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The evolution of mean arterial pressure in critically ill patients on vasopressors before and during a trial comparing a specific mean arterial pressure target to usual care

In randomized clinical controlled trials, the choice of usual care as the comparator may be associated with better clinician uptake of the study protocol and lead to more generalizable results. However, if care processes evolve to resemble the intervention during the course of a trial, differences b...

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Published in:BMC anesthesiology 2022-01, Vol.22 (1), p.6-6, Article 6
Main Authors: Masse, Marie-Hélène, Adhikari, Neill K J, Théroux, Xavier, Battista, Marie-Claude, D'Aragon, Frédérick, Pinto, Ruxandra, Cohen, Alan, Mayette, Michaël, St-Arnaud, Charles, Kho, Michelle, Chassé, Michaël, Lebrasseur, Martine, Watpool, Irene, Porteous, Rebecca, Wilcox, M Elizabeth, Lamontagne, François
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container_title BMC anesthesiology
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creator Masse, Marie-Hélène
Adhikari, Neill K J
Théroux, Xavier
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Cohen, Alan
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St-Arnaud, Charles
Kho, Michelle
Chassé, Michaël
Lebrasseur, Martine
Watpool, Irene
Porteous, Rebecca
Wilcox, M Elizabeth
Lamontagne, François
description In randomized clinical controlled trials, the choice of usual care as the comparator may be associated with better clinician uptake of the study protocol and lead to more generalizable results. However, if care processes evolve to resemble the intervention during the course of a trial, differences between the intervention group and usual care control group may narrow. We evaluated the effect on mean arterial pressure of an unblinded trial comparing a lower mean arterial pressure target to reduce vasopressor exposure, vs. a clinician-selected mean arterial pressure target, in critically ill patients at least 65 years old. For this multicenter observational study using data collected both prospectively and retrospectively, patients were recruited from five of the seven trial sites. We compared the mean arterial pressure of patients receiving vasopressors, who met or would have met trial eligibility criteria, from two periods: [1] at least 1 month before the trial started, and [2] during the trial period and randomized to usual care, or not enrolled in the trial. We included 200 patients treated before and 229 after trial initiation. There were no differences in age (mean 74.5 vs. 75.2 years; p = 0.28), baseline Acute Physiology and Chronic Health Evaluation II score (median 26 vs. 26; p = 0.47) or history of chronic hypertension (n = 126 [63.0%] vs. n = 153 [66.8%]; p = 0.41). Mean of the mean arterial pressure was similar between the two periods (72.5 vs. 72.4 mmHg; p = 0.76). The initiation of a trial of a prescribed lower mean arterial pressure target, compared to a usual clinician-selected target, was not associated with a change in mean arterial pressure, reflecting stability in the net effect of usual clinician practices over time. Comparing prior and concurrent control groups may alleviate concerns regarding drift in usual practices over the course of a trial or permit quantification of any change.
doi_str_mv 10.1186/s12871-021-01529-w
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subjects Aged
Analysis
Arterial pressure
Arterial Pressure - drug effects
Blood pressure
Cardiac arrhythmia
Clinical trials
Control groups
Critical care
Critical Care - methods
Critical Illness
Female
Hospitals
Humans
Hypotension
Ischemia
Male
Medical records
Patients
Research design
Retrospective Studies
Variables
Vasoconstrictor agents
Vasoconstrictor Agents - administration & dosage
title The evolution of mean arterial pressure in critically ill patients on vasopressors before and during a trial comparing a specific mean arterial pressure target to usual care
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