Randomized Controlled Trials Articles

May 142017
 
Heparin prophylaxis no help after knee arthroscopy or leg casting (POT-KAST, POT-CAST)

Low molecular weight heparin (LMWH) at preventive doses after arthroscopic knee surgery or leg casting did not prevent venous thromboembolism (DVT or PE), in two Dutch randomized trials. The study helps fill a large gap in knowledge regarding risks and benefits of prophylactic anticoagulation in patients undergoing these procedures. In one (POT-KAST), 1,543 patients received [… read more]

May 072017
 
Video laryngoscopy was no better than directly intubating in the ICU, and may have been worse (MACMAN)

Video laryngoscopy provides beautiful close-up views of the larynx, by navigating a sensor past the tongue and pharyngeal tissues that can obstruct direct laryngoscopy views. These visual advantages led to its wide adoption by anesthesiologists, emergency physicians, and intensivists after video laryngoscopy’s introduction in the late 1990s. The intuition that better visualization must result in improved intubation rates — [… read more]

Apr 122017
 
Which position is safest for central line placement: subclavian, jugular, femoral? (3SITES)

Where to place a central venous catheter is a decision driven mainly by individual experience and preference. The limited evidence available has not established any site as superior; the subclavian position has been reported as being less infection-prone, but more likely to cause pneumothorax, compared to other sites. A large French randomized trial adds significantly to the evidence base. [… read more]

Apr 052017
 
Meta-analysis confirms EGDT for sepsis is unhelpful and wasteful (PRISM)

Three large, well-conducted randomized trials around the world (ProCESS, ARISE, and ProMISe) all agreed: use of early goal-directed therapy (EGDT) for sepsis does not improve mortality or any other important clinical outcome. The Big Three sepsis trials were a death knell for the formerly ubiquitous “sepsis bundles,” protocols based on the single-center 2001 trial of EGDT [… read more]

Apr 052017
 
Pre-hospital hypothermia hurt, not helped after cardiac arrest

Therapeutic hypothermia after cardiac arrest was almost immediately accepted as standard care in 2002 when two smallish, unblinded randomized trials (n=77 and n=273) showed a significant benefit from hypothermia after out-of-hospital ventricular fibrillation cardiac arrest. Hospitals and their cardiac care units quickly adopted resource-intensive protocols to manage patients’ special needs while being cooled to an icy 33° [… read more]

Mar 232017
 
Fish oil in pregnancy prevented asthma in kids at age 5

Can fish oil supplements taken during pregnancy prevent asthma in children? According to a randomized trial in the New England Journal of Medicine, yes. Children of 736 pregnant women who took supplements containing given n-3 long-chain polyunsaturated fatty acid during their third trimester had a 31% relative reduction in risk of developing asthma or persistent [… read more]

Mar 152017
 
Should FDA mandate lower nicotine content in cigarettes?

In June 2009, then-President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act, authorizing FDA to regulate the nicotine content of cigarettes. The only real limit to FDA’s new authority was a provision prohibiting FDA from “requiring the reduction of nicotine yields of a tobacco product to zero.” Prior to that [… read more]

Mar 092017
 
LABA safety studies for asthma saw no increased risk in Advair or Symbicort

After the Serevent Nationwide Surveillance (SNS) and SMART trials both appeared to link the use of long-acting beta agonists (LABAs) to an increased risk of asthma-related death, routine asthma care got scary. The FDA slapped a black box warning on LABAs like Serevent (salmeterol) and Foradil (formoterol) and also the combination treatments containing them (Advair, [… read more]

Mar 022017
 
Therapeutic hypothermia? No benefit in cooling kids after in-hospital cardiac arrest (THAPCA)

Cooling kids to 33ºC after resuscitation from in-hospital cardiac arrest brought no benefits compared to fever prevention (maintenance at 36.8°C), in the large THAPCA randomized trial. After one year, survival was 39% with hypothermia and 36% with management of body temperature in the normal range. There were no differences in neurologic outcomes or any other [… read more]

Feb 152017
 
Oxygen saturation in critical illness: could low-normal be best?

Oxygen is essential for life, but by forming superoxides and free radicals, supplemental oxygen can also inflict damage on lung and other body tissues. The sweet spot for oxygen delivery in critically ill patients is unknown, but increasing evidence suggests that when it comes to blood oxygen saturation during critical illness, “normal” levels might actually [… read more]

Feb 092017
 
Reslizumab (CINQAIR) worked as add-on treatment for severe asthma with eosinophilia

Reslizumab (CINQAIR) is a humanized, anti-IL-5 biologic agent approved by FDA in March 2016 as add-on treatment for asthma with peripheral blood eosinophilia, uncontrolled by usual treatments. In two randomized trials, reslizumab improved lung function and asthma symptoms in patients meeting these criteria. Patients without high eosinophil count in peripheral blood did not experience clinically [… read more]

Feb 082017
 
Early renal replacement therapy in critical illness did not improve outcomes (AKIKI)

When is the optimal time to initiate renal-replacement therapy in the ICU? Patients with acute renal failure (a.k.a. acute kidney injury or AKI) in the ICU experience worse outcomes than patients who do not. As the kidneys shut down, toxic electrolytes and metabolic waste products build up in the blood. Intuition says — screams, really [… read more]

Jan 182017
 
Azithromycin was no help in asthma exacerbations (AZALEA)

Adding azithromycin to usual treatment for asthma exacerbations in adults did not improve asthma symptoms or speed their resolution, investigators reported in the AZALEA randomized clinical trial. Patients getting azithromycin also had no improvement in lung function. Azithromycin is known to have some activity against viruses that infect bronchial cells; viruses are causative or contributory [… read more]

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

By Jon-Emile S. Kenny [@heart_lung] “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 [… 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]