Clinical trial NCT06737614: Relationship Between Pulse Pressure and Stroke Volume in the Critically Ill Patients: The ANDROMEDA-PEGASUS Study
Official title: Can Pulse Pressure Assessment at the Bedside Detect Low Values or Track Changes of Stroke Volume in Critically Ill Patients? The Multicenter, Cross-sectional, Observational, ANDROMEDA-PEGASUS Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Illness
Keywords: pulse pressure
stroke volume
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
name: Fundacion Clinica Valle del Lili
name: Hospital do Coracao
First posted: 2024-12-17
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - During the study period (one or two weeks according to local study team), eligible patients will be identified during morning rounds. Consecutive patients which comply with inclusion and exclusion criteria and consent in participating will be included in the study. A broad range of ICU patients will be included to perform relevant subgroup analysis.

Brief summary: The goal of this study is to assess the predictive capacity of pulse pressure to estimate stroke volume, as assessed by bedside echocardiography in critically ill patients.

We hypothesize that pulse pressure will be able to adequately detect low values of stroke volume, and to track changes of stroke volume during commonly used dynamic cardiovascular interventions.

Pulse pressure transduced from an arterial line will be measured simultaneously with left ventricular outflow tract velocity time integral in a broad range of critically ill patients. Ancillary clinical, hemodynamic and echocardiographic data will also be registered.

Detailed description: Critically ill patients often present complex cardiovascular derangements that impair oxygen delivery to the tissues leading to progressive organ dysfunction. Monitoring tissue perfusion and identifying the predominant hemodynamic patterns are key clinical objectives to implement resuscitative strategies and revert this vicious cycle. However, in different stages of acute circulatory dysfunction at the emergency department (ED) or the intensive care unit (ICU), or resource-limited settings, initial resuscitative decisions may be taken with basic clinical information only. In addition, many therapeutic interventions in the ICU such as fluids, diuretics, vasoactive drugs, and ventilatory-related maneuvers, among others, may jeopardize stroke volume (SV) in different ways, a fact that may evolve undetected due to the absence of specific hemodynamic monitors in all patients.

Unfortunately, there is no simple, costless, and universally available clinical monitor to detect low SV. There have been, however, physiological implications to use blood pressure components as a surrogate for SV. Although pulse pressure (PP) has been observed to be largely determined by SV in experimental conditions, the key issues remain to be clarified: can PP monitoring at the bedside be useful to detect extreme values, or track changes, in underlying SV? Moreover, what are the limitations, the contexts, the technical aspects, among other factors, that can affect this relationship, and thus help clinicians to potentially use PP as an early warning signal or a trigger for initial resuscitative or therapeutic interventions?

From a clinical point of view, the most relevant question is if PP monitoring can detect a low SV so that corrective measures might be implemented, while more advanced confirmatory monitoring, including point-of-care ultrasound, is pending. In addition, what are the potential confounders for this assumption? If these questions are answered, this simple and costless tool may be used as a first-line approach for macrohemodynamic profiling and clinical decision-making, which could be especially valuable in resource-limited settings and in sites where ultrasound or advanced cardiac output monitoring is not immediately available. In this multicenter, observational, cross-sectional study, we aim at answering the following research question:

Research Question

* In critically ill patients, does pulse pressure, measured through an invasive arterial line, have an adequate predictive capacity to estimate stroke volume, as assessed by bedside echocardiography?
* We hypothesize that pulse pressure will be able to adequately detect low values of stroke volume, and to track changes of stroke volume during commonly used dynamic cardiovascular interventions.

Primary Objective

- To assess the predictive capacity of pulse pressure to detect low stroke volume, evaluated by bedside ultrasonography in critically ill patients.

Secondary Objectives

* To assess the predictive capacity of PP to detect low SV in different clinical contexts in ICU patients, such as in those with acute respiratory distress syndrome (ARDS), postoperative states, or septic shock, among others.
* To assess the impact of several demographic, clinical and technical issues on the predictive capacity of PP to estimate SV, such as mechanical ventilation, vasoactive medication, age, position of the arterial line, among others.
* To determine the capacity of PP to track changes of SV during common intensive care interventions such as passive leg raising (PLR) maneuver or fluid challenges.

Eligibility criteria: Inclusion Criteria:

* 18 years
* Admitted to ICU
* Functioning arterial line in place

Exclusion Criteria:

* Pregnancy
* Inadequate arterial line transduction (see below)
* Refusal of consent
* Patient who requires extracorporeal circulation

Primary outcomes:
measure: Left ventricular outflow tract velocity time integral
timeFrame: 1 day
measure: Pulse pressure
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital Do Coracao
city: Santiago
country: Chile
facility: Hospital Clinico UC Christus
city: Cali
country: Colombia
facility: Fundacion Valle del Lili
Study officials:
affiliation: Assistant Professor
name: Eduardo Kattan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Full Professor
name: Glenn Hernandez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bakker J, Kattan E, Annane D, Castro R, Cecconi M, De Backer D, Dubin A, Evans L, Gong MN, Hamzaoui O, Ince C, Levy B, Monnet X, Ospina Tascon GA, Ostermann M, Pinsky MR, Russell JA, Saugel B, Scheeren TWL, Teboul JL, Vieillard Baron A, Vincent JL, Zampieri FG, Hernandez G. Current practice and evolving concepts in septic shock resuscitation. Intensive Care Med. 2022 Feb;48(2):148-163. doi: 10.1007/s00134-021-06595-9. Epub 2021 Dec 15.
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