Echocardiographic Evaluation of RV Injury in the ICU
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
The adequate characterization of RV injury is currently unknown. The hypothesis is that the best characterization of RV injury is the one with the most significant impact on the response to fluids and on the outcome. An RV failure is expected to induce fluid-unresponsiveness and potentially worst outcome.
The main objective is to characterize different types of RV injury in critically ill patients by examining their association, including predictive performances, in hemodynamics parameters, ventilation parameters, and clinical outcomes
The study will be based on the realisation of an echocardiography within 48 hours following inclusion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients admitted to intensive care unit
With a central venous catheter inserted in the superior vena cava territory or a pulmonary arterial catheter for their management,
Requiring invasive ventilation, and/or catecholamine infusion.
Disqualifiers
Advanced chronic heart failure,
Planned or unplanned surgery including cardiac,
Advanced cancer,
Child C cirrhosis,
Trial population
Patients admitted in the ICU for circulatory and/or respiratory failure.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Echocardiography and central venous pressure
Diagnostic testTo perform an echocardiography, transthoracic or transesophageal and to measure central venous pressure through a central venous line.
Treatment groups
440 Participants
are divided into 1 treatment groupGroup A: Critically-ill patients1 intervention
Trial outcomes
Primary outcomes
1
Classification performance of selected haemodynamic parameters, ventilation parameters and biomarkers in different types of right ventricular injuries
Comparisons of classification performance for each model using a composite classification metrics consisting of R2, prediction accuracies, AUC and F1 scores.
Time frame
Through study completion, an average of 1 year.2
Association of the three different types of RV injury with ICU mortality
Odds ratios
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
Percentage of the 3 types of RV injuries
Percentage
Time frame
Through study completion, an average of 1 year2
Differentiating fluid responders from non-responders using different combinations of RV/LV EDA and CVP
The optimal combined cutoff values
Time frame
Through study completion, an average of 1 year3
The cutoff values of TAPSE, FAC and S' that best predict clinical outcomes
Cutoff values for TAPSE, FAC and S'
Time frame
Through study completion, an average of 1 year4
Prediction performance of three types of RV injury for fluid responsiveness.
Comparisons of predicted classes with true classes
Time frame
Through study completion, an average of 1 yearLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: