Randomized Controlled Trials

Apr 182011

Trouillet et al randomized patients requiring mechanical ventilation 4 days after cardiac surgery to either immediate perc-trach, or delayed percutaneous tracheostomy at 15 days. There were no differences in ventilator-free days at 60 days, nor in survival at 28, 60, or 90 days, nor in rates of VAP; however, the early-trach group had a lower [… read more]

Mar 202011

Hooman et al pooled 5 randomized trials with 112 patients, who had 184 episodes of elevated intracranial pressure. They concluded hypertonic saline is better at reducing ICP; but the relative-risk-for-ICP-control confidence interval was 1.0-1.3 and the mean ICP reduction included zero (-1.6 to 5.7 mm Hg). So, maybe. Crit Care Med 2011;39:554-559.

Mar 152011

Busse et al randomized 419 inner-city kids (age 6-20) with uncontrolled, skin-test-positive, mostly severe allergic asthma and IgE < 1,300 IU/mL to 60 weeks of omalizumab or placebo. The treated group had modest improvements: ~1 fewer day of symptoms per month and a 5% absolute reduction in hospitalizations (1.5% vs 6.3%); 18% fewer of them [… read more]

Mar 112011

Roquilly et ses amis francais randomized 150 critically ill victims of severe French trauma to hydrocortisone or placebo for 7 days. The treated group had an absolute 16-19% lower risk for hospital-acquired pneumonia, the primary endpoint (36% vs. 51-54% depending on which intention-to-treat analysis you prefer, p=0.007 to 0.01). (n=150). JAMA 2011;305:1201-1209.

Mar 102011

Fernandez-Cerrano et al randomized 56 people with CAP in Spain (only 3 needed mechanical ventilation) to receive methylprednisolone bolus-and-taper or placebo, in addition to ceftriaxone and levofloxacin. The steroid-treated group had less hypoxemia (lower PaO2/FiO2). (n=56). Critical Care 2011;15:R96. FREE FULL TEXT MORE ON THIS: In AJRCCM 2005, Confalonieri found less septic shock and need [… read more]

Mar 092011

Accurso et al report phase 3 results from industry-funded TIGER-1, testing t.i.d. inhaled denufusol (an ion channel regulator that alters sodium/chloride transport to improve mucociliary clearance) vs. placebo in early cystic fibrosis (FEV1>74% predicted). After 24 weeks, FEV1 was 45 mL better in the treated group, most of whom were younger than age 19. There [… read more]

Mar 022011

In a rare encouraging positive study in the chronically critically ill, 71% of vent-dependent patients (~6 weeks on MV) who did multiple sets of daily inspirations backwards through a PEEP valve weaned from mechanical ventilation (defined as >72 hrs off the vent), vs. 47% receiving a sham treatment. MIP also improved by 10 cmH2O in [… read more]

Feb 182011

McCormack et al randomized 89 women with lymphangioleiomyomatosis to receive 2 mg rapamycin or placebo daily for 12 months, followed by 12 months of drug-free observation. Women receiving sirolimus had stable lung function on spirometry, fewer symptoms, fewer “respiratory events,” and better quality of life during the treatment period. This was tempered by GI, dermatologic, [… read more]

Feb 172011

Daily inhaled corticosteroids (ICS) may retard growth in children, who would rather play than take daily inhalers. Martinez et al randomized children with mild persistent asthma to four groups, one of which was beclomethasone + albuterol as rescue therapy only (i.e., no daily ICS), for 44 months. They did slightly worse than children taking daily [… read more]

Feb 162011

Ciclesonide, a new inhaled corticosteroid that seems to cause thrush less often than others, reached for equivalency with salmeterol/fluticasone in mild persistent asthma. Ciclesonide was better than placebo in controlling asthma but Advair users had a longer time to first asthma exacerbation. CHEST 2011;139: online supplement. A Cochrane review on ciclesonide could not establish its [… read more]

Feb 152011

In a very small trial (n=24), inhaled RNA (ALN-RSV01) appeared to improve outcomes in lung transplant patients with RSV respiratory infections, by interfering with viral replication. Symptoms were reduced, and at 90 days, incidence of bronchiolitis obliterans syndrome was 6% vs 50% in the control group. AJRCCM 2011;183:531-538.

Feb 122011

Louie et al report results of a phase 3 industry-funded trial of fidaxomicin, a poorly absorbed oral macrolide that’s bacteriocidal vs C. difficile. The new drug was equivalent to oral vanco in curing C.diff infections (~90%), and superior at preventing recurrences (~14% vs 24%). It did not prevent recurrences of the more lethal and increasingly [… read more]