Effect of an early resuscitation protocol on in-hospital mortality among adults with sepsis and hypotension: a randomized clinical trial.
This single-centre, randomised, controlled, non-blinded study evaluated the potential beneficial effect of an early goal-directed therapy (EGDT) protocol on sepsis outcomes among 212 patients in Zambia.
The sepsis protocol was a modified version of the EGDT protocol proposed by Rivers et al. (N Engl J Med 2001;345:1368-77), with an initial bolus of 2 L of crystalloids (compared with more than 20 mL/kg in the Rivers protocol) and limitation of total fluid administration to 4 L in the six first hours after randomisation. A rescue vasopressor (dopamine) was administered if mean arterial pressure remained below 65 mmHg, and red blood cell transfusion was recommended in patients with a haemoglobin < 7 g/dL or severe pallor. In this particular population (young patients, more than 85% with HIV, 21% with tuberculosis pneumonia and septicemia), modified EGDT increased in-hospital mortality (48.1 %) compared with usual care (33%; P = 0.03). The EGDT protocol was actually an under-resuscitation protocol since patients received a median volume of 2.0 L and only 2% received a dopamine infusion. Despite the absence of treatment, mortality rate was surprisingly low!
The results of this study are in agreement with those reported by Maitland et al. (N Engl J Med 2011;364:2483-95) in African children, indicating that this study population was particularly susceptible to pulmonary oedema or reperfusion injury from the rate or amount of volume expansion, especially in the absence of sophisticated haemodynamic monitoring or possibility to intervene in case of complications.
– Michael Piagnerelli