Clinical Trials Logo

Clinical Trial Summary

Shock is a serious complication corresponding to acute circulatory failure resulting in multiorgan failure and death. In order to improve cellular oxygen utilization, several therapies can be used. To select one of them, the monitoring of cardiac output is helpful. However, there are several methods used in current practice in intensive care for evaluating hemodynamic. Currently, in patients with acute circulatory failure, no study has compared the concordance of therapeutic decision-making based on transpulmonary thermodilution or transthoracic echocardiography. The objective of the PICC-ECHO study is thus to assess the concordance of therapeutic decision-making by several experts, based on data from transpulmonary thermodilution or transthoracic echocardiography. Indeed, the investigators hypothesize that performing hemodynamic monitoring based on transpulmonary thermodilution or transthoracic echocardiography does not lead to the same therapeutic management in patients in shock.


Clinical Trial Description

PICC-ECHO is a monocentric, prospective, non interventional, exploratory study to assess the concordance of therapeutic decision-making between two strategies used in current practice, transthoracic echocardiography and transpulmonary thermodilution, in patients with acute circulatory failure. Each patient in shock with cardiac output monitoring by transpulmonary thermodilution is identified and then eligible for inclusion. After inclusion, measurements of cardiac output with PICCO device and transthoracic echocardiography will be performed before and after a passive leg raising test and a respiratory occlusion test if patient are under invasive mechanical ventilation. These assessments will be conducted by two different investigators, to be sure that data by transthoracic echocardiography will not be influenced by the measurements collected by the analysis of the transpulmonary thermodilution. Clinical, biological, echocardiographic and transpulmonary thermodilution data will be then collected on a database. The therapeutic management of the clinicianresponsible for the patient will also be collected. The database will be used as support for the drafting of three medical observations for each patient on an electronic CRF : one with data from transpulmonary thermodilution, one with data from transthoracic echocardiography, and one with only clinico-biological parameters (without advanced monitoring). At the end, 45 different files will be compiled and submitted to different intensive care physicians (between 10 and 20) working outside the investigative team (" experts "). In order to avoid any recognition between the three versions of a same patient, the investigators will undergo a semantic variation and the mailings will be done in three distinct groups corresponding to the three methods separated by a few weeks. For each clinical case, experts will have to choose about the following choices: volume expansion, increase norepinephrine, introduction or increase dobutamine, abstention with continuation of current therapy. Vital status of the patient as well as the use of supportive care (mechanical ventilation, renal-replacement therapy, vasoactive drug, other assistance) and their duration will be collected at day n°28. For each case, the investigators will evaluate the concordance of decision of each expert, depending on whether the informations was collected by PICCO device, by echocardiography or without invasive monitoring. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05613647
Study type Observational [Patient Registry]
Source University Hospital, Angers
Contact Nicolas FAGE, MD
Phone 0241355865
Email nicolas.fage@chu-angers.fr
Status Recruiting
Phase
Start date December 13, 2022
Completion date January 2025

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05898126 - Renin-guided Hemodynamic Management in Patients With Shock N/A
Completed NCT05563701 - Evaluation of the LVivo Image Quality Scoring (IQS)
Recruiting NCT05066256 - LV Diastolic Function vs IVC Diameter Variation as Predictor of Fluid Responsiveness in Shock N/A
Not yet recruiting NCT06285513 - Cardiovascular Metabolic Remodeling in Shock
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Terminated NCT02755155 - Optimization of Therapeutic Human Serum Albumin Infusion in Selected Critically Ill Patients Phase 4
Not yet recruiting NCT01941472 - Transcutaneous pO2, Transcutaneous pCO2 and Central Venous pO2 Variations to Predict Fluid Responsiveness N/A
Completed NCT01680783 - Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure N/A
Terminated NCT01696175 - PICU Admission Lactate and Central Venous Oxymetry Study N/A
Recruiting NCT01157299 - Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO N/A
Recruiting NCT01174966 - Assessment of Transcutaneous Oxygen Tension/Oxygen Challenge Test in Intensive Care Unit (ICU) Patients N/A
Completed NCT00743522 - Programming Implantable Cardioverter Defibrillators in Patients With Primary Prevention Indication
Completed NCT03296891 - Point of Care Ultrasonography In The Management of Shock: A Pilot Study N/A
Recruiting NCT05922982 - Norepinephrine Weaning Guided by the Hypotension Prediction Index in Vasoplegic Shock After Cardiac Surgery N/A
Withdrawn NCT04705701 - Comparing Post Cardiac Surgery Outcomes in ESRD Patient's With Early Dialysis Versus Standard Care N/A
Recruiting NCT04615065 - Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine
Completed NCT05330676 - Evaluation of Microcirculatory Function and Mitochondrial Respiration After Cardiovascular Surgery
Active, not recruiting NCT04079829 - Postoperative Respiratory Abnormalities
Completed NCT04089098 - VOLume and Vasopressor Therapy in Patients With Hemodynamic instAbility
Completed NCT03190408 - Variation in Fluids Administered in Shock