Do Physiologic Doses of Hydrocortisone Benefit Patients With Septic Shock?
Background: Meta-analyses and guidelines advocate the use of physiologic dose steroids in patients exhibiting septic shock. However, recommendations are largely based on the results of a single trial where benefits were seen only in patients without a response to corticotropin.
Study design: Multicenter, randomized, double-blind, placebo-controlled study.
Setting: Fifty-two participating ICUs in nine countries.
Synopsis: A total of 499 patients with evidence of infection or a systemic inflammatory response characterized by refractory hypotension were randomly selected to receive either an 11-day tapering dose of hydrocortisone or a placebo. The primary outcome was death from any cause at 28 days. A corticotropin stimulation test was conducted on every patient to assess adrenal function. There were no differences in death rates or duration of hospitalization between study arms. Overall, there were 86 deaths in the hydrocortisone group and 78 deaths in the placebo group (p=0.51). Also, response to corticotropin appeared to have little bearing on outcomes.
The study was underpowered due to low enrollment and a lower-than-expected death rate. Nevertheless, this is the largest trial to date examining the role of steroids in the management of septic shock and calls into question the strength of prior data and published guidelines.
Bottom line: This study failed to demonstrate a clinically or statistically significant treatment effect from the administration of physiologic-dose steroids in patients with septic shock.
Citation: Sprung C, Annane D, Keh D, et al. Hydrocortisone therapy for patients with septic shock. N Engl J Med. 2008;358(2):111-124.
Does Open or Endovascular Repair of Abdominal Aortic Aneurysm Benefit the Medicare Population?
Background: Randomized controlled trials (RCT) have shown a perioperative survival benefit of endovascular repair over open repair with fewer complications and shorter recovery. There is concern that late morbidity may be increased with endovascular repair. Patients enrolled in the trials were highly selected at specialty centers, so the results may not reflect actual practice.
Study design: Retrospective, propensity-matched, observational cohort study.
Synopsis: 22,830 patients were matched in each cohort. Patients were eligible if they had an abdominal aortic aneurysm repair without rupture and excluded if they were enrolled in health maintenance organizations.
Outcomes included death within 30 days and late survival, perioperative complications, aneurysm rupture, reintervention, and laparotomy-related complications. The average age was 76, and 20% were women. Perioperative mortality was lower after endovascular repair (1.2% vs. 4.8%, p<0.001), and older patients had a greater benefit. Late survival was similar. By four years, rupture was more likely in the endovascular group (1.8% vs. 0.5%, p<0.001), as was reintervention (9% vs. 1.7%, p<0.001).
In contrast, by four years, surgery for laparotomy-related complications was more likely in the open-repair group (9.7% v 4.1%, p<0.001), as was hospitalization for bowel obstruction or abdominal-wall hernia (14.2% v 8.1%, p<0.001). Limitations included the non-randomized design and use of administrative data for important categorical variables including medical co-morbidities.
Bottom line: As compared with open repair, endovascular repair of abdominal aortic aneurysm is associated with lower short-term death and complications and higher late reinterventions. This is balanced by an increase in laparotomy-related reinterventions after open repair.
Citation: Schermerhorn ML, O’Malley AJ, Jhaveri A, Cotterill P, Pomposelli F, Landon BE. Endovascular vs. open repair of abdominal aortic aneurysms in the Medicare population. N Engl J Med. 2008 Jan 31;358(5):464-474.
What Therapy Improves Outcomes in ICU Patients With Severe Sepsis or Septic Shock?
Background: Evidence suggests lower mortality with intensive insulin therapy in post-surgical cardiac patients. There is no proven benefit for non-surgical ICU patients. Despite lack of data, intensive insulin in severe sepsis has been widely advocated. Little is known to guide the use of colloid or crystalloid for fluid resuscitation in sepsis.