Randomized Controlled Trials Archives - PulmCCM
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Randomized Controlled Trials Articles

Sep 122014
 

All the best in the pulmonary and critical care medicine literature from our ongoing journal survey. Browse all the PulmCCM Roundups to stay up to date. Thrombolytics for Pulmonary Embolism: New Metaanalysis Most patients with massive pulmonary embolism (PE with shock) should receive thrombolytics, but it’s unclear from randomized trial data which patients with submassive pulmonary embolism [... read more]

Jul 202014
 
PulmCCM Roundup #5

The PulmCCM Roundup gathers all the best in pulmonary and critical care from around the web.  Browse all the PulmCCM Roundups. Statins Fail for COPD, ARDS Statins have been optimistically tested as a tonic for everything from diabetes to dementia — so far, without success. That consistency was maintained in 2 recent trials showing statins’ [... read more]

Jul 112014
 
Prone positioning reduces ARDS mortality by 26%: meta-analysis

Image: Rotoprone Acute respiratory distress syndrome (ARDS) injures the lungs in a heterogeneous pattern, and the damaged areas are particularly vulnerable to further ventilator-induced lung injury. This is why a lung-protective ventilator strategy using low tidal volumes reduces mortality from ARDS, experts believe. Tidal volumes of 6 mL/kg ideal body weight (calculated from height) using conventional [... read more]

Jun 262014
 
CPAP better than oxygen for obstructive sleep apnea

About half of people diagnosed with obstructive sleep apnea (OSA) can’t or won’t use the most effective therapy, overnight continuous positive airway pressure (CPAP). Most people with untreated OSA experience multiple episodes of hypoxemia — sometimes hundreds per night. For many patients declining CPAP treatment, their doctors provide overnight oxygen, in the hope that it might [... read more]

Jun 082014
 
PulmCCM Roundup #4

All the best in pulmonary and critical care from around the web. Browse all the PulmCCM Roundups. Asthma Childhood obesity increases the risk for asthma, and obesity is also strongly associated with asthma in adults. The mechanisms are likely multiple, complex and interdependent (pro-inflammatory mediators, etc.), not simply causative. Losing weight does seem to improve [... read more]

Jun 052014
 
Tenecteplase for submassive PE: more conflicting evidence (TOPCOAT)

By Parth Rali, MD and Marvin Balaan, MD Submassive pulmonary emboli (PE) are those that are severe enough to produce right ventricular dysfunction on echocardiogram or elevated biomarkers (mainly troponin), but not hemodynamic instability (i.e., systemic blood pressure and cardiac output are preserved). The management of the patient with submassive PE is a matter of controversy with several [... read more]

May 302014
 
N-acetylcysteine: no benefit in idiopathic pulmonary fibrosis

NAC for IPF: Fail (PANTHER-IPF Wrap-Up) Long ago, when pulmonologists were more ingenuous (in 2000), flawed clinical trials convinced the American Thoracic Society to recommend prednisone and either azathioprine or cyclophosphamide in its consensus guideline for some patients with idiopathic pulmonary fibrosis (IPF). By not including a true control arm, the also-flawed follow-up 2005 IFIGENIA trial reinforced this [... read more]

May 272014
 
Nintedanib protects lung function, prevents exacerbations of idiopathic pulmonary fibrosis (INPULSIS)

In 2011 PulmCCM reported the findings of the phase 2 TOMORROW study, showing Boehringer Ingelheim’s tyrosine kinase inhibitor code-named BIBF 1120 reduced lung function decline and prevented exacerbations in people with idiopathic pulmonary fibrosis (IPF). At the 2014 American Thoracic Society annual meeting and in the New England Journal of Medicine, investigators announced their latest [... read more]

May 232014
 
Pirfenidone prolongs survival, preserves lung function in idiopathic pulmonary fibrosis (ASCEND)

For idiopathic pulmonary fibrosis treatment pirfenidone, the third time wasn’t the charm; the fourth was. After reducing decline in forced vital capacity over one year in a Japanese trial of 275 IPF patients, pirfenidone went one-and-one in the multinational CAPACITY trials (n=779), meeting the primary outcome of FVC preservation in one but not the other. [... read more]

May 072014
 
FDA approves implantable tongue-buzzer for obstructive sleep apnea treatment

Image: Inspire Med Systems Hypoglossal Nerve Stimulation for Sleep Apnea Wins FDA Approval The U.S. Food and Drug Administration approved Inspire Medical Systems’ pacemaker-like hypoglossal nerve stimulator for patients with moderate to severe obstructive sleep apnea (OSA) who cannot tolerate continuous positive airway pressure (CPAP). The Inspire device stimulates key airway muscles controlled by the hypoglossal [... read more]

May 032014
 
N-acetylcysteine for COPD: another trial shows benefit (PANTHEON)

Image: pipingrock.com Can N-acetylcysteine help prevent exacerbations of chronic obstructive pulmonary disease (COPD)? Another randomized trial says yes. N-acetylcysteine, or NAC, is a nutritional supplement with antioxidant and anti-inflammatory properties. After ingestion, N-acetylcysteine is metabolized into glutathione, a key antioxidant with effects throughout the body. In the lungs, glutathione deficiency (common in alcoholics) is linked [... read more]

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]