Randomized Controlled Trials

May 242020
 
Does the 65 Trial Dial Down the Mean Arterial Pressure in Sepsis?

Jon-Emile S. Kenny MD [@heart_lung] “This whole thing is not about heroism.  It’s about decency.  It may seem a ridiculous idea, but the only way to fight the plague is with decency.” -Albert Camus Background In 2013, Dünser and colleagues communicated a rogue viewpoint in shock resuscitation – let us do away with strict macro-hemodynamic goals [… read more]

Feb 092020
 
Vitamin C didn't improve septic shock in VITAMINS trial

A new randomized trial showed no benefit from intravenous vitamin C in patients with sepsis, but delays in treatment baked into the trial design will keep hope alive for true believers in the novel therapy. Vitamin C, hydrocortisone, and thiamine have been promoted as a lifesaving adjunctive therapy for septic shock, based on anecdotal data [… read more]

Jan 202020
 
Adding Vitamin D no help in critical illness, even in deficient patients

Vitamin D supplementation brought no measurable benefits to vitamin D-deficient critically ill patients, in a large randomized trial published in the New England Journal of Medicine. Vitamin D supplementation has long been hoped for as a potential lifesaving therapy in critical illness. Many critically ill patients are vitamin D deficient, and deficiency increases the risk [… read more]

Dec 272019
 
The PHARLAP Trial: Recruitment Maneuvers Buy Stairway to Heaven?

Jon-Emile S. Kenny MD [@heart_lung] “Dying is a wild night and a new road.” -Emily Dickinson Background In 2006, a recruitment maneuver to achieve an ‘open lung’ was circulated; it has since been dubbed ‘stairway recruitment’ given its stepwise upthrusts in airway pressure [see figure 1]: Plodding up this ladder of airway pressure was meant to [… read more]

Dec 122019
 
Inhaled steroids may not work for half of asthma patients

Inhaled corticosteroids have been the mainstay of treatment for persistent asthma for decades. A new trial suggests that for the ~50% of asthma patients with low sputum eosinophils, inhaled steroids are no better than placebo, and neither was tiotropium. Treatment with the inhaled glucocorticoid mometasone or the long-acting muscarinic antagonist tiotropium resulted in similar outcomes [… read more]

Nov 172019
 
Beta-blockers doubled risk of hospitalization from COPD exacerbations (BLOCK-COPD)

Beta-blockers have generally been considered safe and beneficial for patients with COPD, but a new randomized trial calls that assumption into doubt. The use of oral beta blockers without a cardiac indication appeared to double the risk of hospitalization for people experiencing a COPD exacerbation. Authors randomized 532 patients with moderate or severe COPD with [… read more]

Nov 082019
 
Can C-reactive protein improve treatment for COPD exacerbations?

Use of C-reactive protein (CRP) in decision-making may reduce antibiotic use in COPD exacerbations, but not as a replacement for clinical judgment, a study suggested. Chronic obstructive pulmonary disease (COPD) exacerbations are characterized by increased inflammation in the airways and the body generally. C-reactive protein (CRP) is a serum test for inflammation, and has been [… read more]

Oct 312019
 
Vitamin C reduces mortality from sepsis with ARDS in CITRIS-ALI randomized trial ... ?

Vitamin C infusion has generated tremendous interest as an adjunctive treatment for patients with sepsis, since a widely publicized cohort study claimed vitamin C dramatically reduced sepsis-related mortality at a single institution. The publicity, the plausible pathophysiologic mechanism, and the lack of any therapy for sepsis have led many intensivists to prescribe the so-called Marik [… read more]

Oct 182019
 
Prolonged hypothermia improved neurologic outcomes after non-shockable cardiac arrests (HYPERION, CRICS-TRIGGERSEP)

Targeted temperature management (TTM, or therapeutic hypothermia) has become standard therapy after cardiac arrest, especially for ventricular tachycardia and fibrillation–so called shockable rhythms. A new randomized trial has shown that deep, prolonged cooling after cardiac arrest from non-shockable rhythms (PEA and asystole) improved neurologic outcomes. But how robust were the results, and should they change [… read more]

Sep 062019
 
Prophylactic IVC filters prevent PE in high-risk trauma patients, but were often unnecessary

Inferior vena cava filters placed prophylactically in patients hospitalized for trauma prevented symptomatic pulmonary embolism in those patients with persistent contraindications to anticoagulation, in a significant randomized trial. However, prophylactic IVC filter placement for all post-trauma patients did not improve outcomes generally. Trauma teams have always faced a difficult dilemma in the prevention and treatment [… read more]

May 302019
 
Neuromuscular blockade for ARDS was no help, in supine patients

Continuous neuromuscular blockade for severe ARDS became common practice after the ACURASYS trial (2010) showed it reduced mortality by an absolute 9%. A larger trial, ROSE, now finds no benefit of the therapy over usual care — but leaves lingering questions due to major design differences. The ROSE trial was a multicenter randomized trial in [… read more]

Apr 142019
 
Titrating PEEP using esophageal pressures did not improve ARDS outcomes (EPVent-2)

In acute respiratory distress syndrome (ARDS), using pleural pressure to adjust positive end-expiratory pressure (PEEP) has long been considered a cumbersome but theoretically ideal technique to optimize ventilator management. Using esophageal pressure as a surrogate for pleural pressure can allow one to calculate and minimize the transpulmonary pressure gradient, elevations in which are the putative [… read more]

Apr 072019
 
Bag-mask ventilation during intubation in ICU prevents severe hypoxemia

A randomized trial confirmed what most intensivists have long believed and practiced: in the moments before endotracheal intubation, we should help patients achieve the highest arterial oxygen saturation possible, using bag-mask ventilation (BMV). This seems self evident — why wouldn’t we? Bag-mask ventilation can distend the stomach with air, potentially increasing the risk for vomiting [… read more]

Apr 072019
 
Early norepinephrine improved septic shock, prevented pulmonary edema

Guidelines advise physicians give large boluses of intravenous crystalloid infusions (two to three liters, generally) to patients with septic shock. Vasopressors are typically begun only if patients’ blood pressure remains low after fluid administration. A vocal minority of researchers have advised against delaying vasopressors in septic shock, arguing that norepinephrine, not intravenous fluid, is the [… read more]

Apr 072019
 
Andexanet works as antidote to apixaban, rivaroxaban, data show

by Nicole Lou, Contributing Writer, MedPage Today HONOLULU — Andexanet alfa (Andexxa), the reversal agent for anticoagulants in the factor Xa inhibitor class, worked for patients who developed acute major bleeding while on one of these agents, the full report of the ANNEXA-4 study confirmed. A bolus of the antidote saw median anti-factor Xa activity drop more [… read more]

Mar 172019
 
Proton pump inhibitors did not improve outcomes in ICUs (SUP-ICU trial)

Proton pump inhibitors (PPIs) are widely prescribed to mechanically ventilated patients to prevent gastrointestinal (GI) bleeding. The evidence for their use is not strong; individual randomized trials have not shown a clear benefit over histamine blockers, but when many trials were pooled into meta-analyses, PPIs do appear to be superior. The Surviving Sepsis Guidelines have [… read more]

Mar 152019
 
Time to start using newer oral anticoagulants for DVT-PE in cancer patients?

About one in five patients with cancer will develop pulmonary embolism (PE) or deep venous thrombosis (DVT), together called venous thromboembolism (VTE). Cancer patients who develop VTE are four times more likely to have experience another (recurrent) DVT or PE. Twice-daily injections of enoxaparin are advised for patients with cancer-related DVT/PE, or who are at [… read more]

Mar 152019
 
New antibiotic Omadacycline is effective for community-acquired pneumonia

by Molly Walker, Staff Writer, MedPage Today Omadacycline, a novel antibiotic in the tetracycline class, was non-inferior to standard of care for both community-acquired bacterial pneumonia and acute bacterial skin and skin-structure infections, two randomized trials found. There was no significant difference in early clinical response among patients with community-acquired bacterial pneumonia randomized to omadacycline and those [… read more]

Mar 082019
 
How should we relate to "unreasonable" families in the ICU?

Most families have never suffered through a loved one experiencing prolonged critical illness and respiratory failure (defined as ventilator dependence for weeks, usually with a tracheostomy). But each year, more do. An estimated 400,000 people currently live with chronic critical illness in long-term acute care hospitals (LTACHs) and other facilities — a population that has [… read more]

Feb 232019
 
Should We Stop Trending Lactate in Septic Shock?  ANDROMEDA-SHOCK Published

Jon-Emile S. Kenny MD [@heart_lung] “The truth is balance, but the opposite of truth, which is unbalance, may not be a lie.” -Susan Sontag Case A 49 year old man presents with two days of hemoptysis, right-sided pleuritic chest pain and a few hours of ‘confusion’ according to his teammate in a pick-up hockey league.  One [… read more]