Results of permissive hypotension trial are not prescriptive

  • Lamontagne F & al.
  • JAMA
  • 12 Feb 2020

  • curated by Jenny Blair, MD
  • Clinical Essentials
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Takeaway

  • This trial of permissive hypotension in elderly ICU patients with vasodilatory hypotension did not find that the strategy lowered mortality.
  • However, confidence intervals and adjusted analyses meant minimizing exposure to vasopressors “was unlikely to be harmful and might have been beneficial.”
  • Editorial : “the signal suggests that this deliberate intervention [of giving pressors] may be harmful…clinicians could be reassured in the finding that assiduously targeting an arbitrary blood pressure is not helpful.”

Why this matters

  • Vasopressor risks and benefits are difficult to balance, especially in the elderly.
  • SEPSISPAM and OVATION tentatively linked pressors to mortality in this subgroup.

Key results

  • Permissive hypotension vs usual care: 
    • Median total dose (norepinephrine equivalent), 17.7 vs 26.4 mg (difference, −8.7 [95% CI, −12.8 to −4.6] mg).
    • Mortality: 41.0% vs 43.8%;
      • Absolute risk difference, −2.85% (95% CI, −6.75% to 1.05%).

Study design

  • Pragmatic, open, multicenter, parallel group, randomized clinical trial in 65 UK ICUs (n=2463).
  • Adults age ≥65 years with vasodilatory hypotension receiving vasopressors were randomly assigned to a permissive-hypotension MAP target (60-65 mmHg) vs clinician discretion.
  • Outcome: 90-day all-cause mortality.
  • Prespecified superiority criterion: 6% absolute risk reduction.
  • Funding: National Institute for Health Research (UK).

Limitations

  • Nonblinded.
  • Not a noninferiority trial.