Shock is the inadequate flow of fluid through the organs and tissues of the body that can lead to death. Examples of causes of shock are loss of blood, dilation of blood vessels or inadequate pumping of the heart. After shock occurs the tissues produce increased amounts of substances or mediators that cause tissue damage and make shock difficult to reverse such as nitric oxide (NO), tumor necrosis factor, platelet activating factor, prostaglandins or leukotrienes.
In addition, when blood or other currently available fluids are given to restore adequate flow some of the oxygen gets converted to toxic reactive oxygen species that can cause cell death. Thus, the very act of correcting hypovolemia or inadequate flow is a double-edged sword. To date no fluid used to restore flow in shock addresses this paradox.
Dr. Cuthbert Simpkins as a licensed physician and trauma surgeon, faced the grim reality of some patients dying in his operating room or the intensive care unit, even after their traumatic injuries had been repaired, due to a lack of a more effective resuscitation fluid.
One particular occasion, he was deeply troubled by the death of a 17-year-old girl who died due to the effects of hypovolemia in spite of the successful surgical repair of her injuries. This case and others like it drove him to study and experiment with several combinations and permutations of the then known resuscitation fluids. He hoped to find a fluid mix that would work in smaller volume and that would minimize the biochemical disruption caused by the combination of trauma and blood loss. The result of his work led to a colloidal fluid that appears in the animal model to be more effective and safer than other products. He initially named the colloidal fluid VIVACELLE (now referred to as VBI-1 and VBI-S).
The key component of VIVACELLE is a colloid made of soybean oil encapsulated by phospholipids. This thermodynamically stabilized spherical arrangement of molecules is called a nano-micelle. It is comprised entirely of biocompatible and metabolizable components. The use of nano-micelles as a colloid to raise the blood pressure in hypovolemic subjects is unprecedented. As with other colloidal volume expanders the lipid micelles in VIVACELLE produce a colloidal osmotic pressure that raises the lowered blood pressure and maintains it.
In addition, we have found that one of the properties of VIVACELLE is that it absorbs nitric oxide (NO), a gas produced in excess by the body during hypovolemic shock and that contributes significantly to the drop in blood pressure when volume is lost inside the blood vessels. Another favorable aspect of the NO absorption is that it is readily reversible so that NO can be released where in it is needed in the body.
Additional experiments revealed that the oxygen content of VIVACELLE is greater than other resuscitation fluids such as Ringer’s lactate. In comparison to Ringer’s lactate, the resuscitation fluid recommended by the American College of Surgeons, VIVACELLE improved survival in animal studies/experiments. In animal studies/experiments, in comparison to another colloid, albumin, VIVACELLE maintained improved blood pressure longer.
In animal studies/experiments, no complications with the use of VIVACELLE have been found. In contrast, the hetastarch-based resuscitation fluids such as Hextend and Voluven have recently been the subject of warnings from the FDA and the European Medicines Agency.