Individualized Cardiac Index–Guided Hemodynamic Therapy in High-Risk Patients Undergoing Elective Major Abdominal Surgery
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, , Linda Grüßer, Jan Larmann, Wiam Khader, Laima Balasova, Volker Huge, Anders P.H. Karlsen, Louise B. Kiel, Tobias L. Wulff, Mikael R. Henriksen, Rasmus B. Müller, Karin Graeser, Abdellatif El-Ahmadi, Marlene Søgaard, Melkorka Nørgaard, Mia L. Jepsen, Øivind Jans, Morten Bundgaard, Troels Munch, Mette Dam, Jakob Højlund, Line Stendell, Ulrik Ieppsen, Josefine U. Melchiorsen, Till L. Christiansen, René M'Pembele, Vlad Bucur, Theresa Tenge, Paula Bartholomäus, Marlene Zollner, Thomas Boessner-Weiss, Moritz Bünsch, Roland Dahlem, Margit Fisch, Gillis Greiwe, Thilo Hackert, Phillip Hoppe, Linda Krause, Fynn Meyer, Parisa Moll-Khosrawi, Felix Nickel, Anna Nießen, Susanne Reuter, Barbara Schmalfeldt, Leonie Schulte-Uentrop, Kaja Marie Wulschläger, Fabian Zambiasi, Moritz Steinhaus, Carla Nau, Silke Olsson, Marie-Luise Franz, Benjamin Vojnar, Tilo Koch, Saskia Haberl, Max Kult, Florian Brandes, Sebastian Niedermaier, Anna Trebo, Bernhard Zwißler, Phillip Groene, Ludwig Lamm, Elena Berg, Robert Bischoff, Alexander Burges, Friederike Hagemann, Sven Mahner, Juliane Reichenbach, Fabian Trillsch, Ulrich Wirth, Jens Werner, Bernhard Renz, Joachim Andrassy, Hanno Nieß, Markus Guba, Iñigo Rubio, Pablo Montero, Carmen Sala, Rafael Moncada, Jan Benes, Jan Zatloukal, Kristina SikulovaImportance
It remains unclear if intraoperative hemodynamic therapy should be guided by cardiac index.
Objective
To evaluate whether individualized cardiac index–guided hemodynamic therapy vs routine hemodynamic therapy improves outcomes in high-risk patients undergoing elective major abdominal surgery.
Design, Setting, and Participants
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.
Interventions
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).
Main Outcomes and Measures
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.
Results
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.
Conclusions and Relevance
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.
Trial Registration
ClinicalTrials.gov Identifier: