Randomized Controlled Trials

Mar 102013
 
Hope floats: Fecal transplants cure >90% of recurrent C. difficile (RCT)

Fecal Transplants Cure C. difficile Infections, When Drugs Can’t Antibiotics are what cause Clostridium difficile infection to emerge in the first place, so it’s perhaps no surprise that the usual treatment — more antibiotics — often fails. From 15-25% of patients with C. difficile are not permanently cured by their initial treatment with metronidazole, and among those [… read more]

Mar 062013
 
Diuretics beat ultrafiltration at treating congestive heart failure with acute renal failure (RCT)

Ultrafiltration No Better Than Diuresis for CHF Exacerbations by Blair Westerly, MD Cardiorenal syndrome — simultaneous heart failure and renal failure — is a frequently encountered problem in people with acute decompensated heart failure.  Treatment with diuretics for congestive heart failure exacerbations is standard care, but diuretics may at times worsen renal function. Venovenous ultrafiltration [… read more]

Mar 032013
 
"Trach collar" beats pressure support trials for long-term ventilator weaning (RCT)

“Trach Collar” Trials Beat Pressure Support for Long-Term Ventilator Weaning By Blair Westerly, MD Patients requiring prolonged mechanical ventilation linger in ICUs and long-term acute care hospitals for weeks, accounting for a significant portion of intensive care unit costs and often suffering serious complications while dependent on the ventilator. Despite this issue’s rising importance, the [… read more]

Feb 192013
 
Time to retire routine replacement of peripheral IVs

Time to Retire Routine Replacement of Peripheral IVs Study question:  Do peripheral I.V.s need to be changed every 72-96 hours per the CDCs recommendations or can they be changed as clinically indicated? How many times as a resident did you receive a call at 4 a.m., often at the very moment you were about to [… read more]

Feb 072013
 
Blood transfusion harmful in some patients with GI bleeds (RCT)

Blood Transfusion: Deadly for GI Bleeds? You read the headline right: in a randomized trial published in the New England Journal of Medicine, liberal blood transfusions (to a hemoglobin of 9 g/dL) seemed to harm people with acute upper gastrointestinal bleeding, as compared to transfusing when hemoglobin fell below 7 g/dL. People with mild to moderate [… read more]

Jan 312013
 
Etomidate associated with increased mortality in sepsis: meta-analysis

Etomidate: Unsafe for Intubation in Patients with Sepsis? by Blair Westerly, MD Etomidate is commonly used for rapid sequence intubation; however, even after one dose, it has been associated with adrenal axis suppression in critically ill patients. Though both adrenal insufficiency and increased mortality in sepsis have been associated with etomidate, the relationship of the [… read more]

Jan 062013
 
Sedation vacations don't improve outcomes in large trial (RCT)

Do “Sedation Vacations” Really Speed Weaning From Mechanical Ventilation? Daily interruptions of sedation (“sedation holiday” or “sedation vacation”) became the standard of critical care for weaning from mechanical ventilation in ICUs around the world after J.P. Kress et al’s landmark 2000 New England Journal of Medicine paper showing daily sedation interruptions freed ~64 patients from ventilators [… read more]

Jan 062013
 
Intensive glucose control probably kills, says NICE-SUGAR post-hoc

Intensive glucose control in critically ill patients — keeping glucose below 120 with a continuous insulin drip — was all the rage for a few years in the early 2000s after it was shown to improve survival in surgery patients, and then seemed to do the same in non-surgical, critically ill MICU patients who were [… read more]

Jan 062013
 
PANTHER-IPF negative, stopped early for harm from steroids, Imuran in IPF (RCT)

(image: Wikipedia) As we reported a few months ago, the PANTHER-IPF trial was stopped early for safety, when it became clear that the combination of prednisone and azathioprine was hurting people with idiopathic pulmonary fibrosis (IPF). Ganesh Raghu (U-Washington), Kevin Anstrom (Duke), Talmadge King (UCSF) et al report the final results in the May 24 New [… read more]

Jan 062013
 
Precedex as good as Versed or Propofol, but with cardiovascular effects (RCT)

Precedex Takes Step Toward FDA Indication for Longer-Term Use Precedex (dexmedetomidine) only has existing FDA indications for short-term sedation (< 24 hours) in both mechanically ventilated and non-intubated patients. That short leash is because of dexmedetomidine’s tendency to produce  hypotension and bradycardia, and has limited Precedex’s approved uses mainly to elective surgeries and other invasive procedures. Many intensivists use Precedex off-label for critically [… read more]

Jan 042013
 
Azithromycin reduces exacerbations in non-CF bronchiectasis (RCT)

Azithromycin for non-CF Bronchiectasis Bronchiectasis — the permanently dilated, tortuous bronchi that can result after previous lung infections — is a frustrating problem for pulmonologists to treat, but not nearly as frustrating as it can be for patients to live with. People with bronchiectasis are plagued by chronic coughing, and many experience a steady decline [… read more]

Jan 032013
 
Inhaled corticosteroids stunt growth of America's youth by a half-inch

Daily Inhaled Steroids Stunt Kids’ Growth, Study Shows If you’re a half-inch shy of six feet, the next time you’re getting your jump shot blocked by your non-asthmatic friend, you can blame the inhaled corticosteroids your Mom made you take as a kid. Studies have consistently showed children’s height slows down for a few years [… read more]

Jan 032013
 
At treating asthma, patients may be as good as their doctors (BASALT trial)

Consensus guidelines advise that patients with regular symptoms of asthma should take inhaled corticosteroids every day, and when they’re having poor asthma control, they should tell their doctor, who can increase the steroid dose or add other “step-up” therapies. But asthma symptoms vary daily and can worsen at any time. And it can be hard [… read more]

Jan 022013
 
Adding tiotropium (Spiriva) helped some with uncontrolled asthma (RCT)

Spiriva (Tiotropium) for Uncontrolled Asthma Most people with asthma can achieve good control with inhaled corticosteroids (ICS) and a long-acting beta-agonist (LABA). Some people living with asthma, though, experience persistent symptoms despite maximum doses of these inhaled medications. Fairly or not, LABAs have also been sullied with an FDA black-box warning for worsening bronchospasm in a [… read more]

Jan 012013
 
Hydroxyethyl starch fries kidneys in another large trial (RCT)

Hydroxyethyl Starch (Voluven) Causes Kidney Failure In Large Trial Hydroxyethyl starch (HES) was already wearing a scarlet letter as an potentially dangerous volume resuscitation agent for patients in shock, after evidence emerged this year that hydroxyethyl starch kills people with severe sepsis. Now, another huge, convincing trial shows that hydroxyethyl starch (Voluven) damages kidneys and [… read more]

Dec 292012
 
Xigris' epitaph: "I Never Worked a Day in My Life" (PROWESS-SHOCK)

Recombinant human activated protein C or dotrecogin alfa — better known as Xigris, by Eli Lilly — seemed a godsend when it was first approved for treatment of severe sepsis in 2001. Xigris’ FDA approval (despite an evenly split 10-10 vote) was based solely on the Eli Lilly-funded PROWESS study, a phase 3 randomized trial [… read more]

Dec 292012
 
Oral rivaroxaban (Xarelto) noninferior to warfarin for PE (RCT)

(image: InPharm) Rivaroxaban (Xarelto) was noninferior to standard treatment (heparin and warfarin) in preventing recurrent VTE in patients with acute pulmonary embolism (PE), in the large EINSTEIN-PE randomized trial published in the April 5 New England Journal of Medicine. A once-daily oral factor Xa inhibitor that has already been demonstrated to be noninferior for treatment [… read more]

Dec 292012
 
An aspirin a day keeps recurrent DVT and PE away (RCT)

(image: Rex Parker) Among people with unprovoked deep venous thrombosis (DVT) or pulmonary embolism (PE), 1 in 5 will experience another DVT or PE within 2 years after stopping anticoagulation with warfarin (Coumadin). For this reason, the ACCP’s recommendations for treatment of unprovoked proximal DVT or PE suggest consideration of an “indefinite” period of anticoagulation [… read more]

Dec 262012
 
Pleural catheters equal to pleurodesis for dyspnea relief from malignant effusions (TIME2)

(image: Wikipedia) In the TIME2 randomized trial published in the June 13 2012 JAMA, indwelling pleural catheters and talc pleurodesis were equivalent at reducing dyspnea over the 6 weeks following the procedure among 106 patients with malignant pleural effusions. Most patients receiving pleural catheters required no hospital stays, and overall had fewer repeat procedures than those [… read more]

Dec 242012
 
Hydroxyethyl starches kill people with severe sepsis; use crystalloid instead (RCT)

Colloids are believed to be more effective expanders of plasma volume than crystalloids, making them a tempting therapy to use for patients in septic shock and other causes of hemodynamic instability. Problem is, some colloid solutions seem to kill people. The VISEP Trial using hydroxyethyl starch 200 kDa/0.5 demonstrated that this high molecular weight HES [… read more]