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.

Abstract

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.

• Authors: Neil Singla, David C Warltier, Sweeta D Gandhi, Philip D Lumb, Robert N Sladen, Solomon Aronson, Mark F Newman, Howard L Corwin, ESCAPE-2 Study Group
• Journal: Anesthesia and analgesia (Anesth Analg) Vol. 107 Issue 1 Pg. 59-67 (Jul 2008) ISSN: 1526-7598 [Electronic] United States
• PMID: 18635468 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Calcium Channel Blockers
• Pyridines
• clevidipine

Topics

• 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, therapeutic use)
• Treatment Failure