Randomized Controlled Trials

May 072011
 

De Smet et al reheat the data from their 2009 NEJM study, in which they cluster-randomized and crossed-over 5,939 patients staying >48hrs in 13 Dutch ICUs to receive either 1) standard care; 2) selective oropharyngeal decontamination (topical amphotericin B, colistin, and tobramycin in the oropharynx), or 3) selective digestive tract decontamination (the same drugs in the mouth, stomach, [… read more]

Apr 272011
 

Those patients with severe acute lung injury due to pneumonia or aspiration who received the rSP-C surfactant product did no better on important outcomes (28-day survival, need for ventilation, organ-failure-free days) than those receiving usual care, report Spragg et al.(n=843). AJRCCM 2011;183:1055-1061.

Apr 262011
 

Four-drug therapy (RIPE) requires high patient commitment and imposes logistical demands on health systems in developing countries. Lienhardt et al report that a fixed-drug combination (FDC) of rifampin, isoniazid, pyrazinamide, and ethambutol was noninferior in producing negative cultures at 18 months compared to taking the drugs separately (both arms ~94% cure rate) in Africa, Asia and Latin [… read more]

Apr 252011
 

Fen-phen died in court, but phenteramine was cleared of all serious charges. Gadde et al report phase III results for Qnexa (by Vivus), a phenteramine-topiramate combination. Over 56 weeks, takers of a double-dose of study drug lost 10 kg; single-dose, 8 kg; and placebo, 1.4 kg. There were plenty of side effects (dry mouth and paresthesias [… read more]

Apr 242011
 

Maki et al randomized 407 patients at 25 dialysis units to have their catheters “locked” for up to 6 months with either heparin, or “C-MB-P solution” (citric acid, methylene blue, and propylparaben). The patients getting the antimicrobial potion had a 0.29 relative risk for bloodstream infection (BSI) without loss of catheter patency. (n=407) Crit Care Med 2011;39:613-620.

Apr 182011
 

After implementing an “MRSA bundle” in 2007 including nasal surveillance, contact precautions for positive patients, hand hygiene, and culture-indoctrination of employees, MRSA infections among all VA hospital ICUs fell from 1.64 to 0.62 per 1000 patient-days (a 62% reduction, p<0.001). MRSA infections on the wards fell from 0.47 to 0.26 per 1000 patient-days (45% reduction, [… read more]

Apr 182011
 

Huskins et al cluster-randomized 18 ICUs to an intervention of surveillance cultures with contact precautions for positive patients, or a control of no cultures and universal precautions (gloves). The intervention ICUs used contact precautions more frequently (51% vs. 38%), but had the same MRSA/VRE colonization/infection rates, the primary endpoint (40 vs 35%, p=0.35). Clinician compliance [… read more]

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]