The top 10 trials of the recent past are an interesting bunch highlighting some of the best and worst of evidence-based medicine. While they might not be all you need to know, they are some of what you need to know. Some are practice changing, some introduce new treatment paradigms that may change the way we practice in the near future. Sepsis trials, oxygen therapy in various forms, miracle cures, delirium-o-lysis, levosimendan, angiotensin-II, tranexamic acid, and decompressive craniectomy all feature. Anyone who doesn't think that the literature is interesting is bonkers.
33. dependentneed a minder
Independent but with some
physical or mental disability
Able to resume usual
activities but some probs
No problems
34. For every 100 patients treated
with surgical intent there were
22 more survivors,
5 were vegetative (23%), 4 were
dependent (18%), & 13 were
categorised as having severe
upper disability or better (59%)
Before and after study 47 patients with severe sepsis or septic shock and a PCT>2ng/ml
The hospital mortality was 8.5% (4 of 47) in the treatment group compared to 40.4% (19 of 47) in the control group (p<0.001).
During the treatment period consecutive patients with a primary admitting diagnosis of severe sepsis or septic shock and a PCT > 2 ng/ml were treated with intravenous vitamin C (1.5 gm q 6 hourly for 4 days or until ICU discharge), hydrocortisone (50 mg q 6 hourly for 7 days or until ICU discharge followed by a taper over 3 days) as well as intravenous thiamine (200 mg q 12 hourly for 4 days or until ICU discharge). The vitamin C was administered as an infusion over 30 to 60 minutes and mixed in a 100ml solution of either dextrose 5% in water (D5W) or normal saline. Intravenous thiamine was given as a piggyback in 50 ml of either D5W or normal saline and was administered as a 30- minute infusion.
Unblinded
Lack of internal validity – small sample size
Lack of external validity
To avoid the Linus Pauling trap, pragmatic multicenter trials are needed to confirm this benefit and to exclude unforeseen harm as was seen in previous sepsis trials using promising drugs.
Randomised to continue face mask CPAP or helmet CPAP.
Primary end point intubation: The intubation rate was 61.5% in the face mask group and 18.2% in the helmet group (absolute difference, −43.3%; 95% CI, −62.4% to −24.3%; P < .001)
Primary end point duration of mechanical ventilation
Eligible patients were 18 years of age or older and had vasodilatory shock despite intravenous volume resuscitation with at least 25 ml per kilogram of body weight over the previous 24 hours and the administration of high-dose vasopressors. We defined vasodilatory shock as a cardiac
index of greater than 2.3 liters per minute per square meter or as central venous oxygen saturation of greater than 70% coupled with central
venous pressure of more than 8 mm Hg, with a mean arterial pressure between 55 and 70 mm Hg. We defined high-dose vasopressors as more than 0.2 μg of norepinephrine per kilogram per minute, or the equivalent dose of another vasopressor (Table S1 in the Supplementary Appendix),12 for at least 6 hours but no longer than 48 hours. Eligible participants also had an indwelling bladder catheter and arterial catheter. We excluded patients who had burns covering more than 20% of the total body-surface area, acute coronary syndrome, bronchospasm, liver failure, mesenteric ischemia, active bleeding, abdominal aortic aneurysm, or an absolute neutrophil count of less than 1000 per cubic millimeter or who were receiving venoarterial extracorporeal membrane oxygenation or treatment with high-dose glucocorticoids.