Goal-Directed Resuscitation for Patients with Early Septic Shock
The ARISE Investigators and the ANZICS Clinical Trials Group
The recent PROCESS trial possibly indicated that no one approach to resuscitation was better than another and therefore the use of a central line in a patient was not always required.
Prospective, randomized, parallel group trial in 51 tertiary care and non tertiary care metropolitan and rural hospitals mainly in Australia and New Zealand.
Usual Care- Decisions about the location of care delivery, investigations, monitoring and all treatments were made by the treating clinical team. ScvO2 measurement were not permitted in the 6 hour intervention period.
EGDT- An arterial catheter and ScvO2 catheter were inserted one hour after randomisation. Resuscitation algorithm was based on the original EGDT algorithm. These patients had a dedicated study team trained in EGDT delivery. Care providers and location of delivery dependent on local resources.
Patients 18 years or older. Confirmed or suspected infection and two or more criteria for SIRS with evidence of refractory hypotension (systolic blood pressure of less than 90 or a MAP of less than 65 after a fluid challenge of 1 litre within a 60 minute period) or hypoperfusion (blood lactate level of 4mmol/l or more).
Commencement of first dose IV antimicrobial therapy prior to randomisation.
Contraindication to CVC insertion in the SVC and contraindication to blood products. Heamodynamic instability due to active bleeding, aggressive care deemed unsuitable by clinician, inability to deliver EGDT within 1 hour of randomisation or inability to deliver EGDT for 6 hours.
Primary outcome was death from any cause within 90 days.
Secondary outcomes included 28 day mortality, in hospital mortality at 60 days, length of stay in ED and ITU, receipt and duration of mechanical ventilation , vasopressor support, renal replacement therapy and destination at discharge.
792 patients in the EGDT group and 796 in the usual care group.
Total fluid administrated for both groups was approx. 2.5 litres (35mls/kg) with an average lactate of 6.6-6.7 mmol/l
Similar groups in age, gender, APACHE II, invasive ventilation, non invasive ventilation and use of vasopressors.
Use of fluids, RBC and dobutamine significantly reduced in the usual care arm in the first 6 hours.
The differences in the use of vasopressors and dobutamine persisted up to 72 hours but there was no difference in the use of fluids between the two arms over this period.
High degree of compliance with all resuscitative endpoints and goal directed therapies.
No difference in the endpoint goals in either arm.
No difference between EGDT and usual care in 90 day all cause mortality
EGDT 18.6% vs usual care 18.8%
EGDT had a shorter length of stay in ED and more were admitted to ICU direct from ED (however in a number of participating sites patients needed to be admitted to the ICU for the EGDT to be delivered).
More EGDT patients received a vasopressor infusion.