 mmHg) when compared to admission values (p < 0.05). Endovenous volumes infused were greater (p = 0.001) in IS patients (1420 +/- 298 ml) than in PS patients (356 +/- 64 ml). No blood was transfused into PS patients, compared to 370 +/- 140 ml of red blood cells transfused into IS patients (p = 0.015). Mortality rates were similar in the two groups (p = 0.725). We concluded that PS is a safe, efficient method for inducing hemodynamic recovery of hypovolemic trauma patients, with a clear reduction in the intravenous volumes required for acute resuscitation.

Renal Outcomes Following Hydroxyethyl Starch Resuscitation: A Meta-Analysis of Randomised Trials

“…Twenty-one trials were published in peer-reviewed journals, and 1 was published in abstract form 31. Twenty trials were reported in English-language journals,7,8,18,19,30-45 1 was in French46 and 1 was in German 47. Five trials were conducted in North America,19,30,40,42,44 16 in Europe7,8,18,31-39,41,43,46,47 and 1 in South America 45.…”

“…Twenty trials were reported in English-language journals,7,8,18,19,30-45 1 was in French46 and 1 was in German 47. Five trials were conducted in North America,19,30,40,42,44 16 in Europe7,8,18,31-39,41,43,46,47 and 1 in South America 45. Four trials received grant funding from manufacturers of HES,18,19,42,44 2 received government support,7,41 and 16 trials reported no funding source 8,30-40,43,45-47…”

“…Eight trials enrolled patients with sepsis, severe sepsis or septic shock but no trauma,7,18,19,38,40,41,43,44 6 enrolled patients with trauma,31,32,37,42,45,46 5 enrolled patients with trauma or sepsis,33-36,39 and 1 enrolled patients with “hypovolemic shock”;30 1 study did not report the type of critically ill patients who formed the study population 47. One trial involved organ donors with brain death, who were randomly assigned to receive either HES or gelatin;8 in that study, the final unit of analysis was number of transplanted kidneys.…”

“…18,19,30,42,45 Two trials included pentoxifylline as a third-arm comparator, but these arms were not included in this systematic review because pentoxifylline is not used for resuscitation 37,38. Six different HES fluids, varying by molecular weight and molar substitution, were represented.…”

“…Twelve protocols involved administration of HES within the first 24 hours after presentation 8,19,30-32,40-42,44-47. The total amount of study fluid administered differed considerably among the trials; in particular, the mean volume of HES given varied from 364 mL (standard deviation [SD] 64)45 to 5350 mL (SD 650) 38…”