The Toronto prehospital hypertonic resuscitation-head injury and multi organ dysfunction trial (TOPHR HIT) - Methods and data collection tools

<p>Abstract</p> <p>Background</p> <p>Clinical trials evaluating the use of hypertonic saline in the treatment of hypovolemia and head trauma suggest no survival superiority over normal saline; however subgroup analyses suggest there may be a reduction in the inflammatory response and multiorgan failure which may lead to better survival and enhanced neurocognitive function. We describe a feasibility study of randomizing head injured patients to hypertonic saline and dextran vs. normal saline administration in the out of hospital setting.</p> <p>Methods/Design</p> <p>This feasibility study employs a randomized, placebo-controlled design evaluating normal saline compared with a single dose of 250 ml of 7.5% hypertonic saline in 6% dextran 70 in the management of traumatic brain injuries. The primary feasibility endpoints of the trial were: 1) baseline survival rates for the treatment and control group to aid in the design of a definitive multicentre trial, 2) randomization compliance rate, 3) ease of protocol implementation in the out-of-hospital setting, and 4) adverse event rate of HSD infusion.</p> <p>The secondary objectives include measuring the effect of HSD in modulating the immuno-inflammatory response to severe head injury and its effect on modulating the release of neuro-biomarkers into serum; evaluating the role of serum neuro-biomarkers in predicting patient outcome and clinical response to HSD intervention; evaluating effects of HSD on brain atrophy post-injury and neurocognitive and neuropsychological outcomes.</p> <p>Discussion</p> <p>We anticipate three aspects of the trial will present challenges to trial success; ethical demands associated with a waiver of consent trial, challenging follow up and comprehensive accurate timely data collection of patient identifiers and clinical or laboratory values. In addition all the data collection tools had to be derived de novo as none existed in the literature.</p> <p>Trial registration number</p> <p>NCT00878631</p

Systolic pressures in the extremities of man with special reference to the toes

Systolic pressures have been studied extensively in the fingers but not in the toes. We measured systolic pressures in the toes, fingers, ankles, and wrists of young normal subjects during body heating and cooling. Systolic end points were determined during deflation of pneumatic cuffs by detecting either the appearance of oxyhemoglobin in the skin using a spectroscope, or the increase in the volume of the part using a strain gauge plethysmograph. Toe and finger pressures were higher during vasoconstriction than during vasodilatation (p &lt; 0.001), whereas the ankle-to-toe and wrist-to-finger gradients were higher during vasodilatation (p &lt; 0.005), These changes in pressures and gradients with change in vasomotor state are probably due to alterations in flow through the arteries of the hand and foot and the associated changes in the utilization of pressure energy. Finger pressures were higher than toe pressures during both vasomotor states (p &lt; 0.025). This was only partly explained by the difference in hydrostatic pressure (toes higher than fingers with respect to heart in supine position). The tendency for gangrene to develop in the toes may be related in part to their lower pressures. </jats:p