[display_podcast]
Date: October 22nd, 2014
Reference: Goal-Directed Resuscitation for Patients with Early Septic Shock. The ARISE Trial. NEJM Oct 2014
Guest Skeptic: Dr. Suneel Upadhye. Associate Clinical Professor of Emergency Medicine, McMaster University. Associate Member Department of Clinical Epidemiology and Biostatistics. Chair Canadian Association of Emergency Physicians Standards Committee. Sepsis Researcher.
Case: 62-year-old man sent from a nursing home with a three day history of a productive cough, intermittent fevers and today is a bit confused. The transfer notes include a history of congestive heart failure, COPD, gout, hypertension, type-2 diabetes, and mild dementia. His vital signs are as follows: Temp 39.1C, heart rate 103, blood pressure 115/100, respiratory rate 26, Oxygen saturation Sat 92% and a normal blood sugar.
Questions: Does an ED patient with septic shock need aggressive EGDT or “usual” resuscitation?
Background: Suneel’s Five Key Points of Sepsis Care
* Recognize sepsis early
* Broad spectrum antibiotics
* Fluid resuscitation
* Lactate levels
* Transfer to appropriate care
Reference: Goal-Directed Resuscitation for Patients with Early Septic Shock. The ARISE Trial. NEJM Oct 2014
* Population: Adults >18yo presenting to emergency department within 6hrs with suspected/confirmed infection, 2+ SIRS criteria, and evidence of refractory hypotension (sBP<90 or MAP<65 after IVF >1000ml within 1st hour) or hypoperfusion (lactate >4).
* Exclusions: Age <18-years-old, contraindications to central venous catheter/blood products, imminent/inevitable death, underlying disease with <90 day life expectancy, inpt transfer from another facility, confirmed/suspected pregnancy, unable to randomize or start EGDT within 6-hours of ED arrival.
* Intervention: Full EGDT provided by a trained study team using a standardized EGDT delivery protocol
* Control: “Usual” care as per physician discretion. Use of SCVO2 NOT allowed. All patients mandated for IV antibiotics prior to randomization.
* Outcome:
* Primary Outcome: All-cause mortality at 90 days.
* Secondary/Tertiary Outcomes: 90 day survival time, ICU mortality, 28d mortality, in-hospital 60d mortality, cause-specific 90d mortality, length of stay in ED/ICU/hospital, use of critical interventions (mech ventilation, vasopressor support, renal dialysis), discharge destination of survivors, adverse events. A priori subgroup analyses for demographics, APACHE scores, mech ventilation, refractory hypotension, lactate level, and IV fluid resuscitation volume (<20cc/kg vs >20cc/kg).
Authors’ Conclusions: “In critically ill patients presenting to the emergency department with early septic shock, EGDT did no reduce all-cause mortality at 90 days.”
Quality Check List for Randomized Control Trials:
* The study population included or focused on those in the Emergency Department. Yes All patients were recruited from the ED Yes. All patients were recruited from the emergency department.
* The patients were adequately randomized. Yes
* The randomization process was concealed. Yes
* The patients were analyzed in the groups to which they were randomized. Yes
* The study patients were recruited consecutively (i.e. no selection bias). Yes
* The patients in both groups were similar with respect to prognostic factors. Yes
* All participants (patients, clinicians, outcome assessors) were unaware of group allocation. No