What is the fatality rate of propofol (2,6-diisopropylphenol) infusion syndrome?

From the Guidelines

The fatality rate of propofol infusion syndrome (PRIS) is approximately up to 33%, making it a rare but potentially life-threatening complication of propofol administration. This syndrome typically occurs when propofol is administered at high doses (> 70 μg/kg/min) for prolonged periods, though cases have been reported at lower doses and shorter durations 1. PRIS is characterized by worsening metabolic acidosis, hypertriglyceridemia, hypotension with increasing vasopressor requirements, and arrhythmias, as well as acute kidney injury, hyperkalemia, rhabdomyolysis, and liver dysfunction 1. Some key points to consider when managing patients on propofol infusions include:

• Monitoring for early signs of PRIS, such as unexplained metabolic acidosis, cardiac arrhythmias, or elevated creatine kinase levels, particularly in critically ill patients requiring sedation for extended periods
• Early recognition and immediate discontinuation of propofol are essential for management, along with supportive care including hemodialysis, cardiovascular support, and correction of metabolic abnormalities
• The incidence of PRIS with propofol infusions is approximately 1% 1, highlighting the need for careful patient selection and monitoring. Given the high mortality rate associated with PRIS, healthcare providers should exercise caution when administering propofol, particularly at high doses or for prolonged periods, and be vigilant for signs of this potentially life-threatening complication.

From the FDA Drug Label

The results of the study showed an increase in the number of deaths in patients treated with propofol as compared to SSAs Of the 25 patients who died during the trial or within the 28-day follow-up period: 12 (11% were) in the propofol 2% treatment group, 9 (8% were) in the propofol 1% treatment group, and 4% were (4%) in the SSA treatment group.

The fatality rate of propofol infusion syndrome is not directly stated in the provided drug labels. However, the labels do report an increase in the number of deaths in patients treated with propofol compared to standard sedative agents (SSAs) in a clinical trial involving pediatric ICU patients.

• The fatality rates in this trial were:
  • 11% in the propofol 2% treatment group
  • 8% in the propofol 1% treatment group
  • 4% in the SSA treatment group 2 It is essential to note that propofol infusion syndrome is a rare but potentially life-threatening condition associated with the use of propofol. The provided information does not directly address the fatality rate of propofol infusion syndrome. Key points:
• The provided drug labels do not directly state the fatality rate of propofol infusion syndrome.
• The labels report an increase in the number of deaths in patients treated with propofol compared to SSAs in a clinical trial involving pediatric ICU patients 2

From the Research

Fatality Rate of Propofol Infusion Syndrome

The fatality rate of propofol infusion syndrome (PRIS) is a critical aspect of understanding the risks associated with the use of propofol, especially in critically ill patients. According to the available evidence:

• A study published in the Journal of Critical Care in 2022 3 reported a PRIS-associated mortality rate of 36.8%.
• An earlier study in Intensive Care Medicine from 2003 4 described PRIS as a rare and often fatal syndrome, indicating a high fatality rate, although a specific percentage was not provided.
• A review in Drug Safety from 2008 5 characterized PRIS as a rare but frequently fatal complication, suggesting a significant fatality rate without specifying a exact percentage.
• A structured review of experimental studies and 153 published case reports in Critical Care from 2015 6 found that factors such as propofol infusion rate and duration, traumatic brain injury, and fever are independently associated with mortality in PRIS cases, but did not provide a single fatality rate.
• A retrospective analysis at a level 1 trauma center published in Critical Care Research and Practice in 2014 7 reported a case-fatality rate of 33% among patients who developed PRIS.

Key Factors Influencing Fatality Rate

Several factors can influence the fatality rate of PRIS, including:

• Duration and dose of propofol infusion: Higher doses and longer durations of infusion are associated with a higher risk of developing PRIS and its fatal outcomes 3, 4, 5, 6, 7.
• Presence of underlying conditions: Patients with traumatic brain injury, acute neurological illnesses, or inflammatory diseases may have a higher risk of fatal outcomes from PRIS 4, 6.
• Early recognition and intervention: Prompt recognition of PRIS symptoms and immediate cessation of propofol infusion, along with appropriate supportive care, can potentially reduce the fatality rate 3, 5.