Individualized Cardiac Index-Guided Hemodynamic Therapy in High-Risk Patients Undergoing Elective Major Abdominal Surgery: The PELICAN Randomized Clinical Trial.

Authors

Bernd Saugel, Agnes S Meidert, Christian S Meyhoff, Rune Sort, Eske K Aasvang, Alina Bergholz, Abdelkader Serir, Eike Schwartze, Kristen K Thomsen, Christian Zöllner, Stephan Berthold, Melanie Borrmann, Joseph Esser, Anja Laska, Patrick Scheiermann, Nicolai Bang Foss, Jonathan Winther Olsen, Line Malmer Madsen, Anders H Welling, Christine Gaik, Sebastian Roth, Julian Schröder, Marc Vives, Adam Klimovic, Michael Eichlseder, Sebastian Goldmann, Thomas Renné, Henrike Hedrich, Eik Vettorazzi, Antonia Zapf, Karim Kouz, Moritz Flick, PELICAN Trial Group

Published in

JAMA. Oct 19, 2026. Epub Oct 19, 2026.

Abstract

It remains unclear if intraoperative hemodynamic therapy should be guided by cardiac index.
To evaluate whether individualized cardiac index-guided hemodynamic therapy vs routine hemodynamic therapy improves outcomes in high-risk patients undergoing elective major abdominal surgery.
This multicenter, single-blind, superiority randomized clinical trial enrolled high-risk patients undergoing elective major abdominal surgery between October 8, 2023, and October 25, 2025, at 12 university medical centers in Austria, the Czech Republic, Denmark, Germany, and Spain. The date of last follow-up was January 15, 2026.
Patients were randomized to individualized cardiac index-guided hemodynamic therapy targeting the patient's preoperative resting cardiac index vs routine hemodynamic therapy (with blinded cardiac index monitoring).
The primary outcome was a composite of acute kidney injury, acute myocardial injury, severe infectious complications, nonfatal cardiac arrest, or death within the first 7 postoperative days. Secondary outcomes included the individual components of the primary outcome within the first 7 postoperative days.
Of the 1128 patients enrolled, 1111 were randomized and 1095 were included in the primary analysis (median age, 67 years [IQR, 59-74 years]; 49.4% were female). The primary outcome occurred in 243 of 549 patients (44.3%) in the individualized cardiac index-guided hemodynamic therapy group vs 256 of 546 patients (46.9%) in the routine hemodynamic therapy group (relative risk, 0.94 [95.1% CI, 0.83-1.08]; P = .38). There were no between-group differences for the incidence of the individual components of the primary outcome within the first 7 postoperative days.
Among high-risk patients undergoing elective major abdominal surgery, individualized cardiac index-guided hemodynamic therapy targeting the patient's preoperative resting cardiac index did not reduce the incidence of a composite outcome of acute kidney injury, acute myocardial injury, severe infectious complications, nonfatal cardiac arrest, or death within the first 7 postoperative days compared with routine hemodynamic therapy.
ClinicalTrials.gov Identifier: NCT05648279.

PMID:
42896534
Bibliographic data and abstract were imported from PubMed on 20 Oct 2026.

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