When compared to placebo, rifaximin reduced the risk of breakthrough episodes of hepatic encephalopathy over a six-month treatment period (22.1% vs 45.9%, HR 0.42; 95% confidence interval, 0.28-0.64, P<0.001), as well as risk of hospitalization involving hepatic encephalopathy (13.6% vs 22.6%, HR 0.50; 95% CI, 0.29-0.87, P=0.01).
The incidence of adverse effects was similar in both groups. More than 90% of patients received concomitant lactulose therapy.
Bottom line: Rifaximin treatment delays the first breakthrough episode of hepatic encephalopathy during a six-month period; moreover, it significantly reduces the associated risk for hospitalization.
Citation: Bass NM, Mullen KD, Sanyal A, et al. Rifaximin treatment in hepatic encephalopathy. N Engl J Med. 2010;362:1071-1081.
Early Tracheotomy Does Not Decrease the Incidence of Ventilator-Associated Pneumonia in ICU Patients
Clinical question: Does early tracheotomy decrease the incidence of ventilator-associated pneumonia (VAP) in mechanically ventilated adult ICU patients without existing lung infection?
Background: There is considerable variation in timing and incidence of tracheotomy across ICUs. Observational studies have reported that tracheotomy performed earlier might be associated with quicker weaning from mechanical ventilation; however, randomized, controlled trials have failed to confirm this finding.
Study design: Multicenter randomized controlled trial.
Setting: Adult ICU in Italy.
Synopsis: Between 2004 and 2008, 600 mechanically ventilated patients without lung infection were enrolled from 12 adult ICUs in Italy. Of these patients, 419 were randomized to early tracheotomy performed six to eight days after intubation (N=209) or to late tracheotomy performed 13-15 days after intubation (N=210).
VAP was diagnosed in 14% of patients in the early tracheotomy group, compared with 21% in the late tracheotomy group (P=0.07). Although the number of ventilator-free and ICU-free days was higher in the early tracheotomy group, long-term outcomes did not differ between the two groups.
Only 69% of patients in the early tracheotomy group and 57% of patients in the late tracheotomy group received tracheotomy, but all the patients were included in the final analysis due to the intention-to-treat design of the study, which might have diluted the effect of the intervention. In addition, the smaller sample size may have prevented the study from reaching statistical significance.
Bottom line: Early tracheotomy does not significantly decrease the incidence of VAP as compared to late tracheotomy.
Citation: Terragni PP, Antonelli M, Fumagalli R, et al. Early vs. late tracheotomy for prevention of pneumonia in mechanically ventilated adult ICU patients. JAMA. 2010;303(15): 1483-1489.
Coagulopathy in Cirrhotic Patients Is Not Protective against VTE
Clinical question: Does the degree of INR elevation affect the incidence of VTE in hospitalized patients with cirrhosis?
Background: Chronic liver disease (CLD) and subsequent development of cirrhosis renders patients coagulopathic. Historically, this has provided a sense of security to clinicians that these patients inherently possess a decreased VTE risk.
Study design: Retrospective cohort study.