KT Evidence Bites: ProCESS Trial

In Knowledge Translation by Eve Purdy1 Comment

Editor’s note: This is a new series based on work done by three physicians (Patrick Archambault, Tim Chaplin, and our BoringEM Managing editor Teresa Chan)  for the Canadian National Review Course (NRC). You can read a description of this course here.

The NRC brings EM residents from across the Canada together in their final year for a crash course on everything emergency medicine. Since we are a specialty with heavy allegiance to the tenets of Evidence-Based Medicine, we thought we would serially release the biggest, baddest papers in EM to help the PGY5s in their studying via a spaced-repetition technique. And, since we’re giving this to them, we figured we might as well share those appraisals with the #FOAMed community! We have kept much of the material as drop downs so that you can quiz yourself on the studies.

Paper: A Randomized Trial of Protocol-Based Care for Early Septic Shock

Citation: N Engl J Med. 2014 May 1; 370(18):1683-93. Epub 2014 Mar 18. PMID: 24635773

Nickname of study: ProCESS trial

Summarized by: Patrick Archambault
Reviewed by: Teresa Chan & Tim Chaplin

Rationale for Study

1) Is protocol-based resuscitation better to usual care?

2) Is a protocol with central hemodynamic monitoring to guide the use of fluids, vasopressors, blood transfusions, and dobutamine (“Early Goal Directed Therapy”) better than a simpler protocol that does not include these elements?

Clinical Question

In patients with septic shock presenting to the ED, is a …

  1. catheter-based goal-directed resuscitation protocol better than
  2. usual care or a
  3. simplified goal-directed resuscitation protocol?
PopulationIn patients with septic shock presenting to the ED, is a catheter-based goal-directed resuscitation protocol better than usual care or a simplified goal-directed resuscitation protocol?
InterventionCatheter-based goal-directed sepsis protocol
Controla) Simplified goal-directed sepsis protocol

b) Practice as usual (no prompts by study coordinator and bedside physicians were not trained to deliver EGDT or protocol-based standard therapy)
Outcome1) hospital mortality rate at 60 days
2) mortality rate at 90 days
3) cumulative mortality at 90 days and 1 year
4) secondary outcomes (length of cardiovascular, respiratory, renal failure, length of hospital and ICU stay, discharge disposition)

Methods

RCT: outcome assessment was blinded but not healthcare professionals, intention to treat analysis

Results

1) Fluid administered in the first 6 hours was significantly different between groups (P<.001):

  • EGDT: 2.8L
  • protocol-based standard care: 3.3L
  • usual-care: 2.3L

2) Dobutamine use was significantly different between groups  (P<0.001):

  • EGDT: 8.0%
  • protocol-based: 1.1%
  • usual care 0.9%

3) Packed Red Blood Cells was significantly different between groups (P = 0.001):

  • EGDT: 14.4%
  • protocol-based: 8.3%
  • usual care: 7.5%

4) Primary outcome: 60 day mortality (P=.55 for three way comparison)

  • EGDT: 21.0%
  • protocol-based 18.2%
  • usual care: 18.9%

5) No differences in other primary endpoints.

6)  Secondary outcomes: Need for Renal replacement Therapy was higher in protocol-based standard care (P=0.04)

  • protocol-based: 6.0%
  • EGDT: 3.1%
  • usual-care: 2.8%

Conclusion

1) There is no significant advantage, with respect to mortality or morbidity, of protocol-based resuscitation over bedside care that was provided according to the treating physician’s judgment

2)  There is no significant benefit of the mandated use of central venous catheterization and central hemodynamic monitoring in all patients

Take Home Point

The ProCESS trial identifies early recognition of sepsis, early administration of antibiotics, early adequate volume resuscitation, and clinical assessment of the adequacy of circulation as the elements we should focus on to save lives.

EBM Considerations

1) 10 years after the original EGDT Rivers study, the usual-care group has changed and has potentially integrated principles of the EGDT protocol, early recognition of sepsis, early antibiotics, lower tidal volumes, tighter blood sugar control.

2) We don’t know if randomization was concealed.

3) The EGDT group seemed sicker at baseline (more abdominal sepsis, lower BP, longer time to randomize) .

4) External applicability: these were all academic centers, a full research team prompting clinicians to act and follow time sensitive protocols (a study coordinator, bedside nurse and a dedicated research physician).

To download a copy of this summary click here.

 

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Eve Purdy

Eve Purdy

Senior Editor at BoringEM
Senior emergency medicine resident and anthropology student-happily consuming, sharing, creating and researching #FOAMed.
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