The edition · Emergency & Critical Care
Class I recall of American Regent adrenaline vials, and capillary refill-guided resuscitation edged towards lower septic shock mortality
The FDA has classed a recall of 30 mL multiple-dose adrenaline vials for particulate matter as Class I. A meta-analysis of seven trials puts peripheral perfusion-guided resuscitation close to a mortality benefit, and a pilot trial found cooling heatstroke patients to 35°C caused harm without benefit.
The edition in brief
The FDA lists a Class I recall, ongoing, of American Regent's adrenaline (epinephrine) injection 1 mg/mL in 30 mL multiple-dose vials for particulate matter (nylon, cellulose, acrylic, polyethylene and glass), broken and leaking vials, and lack of sterility assurance. A meta-analysis of seven randomised trials (2,408 adults with septic shock) found peripheral perfusion-guided resuscitation, typically using capillary refill time, gave a 28-day mortality risk ratio of 0.87 (0.76 to 1.01) with no heterogeneity; a Bayesian analysis put the probability of any benefit at 97%. Across 15 studies and 2.6 million paediatric encounters, the Phoenix sepsis criteria predicted in-hospital death with an AUC of 0.81, better than the older consensus criteria (0.71), but specificity varied widely by setting. A pilot trial in 35 intubated heatstroke patients found cooling to 35°C for 48 hours caused more severe gastrointestinal injury (53% vs 0%) and arrhythmia (41% vs 11%) than controlled normothermia, with no survival or functional benefit. In US claims, 43% of new psychoactive prescriptions in the month after ventilated ICU stays had no documented supporting diagnosis. The perfusion meta-analysis is the strongest evidence today but did not reach statistical significance.
Class I recall: American Regent adrenaline 30 mL multiple-dose vials
Check for and remove recalled American Regent 30 mL adrenaline vials, and inspect any vial for particles before drawing up an infusion.
The Phoenix sepsis criteria predicted paediatric mortality better than the older definition
Use the Phoenix criteria to stratify mortality risk in children with suspected infection, not to screen for early sepsis.
Cooling intubated heatstroke patients to 35°C caused more harm than controlled normothermia
After initial rapid cooling, maintain normothermia rather than prolonged hypothermia in intubated heatstroke patients.
Four in ten new psychoactive prescriptions after a ventilated ICU stay had no recorded reason
Reconcile psychoactive drugs started in intensive care before discharge, with a documented indication and stop date for any that continue.
Adrenaline for anaphylaxis goes into the thigh muscle, not under the skin
Treat anaphylaxis with intramuscular adrenaline into the anterolateral thigh, repeated at five minutes if needed.
Capillary refill-guided resuscitation came close to lowering septic shock mortality
Consider capillary refill time as a resuscitation target in septic shock, alongside lactate, while a definitive trial is awaited.
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