Randomized Controlled Trials Archives - PulmCCM
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Randomized Controlled Trials Articles

Nov 232016
 
Breo Ellipta beat usual care for COPD in real-world study

GlaxoSmithKline recently got a boost for fluticasone-furoate + vilanterol (Breo Ellipta), its new once-daily COPD maintenance inhaler. Patients with COPD randomized to Breo Ellipta (called Relvar Ellipta in Europe), instead of usual care, had 8% fewer exacerbations and no increased risk for serious adverse events over one year. GSK presented the data at the ERS [… read more]

Nov 182016
 
Does intensive rehab and physical therapy in the ICU really help?

Every year, over a million people in the U.S. suffer respiratory failure requiring mechanical ventilation. They experience enormous catabolic stress, extended periods of inactivity, and usually go without their usual caloric intake. It’s no surprise that many are rendered profoundly debilitated by the experience. For many, this weakness and loss of muscle mass represents a second [… read more]

Nov 172016
 
Older transfused blood as good as fresh (INFORM)

What’s the shelf life of human blood? Like the milk in your fridge, stored donated human blood has an expiration date: currently it’s 42 days, set by the FDA. But is fresher blood actually better? As with ordering wine by the glass, should patients about to be transfused blood ask for “whatever was opened most recently”? There’s [… read more]

Nov 082016
 
CPAP did not reduce cardiovascular risk, especially when not worn

Nightly use of continuous positive airway pressure (CPAP) did not prevent cardiovascular events in high risk patients with obstructive sleep apnea, according to a large randomized trial. The SAVE study suggests that CPAP has no cardiovascular benefits for the millions of people using it less than 4 hours a night. However, those using CPAP for more [… read more]

Nov 052016
 
Levosimendan in Septic Shock: the LeoPARDS study

“I want to be your medicine, I want to feed the sparrow in your heart …” -Kristian Matsson Case A 39 year old woman is admitted to the intensive care unit for hypotension, anuria and altered mentation despite 3 litres of intravenous lactated ringers infusion.  She is febrile and found to have gram negative bacteremia [… read more]

Nov 022016
 
Long-term oxygen brought no benefits for moderate hypoxemia in COPD

In patients with COPD with exertional hypoxemia, long-term supplemental oxygen did not improve survival or quality of life in a multicenter randomized trial published in the New England Journal of Medicine. The NIH-funded study calls into question the current practice of routinely treating moderately hypoxemic COPD patients with supplemental oxygen, and the billions spent for it [… read more]

Oct 282016
 
Corticosteroids for sepsis didn't prevent septic shock (HYPRESS trial)

The idea that augmenting cortisol levels to normal or supranormal levels must be somehow beneficial in septic shock has a compelling basis in physiology and intuition. For physicians, injecting powerful synthetic hormones to restore homeostasis to save a dying patient is a seductive fulfillment of the scientist-savior fantasy. So intensivists were primed to believe the results of [… read more]

Jun 122016
 
Blood Pressure Goals in Intracerebral Hemorrhage - ATACH II

“… it is a tale.  Told by an idiot, full of sound and fury, signifying nothing.” Macbeth: Act V, Scene V The results of the ATACH II trial are out; we have even more guidance when managing the blood pressure of hypertensive patients with supratentorial, intra-cerebral hemorrhage of less than 60 cm3 in volume.  The question: [… read more]

Aug 272015
 
Limited cancer screening seems appropriate after unprovoked PE

Cancers can cause pulmonary embolism, and an unprovoked PE may signal an undiscovered cancer lurking in the body. In older studies, as many as 1 in 10 patients with unprovoked PE were diagnosed with cancer within a year. (The current terminology is that a PE is provoked if associated with a known cancer or another provoking factor, but [… read more]

Jul 172015
 
Recurrent PE risk after long-term warfarin therapy remains high (PADIS-PE)

Not long ago, doctors were taught that 6 months of anticoagulation was plenty for patients with unprovoked pulmonary embolism. That standard was never based on long-term outcomes studies. And as longer-range data started to come in — gulp — it was clear that large numbers of people treated with 6-month warfarin courses after unprovoked PE [… read more]

Jul 022015
 
Direct thrombin inhibitors associated with heart attack risk in multiple trials

Direct thrombin inhibitors (DTIs) are anticoagulants (blood thinners) most often used as alternatives to heparin and warfarin. DTIs are approved by the FDA for prevention and treatment of venous thromboembolism (deep venous thrombosis and pulmonary embolism) and to prevent blood clots in people with atrial fibrillation. But multiple randomized trials suggest these widely used anticoagulants might cause heart [… read more]

May 282015
 
Restricting calories by 50% during critical illness results in no harm

Everyone agrees that providing adequate nutrition in critical illness is vitally important. The problem is, no one knows for sure what “adequate” means. Caloric targets are not based on evidence from randomized trials with meaningful clinical outcomes. They emerge as consensus from educated guesses by researchers conducting physiology studies. One camp believes that extra calories should [… read more]

May 272015
 
High flow oxygen by nasal cannula saves lives over noninvasive ventilation

Image: F&P Healthcare Noninvasive ventilation (NIV), often referred to by the trade name “BiPAP®,” can prevent intubation and save lives in patients with COPD exacerbations or pulmonary edema due to heart failure. Its proven benefits and low risk have led to NIV being used for patients in respiratory failure in virtually every acute care setting [… read more]

May 172015
 
The only VAP prevention method that saves lives is the one you’re not using

There’s always been doubt about the efficacy of the numerous “ventilator bundles” hospitals use to prevent ventilator-associated pneumonia (VAP). A provocative new analysis concludes that none of these methods save lives — except the one that almost no ICUs are using today. Healthcare associated pneumonias (HAP), especially ventilator-associated pneumonias (VAP), are associated with increased mortality, excess antibiotic use, lengthened hospital [… read more]

Apr 122015
 
Antibiotics for community-acquired pneumonia: Is azithromycin out?

Is it time for a change in the standard treatment of community-acquired pneumonia? A new Dutch study says, maybe. The Infectious Diseases Society of America (IDSA) says, not so fast. IDSA’s guidelines for treatment of community acquired pneumonia were last updated in 2007. For patients admitted to the hospital but not needing the ICU, they have [… read more]

Mar 272015
 
Endovascular therapy helps in ischemic stroke, again (ESCAPE)

Endovascular Therapy Improves Outcomes from Ischemic Stroke By Parth Rali, MD and Igor Titoff, DO Endovascular therapy for ischemic stroke has long been an attractive treatment modality for ischemic strokes, but until recently large randomized trials have not confirmed a benefit [1,2,3]. Two of these—IMS III1 and SYNTHESIS2—failed to prove the benefit of endovascular therapy (with-or-without tissue plasminogen activator) [… read more]

Mar 202015
 
ProMISe Trial for Sepsis: Usual Care 3, Goal-Directed Therapy 0*

* (since 2014) The ARISE (Australasia) and ProCESS (U.S.) trials, published in 2014, each demonstrated no advantage of protocolized care for sepsis over conscientious usual care. For those remaining unconvinced, the U.K.-based ProMISe trial is available in the New England Journal of Medicine. ProMISe extends the growing global footprint of what some will call the [… read more]

Mar 062015
 
Chlorhexidine baths in ICU don't prevent infections in large trial

Throwing the Baby out with the (Chlorhexidine) Bathwater? New Data on Disinfectant Baths By Lekshmi Santhosh, MD As a critical care community, we’ve been forever searching for a magic bullet to eradicate healthcare-acquired infections. So when the pair of 2013 NEJM trials on daily chlorhexidine bathing showed statistically significant reductions on the incidence of hospital-acquired [… read more]

E-cigarettes double smokers’ quit rates vs placebo: meta-analysis

 Policy, Ethics, Education, Randomized Controlled Trials, Review Articles  Comments Off on E-cigarettes double smokers’ quit rates vs placebo: meta-analysis
Mar 052015
 
E-cigarettes double smokers' quit rates vs placebo: meta-analysis

Electronic cigarettes containing nicotine can double smokers’ rates of quitting at one year, compared to e-cigarettes without nicotine (placebo), according to a new small meta-analysis published in the Cochrane Database of Systematic Reviews. The rates of smoking cessation using nicotine-containing e-cigarettes (9%) were roughly comparable to that seen with other forms of nicotine replacement therapy in past trials. The [… read more]

Feb 192015
 
Chantix works even if you're just thinking of quitting smoking

“Set a quit date to stop smoking,” goes the old bit of doctor’s advice. Experts argue people need to psyche themselves up, get serious, commit to quitting before the last butt goes in the ashtray. A new study in JAMA suggests that advice may be outdated. Smokers unready to quit who took the cessation drug varenicline (Chantix) for several months, [… read more]