Treatment of acute postoperative hypertension in cardiac surgery patients: an efficacy study of clevidipine assessing its postoperative antihypertensive effect in cardiac surgery-2 (ESCAPE-2), a randomized, double-blind, placebo-controlled trial

Anesth Analg. 2008 Jul;107(1):59-67. doi: 10.1213/ane.0b013e3181732e53.


Background: Acute postoperative hypertension is a well-known complication of cardiac surgery and is associated with postoperative morbidity. Clevidipine, an ultrashort-acting, third-generation dihydropyridine calcium channel blocker, exerts vascular-selective, arterial-specific vasodilation to decrease arterial blood pressure without negatively impacting cardiac function. In this double-blind, placebo-controlled trial, we examined the efficacy and safety of clevidipine in treating postoperative hypertension in cardiac surgery patients.

Methods: Two hundred six patients undergoing cardiac surgery were randomized preoperatively. Of these, 110 met postrandomization inclusion criteria for the study [systolic blood pressure (SBP) >or=140 mm Hg within 4 h of admission to a postoperative setting, and clinically assessed as needing SBP reduction by >or=15% from baseline]. Patients received an infusion of either clevidipine (0.4-8.0 microg kg(-1) min(-1)) or 20% lipid emulsion (placebo) for 30 min to a maximum of 1 h unless treatment failure occurred sooner. The primary end point was the incidence of treatment failure, defined as the inability to decrease SBP by >or=15% from baseline, or the discontinuation of study treatment for any reason within the 30-min period after study drug initiation.

Results: Clevidipine-treated patients had a significantly lower incidence of treatment failure than placebo patients [8.2% (5 of 61) vs 79.6% (39 of 49), P < 0.0001]. Treatment success was achieved in 91.8% of clevidipine-treated patients. Median time to target SBP with clevidipine was 5.3 min (95% confidence interval, 4-7 min). No clinically significant increase in heart rate from baseline was observed. Adverse event rates were similar for both treatment groups.

Conclusions: Clevidipine is effective and safe in the rapid treatment of acute postoperative hypertension after cardiac surgery.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Disease
  • Adult
  • Aged
  • Calcium Channel Blockers / therapeutic use*
  • Cardiac Surgical Procedures / adverse effects*
  • Double-Blind Method
  • Female
  • Humans
  • Hypertension / drug therapy*
  • Male
  • Middle Aged
  • Postoperative Complications / drug therapy*
  • Prospective Studies
  • Pyridines / adverse effects
  • Pyridines / therapeutic use*
  • Treatment Failure


  • Calcium Channel Blockers
  • Pyridines
  • clevidipine