iPEGASUS
Trial question
What is the role of cardiac index-guided therapy in high-risk patients undergoing major open abdominal surgery?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
40.0% female
60.0% male
N = 318
318 patients (127 female, 191 male).
Inclusion criteria: high-risk patients undergoing elective major open abdominal surgery.
Key exclusion criteria: planned laparoscopic surgery; pregnancy; heart rhythms other than sinus rhythm; LVEF < 30%; aortic valve stenosis; pheochromocytoma; acute myocardial ischemia in the past 30 days; septic shock; anuric renal failure.
Interventions
N=152 cardiac index-guided therapy (maintaining optimized post-induction cardiac index with pulse pressure < 12% during and for the first 8 hours after surgery using intravenous fluids and dobutamine).
N=166 routine care (management of hemodynamics without cardiac index monitoring per local clinical routine).
Primary outcome
Rate of moderate or severe complications within 28 days after surgery
55.3%
46.4%
55.3 %
41.5 %
27.6 %
13.8 %
0.0 %
Cardiac index-guided
therapy
Routine
care
Significant
increase ▲
NNH = 11
Significant increase in the rate of moderate or severe complications within 28 days after surgery (55.3% vs. 46.4%; OR 1.87, 95% CI 1.03 to 3.39).
Secondary outcomes
No significant difference in the number of complications per subject within 28 days after surgery (1.3 events vs. 1.1 events; IRR 1.13, 95% CI 0.82 to 1.57).
No significant difference in days alive within 6 months after surgery (174.1 days vs. 167.2 days; MD 7.1, 95% CI -1.68 to 15.87).
No significant difference in the rate of death within 6 months after surgery (7% vs. 13%; OR 0.48, 95% CI 0.22 to 1.05).
Conclusion
In high-risk patients undergoing elective major open abdominal surgery, cardiac index-guided therapy was inferior to routine care with respect to the rate of moderate or severe complications within 28 days after surgery.
Reference
Sandra Funcke, Götz Schmidt, Alina Bergholz et al. Cardiac index-guided therapy to maintain optimised postinduction cardiac index in high-risk patients having major open abdominal surgery: the multicentre randomised iPEGASUS trial. Br J Anaesth. 2024 Aug;133(2):277-287.
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