Randomized Controlled Trials Archives - PulmCCM
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Randomized Controlled Trials Articles

Apr 182014
 
Thrombolytics (tPA) improve intermediate risk PE outcomes, with a few head bleeds (PEITHO Trial)

The use of thrombolytics for pulmonary embolism is not controversial — that is, if the PE is massive with hypotension (give thrombolytics) or mild, with normal blood pressure and right ventricular function (don’t give them). It’s the patients with intermediate risk pulmonary emboli — with normal blood pressure but with evidence of right ventricular dysfunction [... read more]

Apr 182014
 
Steroids did not improve outcomes in severe COPD exacerbations (RCT)

Image: 1800petmeds Systemic steroids in COPD exacerbations requiring ventilator support: Are we treating our patients, or ourselves? By Muhammad Adrish, MD Acute exacerbations of COPD are a major cause of hospitalizations, and are associated with more rapid decline in lung function and reduced survival. Because COPD exacerbations are associated with increased inflammatory responses, corticosteroids have [... read more]

Apr 132014
 
Albumin for severe sepsis and septic shock: More confusing findings (ALBIOS Trial)

Source: KP Albumin: Better Than Crystalloid in Septic Shock? Human albumin boosts oncotic pressure, and has a number of important biologic functions (protein binding, antioxidant, etc.) that could in theory support the body during critical illness. In the 2004 SAFE study, which tested albumin against crystalloid solutions in ~7,000 critically ill patients of various etiologies, 4% [... read more]

Apr 112014
 
PulmCCM Roundup #3

PulmCCM Roundup #3 All the best in pulmonary and critical care we’ve found lately. Browse all the PulmCCM Roundups. Surviving Sepsis Campaign Responds to ProCESS Trial In the wake of the ProCESS trial demonstrating no benefit from use of protocols for septic shock, the Surviving Sepsis Campaign released a statement in which they “continue to recommend [... read more]

Apr 042014
 
Catheter directed thrombolysis for submassive PE: better than heparin? (RCT)

Image: EKOS Patients with acute pulmonary embolism (PE) fall into three general clinical categories: Massive PE, most often defined as hypotension due to right ventricular dysfunction. Short-term mortality is high (more than 1 in 7 die in-hospital). Systemic thrombolytic therapy (tissue plasminogen activator or tPA) is considered standard care by AHA and ACCP, because it [... read more]

Mar 292014
 
No benefit from higher mean arterial pressure in most with septic shock

In Septic Shock, Goal of MAP > 65 mm Hg Remains Standard by Abhishek Biswas, MD In the 13 years since Rivers et al published their seminal paper that established “early goal directed therapy” for sepsis as the standard of care, treatment for severe sepsis and septic shock have evolved dramatically. Newer research questions the wisdom [... read more]

Mar 212014
 
Early goal directed therapy does not improve outcomes in septic shock (ProCESS)

Can we finally “Just Say No” to the mandatory use of central venous catheters and central venous saturation in severe sepsis and septic shock? by Muhammad Adrish, MD In a single center study published in 2001, Rivers et al reported that patients with severe sepsis and septic shock had significantly lower mortality (30.5% vs 46.5%) [... read more]

Feb 152014
 
Tight glycemic control in critically ill kids: benefits, risks still unclear

Intensive insulin therapy for critically ill adults was rapidly adopted as standard care after 2001 when an apparent benefit was established after cardiac surgery, then medical ICU patients. Eleven years later, after a wave of minor harm signals, the NICE-SUGAR study confirmed for most intensivists that the excess hypoglycemia from intensive glucose control was potentially lethal in adults, and [... read more]

Feb 012014
 
Spiriva and heart attack risk: new safety kerfuffle

Last year, PulmCCM reported on the TIOSPIR safety trial comparing the Spiriva dry-powder HandiHaler against the Respimat mist-delivery device. TIOSPIR showed no difference in all-cause mortality or composite cardiovascular risk endpoints between either Spiriva preparation. But this week, a group of drug safety researchers report their granular analysis of TIOSPIR data shows the Respimat device [... read more]

Jan 262014
 
Antibiotics don't improve cough in acute bronchitis

Acute bronchitis with cough is overwhelmingly often due to viral infection, but that doesn’t stop coughers from seeking antibiotics, or their doctors from obligingly prescribing them. Most patients who ask for antibiotics get them, and the millions of excess antibiotic doses worldwide each year are believed to contribute to rising antibiotic resistance. Doctors seem almost [... read more]

Jan 192014
 
Macitentan for IPF falls short in MUSIC trial

Blair Westerly, MD Effective treatment for idiopathic pulmonary fibrosis continues to elude patients and clinicians alike.  Multiple classes of medications have been studied, none with convincing data demonstrating efficacy.  Because of the proposed  contribution of endothelin-1 to the pathogenesis of IPF, receptor antagonists of this growth factor have previously been evaluated in IPF, but with [... read more]

Jan 182014
 
Implantable tongue-buzzer improves obstructive sleep apnea by 70%

Source: Inspire Med Systems Hypoglossal Nerve Stimulation Markedly Improves OSA An estimated 15% of men and 6% of women in the U.S. have clinically significant obstructive sleep apnea, meaning it worsens their daytime cognitive functioning, cardiovascular risk, or both. In obstructive sleep apnea, muscle tone in the soft tissues of the pharynx (throat) is insufficient [... read more]

Jan 122014
 
Hypothermia might harm, not help, in bacterial meningitis

Hypothermia No Help for Bacterial Meningitis by Blair Westerly, MD Therapeutic hypothermia got “hot” after trials in the early 2000′s showed improvement in neurological outcomes in global cerebral hypoxia after cardiac arrest. (Any benefit of targeted temperature management below 36° Celsius is in serious doubt after a much larger randomized trial contradicted those earlier, smaller trials, showing no [... read more]

Dec 012013
 
Do colloids save lives in hypovolemic shock?

So, your patient’s in shock: quick, give some fluids. But colloids or crystalloids? How to choose? They both raise blood pressure, they both improve organ perfusion — but one’s less filling, the other tastes great (what, you haven’t tried them?). It’s no wonder the question makes your head hurt; the evidence base is a jumble. The [... read more]

Nov 282013
 
CPAP for sleep apnea improved drug-resistant hypertension

Most people with obstructive sleep apnea (OSA) have high blood pressure (hypertension), but treating OSA with continuous positive airway pressure (CPAP) has been shown to reduce blood pressure only minimally (by about 2.5 mm Hg). A randomized trial in the November 2013 Chest suggests that in people with severe drug-resistant hypertension with OSA, CPAP can [... read more]

Nov 232013
 
Hypothermia did not help after out-of-hospital cardiac arrest, in largest study yet

No Improvement in Cardiac Arrest Outcomes With Hypothermia Therapeutic hypothermia, or targeted temperature management, has become a standard component of post-cardiac arrest care. The evidence supporting this practice came from two small-to-medium-sized randomized trials, both published in the New England Journal of Medicine in 2002: Among 273 patients with out-of-hospital cardiac arrest due to shockable [... read more]

Nov 082013
 
Statins don't help in ventilator-associated pneumonia treatment

Statins have anti-inflammatory and immune-modulating effects, and among critically ill patients, continuing or starting statins have improved soft outcomes in observational and small randomized studies. For example, starting a statin reduced progression of sepsis in ward patients and statins improved organ failure scores in acute lung injury (the HARP trial). But in their first shot at [... read more]

Nov 082013
 
"CPAP cures metabolic syndrome" paper in NEJM: retracted!

In early 2012, PulmCCM breathlessly reported the results of a New England Journal of Medicine (NEJM) paper by Surenda K. Sharma et al, claiming to show that continuous positive airway pressure (CPAP) can reverse metabolic syndrome (obesity, dyslipidemia, and insulin resistance). Whoops. The authors retracted the article after keen-eyed academics smelled something fishy and asked [... read more]

Nov 062013
 
Olodaterol, a new once-daily LABA, proven effective for COPD

Olodaterol Olodaterol, a new once-daily inhaled long-acting beta agonist, improved lung function and exercise capacity in chronic obstructive pulmonary disease (COPD) in two randomized trials (n=199) presented by Gregory Feldman et al at the Chest 2013 meeting in Chicago. The new once-daily LABA olodaterol will reportedly be marketed by Boehringer Ingelheim under the trade name Striverdi [... read more]

Oct 312013
 
Breo Ellipta (vilanterol/fluticasone) matches Advair in RCT

Breo Ellipta (GlaxoSmithKline) is the first FDA-approved combination product with a once-daily long acting beta agonist (vilanterol) and inhaled corticosteroid (fluticasone). Additional once daily combination ICS/LABA and LABA/antimuscarinics are expected to launch over the next decade, increasing the options for treatment of asthma and COPD. GSK got good news in the October Chest, with the publication [... read more]