Dataset Information

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.

ABSTRACT:

Background

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.

Methods

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.

Results

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).

Conclusions

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.

SUBMITTER: Masse MH

PROVIDER: S-EPMC8722048 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundIncreased or decreased blood pressure variability may affect the perfusion of tissues and organs, leading to acute kidney injury and death. This study was conducted to explore the relationship between mean arterial pressure variability and short- and long-term mortality in critically ill patients.MethodsWe used patient data from the MIMIC-III database for cohort study. According to the recorded mean arterial pressure during the first 24 h in the intensive care unit, we calculated each patient's two variability parameters -coefficient of variation and average real variability. The primary outcome was in-hospital mortality and the secondary outcomes were 28-day mortality and 1-year mortality. We conducted smooth spline models to examine the possible nonlinear associations between blood pressure variability and mortality. According to the smoothing curve, we further developed a two-piecewise linear regression model to find out the threshold effect. Multivariable logistic regression or Cox proportional hazards model was used to evaluate the relationship. Kaplan-Meier survival analysis for 28-day and 1-year mortality was performed. Subgroup analysis explored the factors modifying the relationship between them.ResultsA total of 12,867 patients were enrolled in the study, 1,320 in-hospital death, 1,399 28-day death, and 2,734 1-year death occurred. The smooth spline showed death risk was the lowest when average real variability was around 7.2 mmHg. After adjusting for covariates, logistic or Cox regression showed the highest MAP variability level was strongly associated with increased mortality in the hospital (odds ratio: 1.44; 95% CI, 1.21∼1.72), at 28 days (hazard ratio: 1.28; 95% CI, 1.1∼1.5), and at 1 year (hazard ratio: 1.27; 95% CI, 1.14∼1.42) compared with the second level of average real variability group. The survival curve plot showed patients with higher average real variability had a higher risk of 28-day and 1-year mortality. This relationship remained remarkable in patients with low or high Sequential Organ Failure Assessment scores in the sensitivity analysis. The two-piecewise linear regression model showed that lower ARV was a risk factor for 28-day (HR 0.72, 95% CI, 0.57∼0.91) and 1-year mortality (HR 0.81, 95% CI, 0.68∼0.96) when ARV was less than 7.2 mmHg, higher ARV was a risk factor for 28-day mortality (HR 1.1, 95% CI, 1.04∼1.17) and 1-year mortality (HR 1.07, 95% CI, 1.02∼1.12) when ARV was greater than 7.2 mmHg.ConclusionBlood pressure variability predicts mortality in critically ill patients. Individuals with higher or lower mean arterial pressure average real variability during the first day in ICU may have an increased risk of death.

Project description:BackgroundOne of the main goals of cardiopulmonary bypass (CPB) is targeting an adequate mean arterial pressure (MAP) during heart surgery, in order to maintain appropriate perfusion pressures in all end-organs. As inheritance of early studies, a value of 50-60 mmHg has been historically accepted as the "gold standard" MAP. However, in the last decades, the CPB management has remarkably changed, thanks to the evolution of technology and the availability of new biomaterials. Therefore, as highlighted by the latest European Guidelines, the current management of CPB can no longer refer to those pioneering studies. To date, only few single-centre studies have compared different strategies of MAP management during CPB, but with contradictory findings and without achieving a real consensus. Therefore, what should be the ideal strategy of MAP management during CPB is still on debate. This trial is the first multicentre, randomized, controlled study which compares three different strategies of MAP management during the CPB.MethodsWe described herein the methodology of a multicentre, randomized, controlled trial comparing three different approaches to MAP management during CPB in patients undergoing elective cardiac surgery: the historically accepted "standard MAP" (50-60 mmHg), the "high MAP" (70-80 mmHg) and the "patient-tailored MAP" (comparable to the patient's preoperative MAP). It is the aim of the study to find the most suitable management in order to obtain the most adequate perfusion of end-organs during cardiac surgery. For this purpose, the primary endpoint will be the peak of serum lactate (Lmax) released during CPB, as index of tissue hypoxia. The secondary outcomes will include all the intraoperative parameters of tissue oxygenation and major postoperative complications related to organ malperfusion.DiscussionThis trial will assess the best strategy to target the MAP during CPB, thus further improving the outcomes of cardiac surgery.Trial registrationNCT05740397 (retrospectively registered; 22/02/2023).

Project description:BackgroundMean perfusion pressure (MPP) has recently emerged as a potential biomarker for personalized management of tissue perfusion in critically ill patients. However, its association with the occurrence of acute kidney injury (AKI) in septic patients and the optimal MPP range remain uncertain. Therefore, this study aims to investigate the relationship between MPP and AKI in critically ill patients with sepsis.MethodsWe identified 5867 patients with sepsis from the MIMIC-IV database who met the inclusion and exclusion criteria. The exposure variable was the first set of MPP measured within 24 h after ICU admission with invasive hemodynamic monitoring. The primary outcome was the incidence of AKI at 7 days following ICU admission according to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. Secondary outcomes included in-hospital mortality, lengths of ICU, and hospital stay. Optimal cut-off point for MPP were determined using the Youden index, and multivariable logistic regression was employed to examine the association between MPP and AKI. Subgroup analyses were conducted to enhance result robustness. Kaplan-Meier survival analysis was utilized to evaluate in-hospital mortality rates categorized by MPP.ResultsA total of 5,867 patients with sepsis were included in this study, and the overall incidence of AKI was 82.3%(4828/5867). Patients were categorized into low MPP (< 63 mmHg) and high MPP (≥ 63 mmHg) groups using the optimal ROC curve-derived cut-off point. The incidence of AKI in the low MPP group was higher than that in the high MPP group (87.6% vs. 78.3%, P < 0.001). Multivariable logistic regression analysis adjusted for confounding factors revealed that each 1 mmHg increase in MPP as a continuous variable was associated with a 2% decrease in AKI incidence within 7 days of ICU admission (OR:0.98, 95%CI:0.97-0.99, P < 0.001). When MPP was used as a categorical variable, patients in the high MPP group had a lower risk of AKI than those in the low MPP group (OR:0.71, 95%CI:0.61-0.83, P = 0.001). Subgroup analyses demonstrated a consistent association between MPP and AKI risk across all variables assessed (P for interaction all > 0.05). Kaplan-Meier curve analysis demonstrated a higher survival rate during hospitalization in the high MPP group compared to the low MPP group (Log-rank test, P < 0.0001).ConclusionsLower levels of MPP are associated with an increased incidence of AKI at 7 days in critically ill patients with sepsis.