Perioperative Hemodynamic Optimization in Patients at Risk for Delirium - A Randomized-Controlled Trial

Abstract

Background: Post-operative delirium is common in elderly patients and associated with increased morbidity and mortality. We evaluated in this pilot study whether a perioperative goal-directed hemodynamic optimization algorithm improves cerebral oxygenation and can reduce the incidence of delirium.

Materials and methods: Patients older than 70 years with high risk for post-operative delirium undergoing elective non-cardiac surgery were randomized to an intervention or control group. Patients in the intervention group received a perioperative hemodynamic optimization protocol based on uncalibrated pulse-contour analysis. Patients in the control group were managed according to usual standard of care. Incidence of delirium until day seven was assessed with confusion assessment method (CAM) and chart review. Cerebral oxygenation was measured with near-infrared spectroscopy.

Results: Delirium was present in 13 of 85 (15%) patients in the intervention group and 18 of 87 (21%) in the control group [risk difference -5.4%; 95% confidence interval, -16.8 to 6.1%; P = 0.47]. Intervention did not influence length of stay in hospital or in-hospital mortality. Amounts of fluids and vasopressors applied, mean arterial pressure, cardiac index, and near-infrared spectroscopy values were comparable between groups.

Conclusion: The hemodynamic algorithm applied in high-risk non-cardiac surgery patients did not change hemodynamic interventions, did not improve patient hemodynamics, and failed to increase cerebral oxygenation. An effect on the incidence of post-operative delirium could not be observed.

Clinical trial registration: [Clinicaltrials.gov], identifier [NCT01827501].

Keywords: frailty; goal-directed hemodynamic monitoring; goal-directed therapy; outcome; post-operative delirium.

Conflict of interest statement

BJ received honoraria for giving lectures from Pulsion Medical Systems SE (Feldkirchen, Germany). MB received research support from MSD (Haar, Germany) not related to this manuscript, received honoraria for giving lectures from GE Healthcare (Helsinki, Finland) and Grünenthal (Aachen, Germany). SJS reports grants from Reactive Robotics GmbH (Munich, Germany), grants and non-financial support from STIMIT AG (Biel, Switzerland), Liberate Medical LLC (Crestwood USA), ESICM (Geneva, Switzerland), grants, personal fees and non-financial support from Fresenius Kabi Deutschland GmbH (Bad Homburg, Germany), personal fees from Springer Verlag GmbH (Vienna, Austria) for educational purposes, non-financial support from Technical University of Munich (Munich, Germany) and from National and international societies (and their congress organizers) in the field of anesthesiology and intensive care medicine, outside the submitted work. SJS held stocks in small amounts from Rhön-Klinikum AG and holds stocks in small amounts from Alphabeth Inc., Bayer AG and Siemens AG; these holdings have not affected any decisions regarding his research or this study. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Fuest, Servatius, Ulm, Schaller, Jungwirth, Blobner and Schmid.

Figures

FIGURE 1

Hemodynamic treatment algorithm in the intervention group. The hemodynamic goals were mean arterial pressure (MAP) >70 mmHg and a cardiac index (CI) >2.5 L/kg/m2. Hemodynamics were evaluated routinely every 30 min, as well as at times of hemodynamic instability. We tested fluid responsiveness using a volume challenge of 250 mL Ringer’s acetate. Depending on changes in the stroke volume index (SVI), the patient received either volume or catecholamines in a titrated manner.

FIGURE 2

CONSORT diagram.