A Randomized Trial of Protocol-Based Care for Early Septic Shock
N Engl J Med 2014; 370:1683-1693May 1, 2014DOI: 10.1056/NEJMoa1401602
At present I do not have access to the full document so can only provide an abbreviated summary of this article. However I can provide links to some of the discussion and concerns raised by this particular piece of research. When I get access to the full document I will break it down further to help in understanding the paper.
The Rivers trial in 2001 set the scene for the early goal directed therapy that we use today in the treatment of severe sepsis. The ProCESS trial aimed to see if the protocol driven approach was generalisable.
A multi centre randomised trial – 31 centres.
- Protocol based early goal-directed therapy emulating the Rivers protocol, with mandatory placement of a central line to continuously monitor ScVO2 and CVP, administration of IVF, vasopressors, dobutamine and PRBC
- Protocol based standard therapy, defined as 6-hour protocol prompted resuscitation with administration of IVF till “clinical” euvolemia and PRBC transfusion to goal hemoglobin of 7.5 g/dl or more; CVC placement and ScVO2 measurements were not mandatory
- Usual care: bedside provider directed all care without any prompted protocol
- Apache severity scores were equivalent across all three groups
- Amounts of fluid in first 6 hours – usual care group; 2.3, standard therapy; 2.8, protocol based; 3.3
- Patients in EGDT group received more dobutamine and PRBC in first 6 hours.
No differences in 60 day, 90 day or 1 year mortality between the groups.
So does this mean that EGDT is no better than standard care?
Is the study generalisable as it was carried out in large centres in the US?
The mechanism of identifying the septic patient meant that some interventions were already in lace when the patient had been enrolled into the study.
It would seem that there is no advantage to doing anything more than the ABCs of care.
Vasopressors- No differerence between groups on Rivers. ProCESS showed lower vasopressor use in usual care arm
Dobutamine- 14 fold difference in Rivers, 8 fold difference in ProCESS
PRBC- 3 fold difference in Rivers, 2 fold in ProCESS
In ProCESS trail EGDT had 93% rate of inserion of central lines versus 53% standardised care- ?lots of unnecessary insertion of central lines?
18% mortality far better than in Rivers trial – probably due to overall improvement in sepsis care over the years.
Continue to support MAP of 65 mm Hg in 6 hour bundle.
Do not necessarily support lactate testing
Recognise that there are other ways to get venous saturations other than the use of a central line?
Does not refute value of bundled care but places less emphasis on universal invasive monitoring.
Shoot first with antibiotics before getting sensitivities
Standard of usual care was very good – Hawthorn effect maybe?
A lot of practitioners use clinical findings rather than measured values to decide treatment, certainly in smaller centres.
Amount of fluids given was consistent with Rivers trial
Twice as many got central line in EGDT compared to other arms. However in protocol arm and standard therapy central line only used for fluid therapy and not for SCVO2 measurement.
Well executed study.
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