The response of human volunteers to rear-end impacts: the effect of head restraint properties.

STUDY DESIGN: Human volunteers were subjected to a rear-end impact while sitting on a standard automobile seat, and sagittal plane kinematic responses were quantified. The effect of changing head restraint properties was determined by use of a repeated measures design. OBJECTIVE: To determine the forces acting, and relative motions resulting, on volunteers in a rear-end impact and the effect of head restraint properties. SUMMARY OF BACKGROUND DATA: In several recent studies of the kinematics of the cervical spine during rear-end impact, a forward thrust to the lower cervical spine was produced, and a transient S shape of the spine resulted while the head remained upright during the initial phase of the impact. This may result in nonphysiologic intervertebral motions and tissue strains. METHODS: Nineteen automobile seats were first tested, and a modified head restraint was designed. Each volunteer sitting on a standard vehicle seat was subjected to an impact pulse of 3g with a 4-kph speed change. Testing was performed first with the modified head restraint, then again after replacement by the head restraint that came with the seat. Kinematic responses were compared for both head restraints by use of a repeated measures analysis of variance. RESULTS: There was a measurable time difference between peak chest and peak head accelerations, which resulted in the chest being thrust forward by the seat back before the head was thrust forward by the head restraint. The modified head restraint significantly reduced the contact time difference and therefore decreased the relative chest-to-head forward motion. CONCLUSIONS: Volunteers seated on a standard automobile seat demonstrated differential sagittal plane motion between the chest and head. It is possible to significantly decrease the relative chest-to-head motion by altering the characteristics of the head restraint.

Safety of intravenous gadolinium (Gd-BOPTA) infusion in patients with renal insufficiency.

The safety of gadolinium (Gd-benzyloxypropionictetra-acetate [BOPTA] dimeglumine) infusion was evaluated in 32 patients with severe or moderate chronic renal failure in a prospective, randomized, double-blind, placebo-controlled study. Renal failure was defined as severe if creatinine clearance was between 10 and 29 mL/min, and as moderate if creatinine clearance was between 30 and 60 mL/min. Serum creatinine level and 24-hour urine samples for creatinine clearance were followed up serially for 7 days after the administration of either gadolinium (Gd-BOPTA dimeglumine), 0.2 mmol/kg, or a saline infusion. No patient experienced a significant change in renal function, defined as an increase in serum creatinine level greater than 0.5 mg/dL more than baseline, and no patient required hospitalization or dialysis during the study period. Gadolinium (Gd-BOPTA dimeglumine) appears to be well tolerated in patients with moderate to severe renal failure.

Safety and pharmacokinetic profile of gadobenate dimeglumine in subjects with renal impairment.

RATIONALE AND OBJECTIVES: To determine the safety and pharmacokinetics of gadobenate dimeglumine in a group of subjects with moderate or severe renal impairment. METHODS: The safety and pharmacokinetic profile of gadobenate dimeglumine, a gadolinium (Gd3+) chelate complex in development as a contrast agent for MRI, were evaluated in a placebo-controlled, double-blind, multicenter trial. Subjects with moderate or severe renal impairment (creatinine clearances of 31 to 60 or 10 to 30 mL/min, respectively) received a 0.2-mmol/kg intravenous bolus of Gd3+ or saline placebo. Blood samples (up to 72 hours) and urine and fecal samples (up to 216 hours) were assayed for total Gd3+ content by inductively coupled plasma atomic emission spectroscopy. Gd3+ blood concentration/time data were analyzed nonparametrically and parametrically using the software program WinNonlin VI.1. RESULTS: Mean (SD) values for Gd3+ area under the curve, blood clearance, steady-state volume of distribution, renal clearance, and creatinine clearance for the moderate group were 862 (392) micrograms.h/mL, 56 (25) mL/min, 21 (5) L, 47 (23) mL/min, and 46 (16) mL/min. Values for the severe group were 1347 (366) micrograms.h/mL, 31 (7) mL/min, 19 (6) L, 22 (7) mL/min, and 21 (8) mL/min. No Gd(3+)-related adverse events occurred. Mean values for Gd3+ recovery in urine and feces for moderate and severe groups were 74% and 6%, and 69% and 8% of the dose, respectively. Linear regression analysis demonstrated a significant relation between the level of renal function and blood clearance of Gd3+. CONCLUSIONS: Although mean blood clearance and renal clearance values progressively declined with increasing degree of renal impairment, based on the safety profile and the fact that the administered dose was double the standard dose used for MRI purposes, there appears to be no need for dose reduction in this population.