Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
10 participants
OBSERVATIONAL
2021-01-25
2021-08-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Pneumatic Intermittent Venous Compression on Fluid Volumes Infused During Major Abdominal Surgery
NCT01403909
Hemodynamic Response During Goal Directed Fluid Therapy in the OR
NCT02365688
In Situ Exploration of Vascular Function in Vasoplegic Shock Following Cardiac Surgery With Cardiopulmonary Bypass
NCT06318689
Reliability of a New Pulse Contour Technique for Diagnosing an Increase in Stroke Volume During a Fluid Challenge for Hemodynamic Optimization in Patients Scheduled for High-risk Abdominal Surgery: Comparison With Transthoracic Echocardiography: COMPARE Study
NCT04871620
Correlation Between ΔPP/HR and ΔSV During Fluid Challenge.
NCT02439242
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
When PPV or SVV is above 13%, the patient will usually respond to a bolus of fluid while when PPV or SVV is below 9%, the patient will normally not respond to it. Between 9% and 13%, it is a gray zone where the effect of a fluid bolus is uncertain.
The overall goal of fluid bolus administration is of course to optimize macrocirculation (stroke volume and cardiac output) but also (and probably more importantly) end organ tissue perfusion. However, regional tissue perfusion is not widely monitored during surgery. However, we do have some monitoring tools to assess microcirculation at the bedside.
Investigation of microcirculation in addition to macro circulation may allow clinicians to know if a patient situated in the gray zone may or not increase microcirculation variables while macrocirculation variables are well known to be of little value to predict fluid responsiveness.
The goal of this study is to assess microcirculation variables in patients situated in the gray zone (PPV between 9%-13%), and to assess macro and microcirculation responses to a standardized fluid challenge of 4 ml/kg of a balanced crystalloid solution.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fluid challenge
fluid challenge administration when patient is in the gray zone
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients equipped with a minimally invasive cardiac output monitoring device in order to optimize fluid administration
Exclusion Criteria
* Ejection fraction \<40%
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Erasme University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Alexandre Joosten, MD PhD
Study Director
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alexandre JOOSTEN, MD PhD
Role: STUDY_DIRECTOR
ERASME
Alexandra Colesnicenco, MD
Role: PRINCIPAL_INVESTIGATOR
ERASME
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bicetre hospital
Le Kremlin-Bicêtre, Val De Marne, France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P2020/338 / B4062020000092
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.