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Control of mean arterial pressure using a closed-loop system for norepinephrine infusion in severe brain injury patients: the COMAT randomized controlled trial

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Abstract

Brain injury patients require precise blood pressure (BP) management to maintain cerebral perfusion pressure (CPP) and avoid intracranial hypertension. Nurses have many tasks and norepinephrine titration has been shown to be suboptimal. This can lead to limited BP control in patients that are in critical need of cerebral perfusion optimization. We have designed a closed-loop vasopressor (CLV) system capable of maintaining mean arterial pressure (MAP) in a narrow range and we aimed to assess its performance when treating severe brain injury patients. Within the first 48 h of intensive care unit (ICU) admission, 18 patients with a severe brain injury underwent either CLV or manual norepinephrine titration. In both groups, the objective was to maintain MAP in target (within ± 5 mmHg of a predefined target MAP) to achieve optimal CPP. Fluid administration was standardized in the two groups. The primary objective was the percentage of time patients were in target. Secondary outcomes included time spent over and under target. Over the four-hour study period, the mean percentage of time with MAP in target was greater in the CLV group than in the control group (95.8 ± 2.2% vs. 42.5 ± 27.0%, p < 0.001). Severe undershooting, defined as MAP < 10 mmHg of target value was lower in the CLV group (0.2 ± 0.3% vs. 7.4 ± 14.2%, p < 0.001) as was severe overshooting defined as MAP > 10 mmHg of target (0.0 ± 0.0% vs. 22.0 ± 29.0%, p < 0.001). The CLV system can maintain MAP in target better than nurses caring for severe brain injury patients.

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Data availability

The datasets analyzed in this study are available from the corresponding author upon request.

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Acknowledgements

We wish to thank all ICU nurses and clinicians from Bicêtre Hospital for their support in this study.

Funding

Only departmental sources.

Author information

Authors and Affiliations

  1. Department of Anesthesiology & Perioperative Medicine, David Geffen School of Medicine, Ronald Reagan Medical Center, University of California Los Angeles, 757 Westwood Plaza, Los Angeles, CA, 90095, USA

    Alexandre Joosten & Maxime Cannesson

  2. Department of Anesthesiology & Perioperative Care, University of California Irvine, California, CA, 92868, USA

    Joseph Rinehart

  3. Department of Anesthesiology, Université Paris-Saclay, Hôpital Paul-Brousse, Assistance Publique Hôpitaux de Paris, Villejuif, France

    Sean Coeckelenbergh

  4. Outcomes Research Consortium, Cleveland, OH, USA

    Sean Coeckelenbergh

  5. Department of Intensive Care, Université Paris-Saclay, Hôpital Bicetre, Assistance Publique Hôpitaux de Paris, Le Kremlin Bicetre, France

    Jonas Pochard & Jacques Duranteau

  6. Unité de Recherche Clinique, Lariboisière University Hospital, Paris 7 Diderot University, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France

    Eric Vicaut

Authors
  1. Alexandre Joosten
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  7. Jacques Duranteau
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Contributions

All authors read and approved the final manuscript. AJ: Designed the study and the closed-loop system, recruited patients, collected and analyzed the data and drafted the manuscript. JR: Designed the closed-loop system, analyzed the data and edited the final manuscript. MC: Designed the closed-loop system, analyzed the data and edited the final manuscript. SC: Analyzed data, wrote and edited the manuscript. JP: Collected and analyzed the data and edited the manuscript. EV: Designed the study and edited the final manuscript. JD: Designed the study, collect and analyzed the data and edited the final manuscript.

Corresponding author

Correspondence to Alexandre Joosten.

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Conflict of interests

Maxime Cannesson, Alexandre Joosten, and Joseph Rinehart are consultants for Edwards Lifesciences, Irvine, CA, USA. Maxime Cannesson, Joseph Rinehart and Alexandre Joosten have ownership interest in Perceptive medical which has developed the studied closed-loop vasopressor system. The other authors declare that they have no conflicts of interest concerning this article. Edwards and Perceptive Medical provided no direct or indirect funding in support of the current work.

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Joosten, A., Rinehart, J., Cannesson, M. et al. Control of mean arterial pressure using a closed-loop system for norepinephrine infusion in severe brain injury patients: the COMAT randomized controlled trial. J Clin Monit Comput 38, 25–30 (2024). https://doi.org/10.1007/s10877-023-01119-w

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  • DOI: https://doi.org/10.1007/s10877-023-01119-w

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