Robust K-PD model for activated clotting time prediction and UFH dose individualisation during cardiopulmonary bypass.


Journal

Computer methods and programs in biomedicine
ISSN: 1872-7565
Titre abrégé: Comput Methods Programs Biomed
Pays: Ireland
ID NLM: 8506513

Informations de publication

Date de publication:
Feb 2022
Historique:
received: 15 06 2021
revised: 17 11 2021
accepted: 24 11 2021
pubmed: 10 12 2021
medline: 28 1 2022
entrez: 9 12 2021
Statut: ppublish

Résumé

Activated clotting time (ACT) is a point-of-care test used to monitor the effect of unfractionated heparin (UFH) during cardiopulmonary bypass (CPB). This test sometimes returns aberrant values, which can lead to the administration of an inappropriate dosing regimen. The development of a population-robust K-PD model of UFH could allow the individualisation and automation of UFH therapy during CPB. We conducted a prospective observational study to collect ACT measurements from patients undergoing surgery using CPB. The ACT data were split into a development and validation cohort. The development cohort was used to estimate a standard and robust population K-PD model characterised by a residual error following a normal distribution and student's t-distribution. The ACT prediction performance using Bayesian estimates of individual K-PD parameters was evaluated by comparing predicted versus observed ACTs. Using estimates of the robust K-PD model, a Bayesian individualisation strategy to automate UFH administration was proposed and evaluated using Monte Carlo simulations. A total of 295 patients were included in the study, and 1561 ACTs were collected. In patients without outlier values, Bayesian estimates (based on four ACT measurements) from both standard and robust K-PD models had similar performances, with a median prediction bias close to 0 s. In patients with outlier measurements, the use of the robust K-PD model greatly improved the prediction bias and root-mean-square error (RMSE), with a mean prediction bias of 3.25 s, IQR = [-19.9; 46.03] versus -86 s IQR = [-135.7; -63.8] for the standard model. Monte Carlo simulations showed that the robust Bayesian individualisation strategy allowed the ACT to be maintained above the target using only two to three ACT measurements. The use of a robust K-PD model reduced prediction bias and RMSE in patients with outlier ACT measurements. The Bayesian individualisation strategy using robust estimates of individual parameters may help automate UFH dosing regimens. Proper clinical validation is warranted before its use in daily clinical practice.

Sections du résumé

BACKGROUND AND OBJECTIVE OBJECTIVE
Activated clotting time (ACT) is a point-of-care test used to monitor the effect of unfractionated heparin (UFH) during cardiopulmonary bypass (CPB). This test sometimes returns aberrant values, which can lead to the administration of an inappropriate dosing regimen. The development of a population-robust K-PD model of UFH could allow the individualisation and automation of UFH therapy during CPB.
METHODS METHODS
We conducted a prospective observational study to collect ACT measurements from patients undergoing surgery using CPB. The ACT data were split into a development and validation cohort. The development cohort was used to estimate a standard and robust population K-PD model characterised by a residual error following a normal distribution and student's t-distribution. The ACT prediction performance using Bayesian estimates of individual K-PD parameters was evaluated by comparing predicted versus observed ACTs. Using estimates of the robust K-PD model, a Bayesian individualisation strategy to automate UFH administration was proposed and evaluated using Monte Carlo simulations.
RESULTS RESULTS
A total of 295 patients were included in the study, and 1561 ACTs were collected. In patients without outlier values, Bayesian estimates (based on four ACT measurements) from both standard and robust K-PD models had similar performances, with a median prediction bias close to 0 s. In patients with outlier measurements, the use of the robust K-PD model greatly improved the prediction bias and root-mean-square error (RMSE), with a mean prediction bias of 3.25 s, IQR = [-19.9; 46.03] versus -86 s IQR = [-135.7; -63.8] for the standard model. Monte Carlo simulations showed that the robust Bayesian individualisation strategy allowed the ACT to be maintained above the target using only two to three ACT measurements.
CONCLUSIONS CONCLUSIONS
The use of a robust K-PD model reduced prediction bias and RMSE in patients with outlier ACT measurements. The Bayesian individualisation strategy using robust estimates of individual parameters may help automate UFH dosing regimens. Proper clinical validation is warranted before its use in daily clinical practice.

Identifiants

pubmed: 34883383
pii: S0169-2607(21)00627-1
doi: 10.1016/j.cmpb.2021.106553
pii:
doi:

Substances chimiques

Anticoagulants 0
Heparin 9005-49-6

Types de publication

Journal Article Observational Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

106553

Informations de copyright

Copyright © 2021 Elsevier B.V. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of Competing Interest There are no competing interests to declare.

Auteurs

Robin Chaux (R)

U1059, Dysfonction Vasculaire et Hémostase, INSERM, Saint-Etienne, France; Unité de Recherche Clinique, Innovation, Pharmacologie, Hôpital Nord, CHU de Saint-Etienne, Saint-Etienne Cedex 2, Saint-Etienne F-42055, France.

Julien Lanoiselée (J)

U1059, Dysfonction Vasculaire et Hémostase, INSERM, Saint-Etienne, France; Département d'Anesthésie-Réanimation, Hôpital Nord, CHU de Saint-Etienne, Saint-Etienne F-42055, France.

Clément Magand (C)

Département d'Anesthésie-Réanimation, Hôpital Nord, CHU de Saint-Etienne, Saint-Etienne F-42055, France.

Paul Zufferey (P)

U1059, Dysfonction Vasculaire et Hémostase, INSERM, Saint-Etienne, France; Département d'Anesthésie-Réanimation, Hôpital Nord, CHU de Saint-Etienne, Saint-Etienne F-42055, France.

Xavier Delavenne (X)

U1059, Dysfonction Vasculaire et Hémostase, INSERM, Saint-Etienne, France.

Edouard Ollier (E)

U1059, Dysfonction Vasculaire et Hémostase, INSERM, Saint-Etienne, France; Unité de Recherche Clinique, Innovation, Pharmacologie, Hôpital Nord, CHU de Saint-Etienne, Saint-Etienne Cedex 2, Saint-Etienne F-42055, France. Electronic address: edouard.ollier@univ-st-etienne.fr.

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Classifications MeSH