BACKGROUND:
The objective of this study was to investigate the relationship between different
target levels of glucose and the clinical outcomes of patients undergoing cardiac
surgery with cardiopulmonary bypass.
METHODS:
We designed a prospective study in a university hospital where 109 consecutive patients
were enrolled during a six-month period. All patients were scheduled for open-heart
surgery requiring cardiopulmonary bypass. Patients were randomly allocated into two
groups. One group consisted of 55 patients and had a target glucose level of
80–130 mg/dl, while the other contained 54 patients and had a target glucose
level of 160–200 mg/dl. These parameters were controlled during surgery and
for 36 hours after surgery in the intensive care unit. Primary outcomes were clinical
outcomes, including time of mechanical ventilation, length of stay in the intensive care
unit, infection, hypoglycemia, renal or neurological dysfunction, blood transfusion and
length of stay in the hospital. The secondary outcome was a combined end-point
(mortality at 30 days, infection or length of stay in the intensive care unit of more
than 3 days). A p-value of <0.05 was considered significant.
RESULTS:
The anthropometric and clinical characteristics of the patients from each group were
similar, except for weight and body mass index. The mean glucose level during the
protocol period was 126.69 mg/dl in the treated group and 168.21 mg/dl in the control
group (p<0.0016). There were no differences between groups regarding
clinical outcomes, including the duration of mechanical ventilation, length of stay in
the intensive care unit, blood transfusion, postoperative infection, hypoglycemic event,
neurological dysfunction or 30-day mortality (p>0.05).
CONCLUSIONS:
In 109 patients undergoing cardiac surgery with cardiopulmonary bypass, both protocols
of glycemic control in an intraoperative setting and in the intensive care unit were
found to be safe, easily achieved and not to differentially affect clinical
outcomes.
A phase 1 double blind crossover comparison of a new benzodiazepine antagonist (Ro 15-3505) with Ro 15-1788 and placebo, in the reversal of sedative and psychophysiological effects of single IV doses of flunitrazepam (2 mg), was carried out in 12 normal volunteers. The antagonists were equally effective, leading to full reversal of all effects with a potency ratio of approximately 2.5 mg Ro 15-1788 for 1 mg Ro 15-3505. Inverse agonism, in the form of unpleasant feelings and symptoms, was reported by all subjects following Ro 15-3505 but none after Ro 15-1788. Adaptational phenomena such as acute tolerance and rebound of sedative effects of flunitrazepam were also detected and their potential implications are discussed.
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