Randomized Controlled Trials

May 012018
 
Catheter-Directed Lysis Adds Risk, Not Benefit, for Proximal DVT

by Crystal Phend, Senior Associate Editor, MedPage Today Thrombolytics delivered to acute proximal deep-vein thrombus (DVT) with clot removal did not reduce the risk of post-thrombotic syndrome but did raise major bleeding risk over anticoagulant treatment alone in the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) clinical trial. The proportion of patients with post-thrombotic [… read more]

Apr 192018
 
Checking procalcitonin in the ICU saves lives? Maybe

Procalcitonin (PCT) levels can be useful (although limited) in deciding whether and when to start, de-escalate, and stop antibiotic therapy in patients with suspected infection. Physicians’ use of procalcitonin in antibiotic decisions has exploded since the FDA approval of a PCT assay whose manufacturer provides specific (albeit oversimplified) cut-off values at which to consider infection [… read more]

Apr 042018
 
Are balanced crystalloids better than saline? SMART Talk with Dr. Michael Pinsky

Jon-Emile S. Kenny MD [@heart_lung] with illustrations by Carla M Canepa MD “Each time new experiments are observed to agree with the predictions, the theory survives and our confidence in it is increased; but if ever new observation is found to disagree, we have to abandon or modify the theory.” — Stephen Hawking A 47 [… read more]

Mar 022018
 
Corticosteroids do help in sepsis: ADRENAL trial

Stress-dose corticosteroids appear safe and generally beneficial in patients with septic shock undergoing mechanical ventilation, without improving survival. That’s the takeaway from the ADRENAL trial recently published in the New England Journal of Medicine. Investigators (led by the famed ANZICS collaborative) randomized 3,800 patients with septic shock requiring mechanical ventilation in 69 medical-surgical ICUs around the [… read more]

Feb 162018
 
Ruling Out PE in the ED: Critical Analysis of the PROPER Trial

By Scott Aberegg, M.D., M.P.H. This post is going to be an in-depth “journal club” style analysis of the PROPER trial. In this week’s JAMA, Freund et al report the results of the PROPER randomized controlled trial of the PERC (pulmonary embolism rule -out criteria) rule for safely excluding pulmonary embolism (PE) in the emergency department (ED) [… read more]

Feb 152018
 
PERC Can Safely Rule Out Pulmonary Embolism in ED Setting

By Salynn Boyles, Contributing Writer, MedPage Today A clinical assessment protocol proved to be as effective as blood testing and CT imaging in the emergency department setting for ruling out pulmonary embolism in very low-risk patients in a newly reported French clinical trial. The crossover cluster-randomized PROPER study was conducted at 14 emergency departments (EDs) in France [… read more]

Jan 312018
 
Choose Wisely – Avoid Sildenafil for Pulmonary Hypertension in Corrected Left-Heart Valvular Disease (SIOVAC Trial)

Jon-Emile S. Kenny MD [@heart_lung] “It’s these expressions, I never give, That keep me searching for a heart of gold … And I’m gettin’ old.” -Neil Young An 86 year old woman is admitted with progressive dyspnea and lower extremity edema.  8 months ago she received a trans-catheter aortic valve replacement (TAVR) for severe aortic [… read more]

Jan 262018
 
FDA Approves First Nebulized LAMA for COPD

by Salynn Boyles, MedPage Today The FDA approved a nebulized formulation of glycopyrrolate (Lonhala Magnair) for long-term maintenance treatment of patients with moderate-to-severe COPD, said manufacturer Sunovion Pharmaceuticals. It’s the first long-acting muscarinic antagonist (LAMA) to be sold in this form. Recommended dosing is 25 mcg twice daily. The approval was made on the strength of data [… read more]

Jan 172018
 
Vitamin D improved asthma symptoms and reduced exacerbations

Multiple randomized trials have suggested that vitamin D supplementation might improve asthma control and reduce severity of asthma attacks. A new meta-analysis bolsters that hypothesis, and may encourage more physicians and people with asthma to consider vitamin D supplements for low vitamin D levels. In a study in Lancet Respiratory Medicine, authors analyzed the experience [… read more]

Jan 152018
 
N-acetylcysteine (NAC), sodium bicarbonate no help in preventing contrast nephropathy

N-acetylcysteine (NAC) and sodium bicarbonate are commonly provided to patients undergoing angiographic procedures with intravenous contrast. Small randomized trials had suggested NAC or bicarbonate or both could prevent kidney injury from so-called contrast nephropathy. That practice has no benefit, based on results of a large randomized trial showing neither NAC nor bicarb improved outcomes after [… read more]

Dec 182017
 
Esmolol in Sepsis: Microcirculatory Savior or Autoregulation Annihilator?

Jon-Emile S. Kenny MD [@heart_lung] Background If venous pressure were always the downstream pressure of an artery, then when flow is zero, the arterial pressure should equal the venous pressure.  For example, if one were to measure the coronary artery pressure and coronary sinus pressure at zero flow, their pressures should be equal.  Yet, this [… read more]

Dec 142017
 
Sedation interruptions were even more helpful in surgical patients

Most good medical intensive care units have incorporated interruptions in sedation (so-called ‘sedation vacations’) into standard care for patients receiving mechanical ventilation. Avoiding excessive sedation in general is believed to reduce prolonged mechanical ventilation in ICUs. However, there is surprisingly little data about effects of sedation (or over-sedation) on critically ill postoperative patients in the [… read more]

Dec 012017
 
Should patients watch videos of CPR before code status decisions?

Physicians and patients alike tend to avoid frank discussions about “code status” — whether a patient would want CPR or mechanical ventilation in the event of a cardiac or respiratory arrest. When doctors address code status at all, they tend to phrase the questions in such a way to cut off any thoughtful discussion: “If [… read more]

Nov 192017
 
Oral steroids don't improve cough due to colds (but are prescribed anyway)

Oral corticosteroids are frequently prescribed for persistent cough after the common cold in patients without respiratory disease. Like much of what physicians offer or advise, steroids for ordinary cough are traditionally provided not based on evidence, but on the premise that “it might help.” A new study in JAMA substantially undermines that premise. Authors randomized [… read more]

Nov 092017
 
FDA approves new phrenic nerve stimulator for central sleep apnea

The US Food and Drug Administration (FDA) approved an implanted phrenic nerve-stimulator device as a new treatment for moderate-to-severe central sleep apnea (CSA). The remedē System (Respicardia) consists of a pacemaker-like battery pack that’s surgically implanted in the upper chest beneath the skin. Wires electrically stimulate the phrenic nerve as it travels from the neck [… read more]

Nov 032017
 
Mepolizumab reduced exacerbations in COPD with eosinophilia, but missed target

The injectible monoclonal antibody mepolizumab (Nucala, GSK) is FDA-approved for severe asthma with blood eosinophilia, uncontrolled with standard controller inhaler treatments. Two randomized placebo-controlled trials keep alive for GSK the possibility of an FDA indication to reduce exacerbations in people with chronic obstructive pulmonary disease (COPD) with high blood eosinophil counts, expanding the drug’s market. The ~1,500 [… read more]

Oct 282017
 
Home BiPAP reduced readmissions after COPD exacerbations

Acute exacerbations of chronic obstructive pulmonary disease (COPD) are one of the top causes of hospital admission — and readmission: up to 30% of patients “bounce back” to the hospital within 90 days after a COPD exacerbation. Patients with severe COPD exacerbations with acute hypercapneic respiratory failure often receive noninvasive ventilation (NIV), commonly known as [… read more]

Oct 252017
 
Empiric micafungin didn't save lives in ICU-acquired sepsis

The antifungal micafungin is often given empirically to patients in ICUs with sepsis who are also at high risk for invasive fungal infections. IDSA guidelines endorse the use of empiric antifungals for patients with unresolving ICU-acquired sepsis, but any benefits of this are unknown. A randomized trial published in JAMA sheds light on the practice. French [… read more]

Oct 122017
 
Age of transfused red cells had no effect on mortality (TRANSFUSE)

U.S. medical centers vary widely in the average shelf life of the blood in their blood banks. Trauma and high-volume surgical centers receive the oldest blood from the Red Cross, on the premise that they’ll be likely to transfuse it. All blood banks tend to dispense the oldest units first. This reduces waste of donated [… read more]

Oct 082017
 
In sepsis, aggressive fluid resuscitation was harmful in randomized trial

In the U.S., the federal government strongly encourages physicians to give most patients with sepsis aggressive crystalloid fluid boluses (~2-3 liters), without regard to a patient’s individual condition.  In a randomized trial in JAMA, a similar standardized approach to aggressive fluid resuscitation in Africa appeared to cause the deaths of a significant proportion of patients [… read more]