Peripheral Perfusion Index Trajectory to Predict 28-Day Mortality in Patients With Sepsis in the Intensive Care Unit
NCT07740304
Critical Illness, Disease Attributes
Edirne, Merkez, Turkey (Türkiye)
View Trial DetailsNCT Number: NCT06737614
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Hospital Do Coracao, São Paulo, Brazil
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
Primary Objective
Secondary Objectives
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 day
measured by bedside echocardiography
Time frame: 1 day
measured from invasive arterial line
Contact information is provided by the study sponsor or research team.
Eduardo Kattan, MD, PhD
CONTACT
Glenn Hernandez, MD, PhD
CONTACT
Pontificia Universidad Catolica de Chile
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07740304
Critical Illness, Disease Attributes
Edirne, Merkez, Turkey (Türkiye)
View Trial DetailsNCT07737353
Anxiety Disorders, Behavior
Giresun, Turkey (Türkiye)
View Trial DetailsNCT06728722
Atrophy, Critical Illness
Cairo, Cairo Governorate, Egypt
View Trial DetailsNCT07722897
Critical Illness, Disease Attributes
Antalya, Turkey (Türkiye)
View Trial Details