- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02899897
Place of Echocardiography in IV Fluid Therapy in Patients With Septic Shock and Left Ventricular Systolic Dysfunction (DYSPRED)
July 17, 2020 updated by: Centre Hospitalier Universitaire, Amiens
Place of Echocardiography in IV Fluid Therapy in Patients With Septic Shock and Left Ventricular Systolic Dysfunction: a Multicentre Prospective Study
IV fluid therapy remains an essential haemodynamic objective in the treatment strategy of septic shock.
Left ventricular systolic dysfunction secondary to sepsis is observed in 40% and up to 65% of the population concerned.
However, the capacity of the various indices to predict the response to IV fluid therapy in septic shock with left ventricular systolic dysfunction have not been clearly defined.
Measurement of parameters reflecting filling pressures during transthoracic echocardiography (TTE) is one of the methods used to evaluate cardiac function and estimate the filling reserve, but with no strong evidence.
Right heart catheterization with determination of cardiac output by pulmonary thermodilution can also be used to measure the various parameters commonly used to predict the response to IV fluid therapy.
Very few data are available with no reliable and clinically relevant data in this population with septic shock and left ventricular systolic dysfunction (LVEF ≤ 40%) and the response to IV fluid therapy monitored by dynamic indices obtained by transpulmonary thermodilution and right heart catheterization.
Consequently, the capacity of the various indices of preload dependence to predict the response to IV fluid therapy in septic shock with left ventricular systolic dysfunction remains difficult to define.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Amiens, France, 80054
- CHU Amiens
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with septic shock.
Description
Inclusion Criteria:
- Septic shock with cardiovascular dysfunction despite norepinephrine,
- Left ventricular systolic dysfunction defined by transthoracic echocardiography and LVEF ≤ 40%
- Fluid challenge decided by the patient's attending physician according to the optimization of cardiac output in septic shock protocol,
- IV fluid therapy with 500 ml of crystalloid solution.
- Haemodynamic monitoring decided by the patient's referring physician not involved in the study, according to the department's usual practice by transthoracic echocardiography and thermodilution monitoring.
- Sedated, on mechanical ventilation, and adapted to the ventilator.
- Patients who have received oral information and written documentation (with a copy filed in the medical records) on awakening.
- The trusted person designated for each patient has received the same oral and written information.
Exclusion Criteria:
Patients under the age of 18 years, pregnant women, patients under judicial protection or deprived of their freedom, Amputation of one or both lower limbs Contraindication to passive leg raising (e.g.: severe IC, etc.), Cardiac tamponade or aortic dissection with uncontrolled active bleeding. No indication for IV fluid therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response to IV fluid therapy
Time Frame: 90 minutes
|
defined by an increase in stroke volume by more than 15% of its baseline value measured by thermodilution.
|
90 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2016
Primary Completion (ACTUAL)
September 1, 2018
Study Completion (ACTUAL)
September 1, 2018
Study Registration Dates
First Submitted
September 5, 2016
First Submitted That Met QC Criteria
September 8, 2016
First Posted (ESTIMATE)
September 14, 2016
Study Record Updates
Last Update Posted (ACTUAL)
July 20, 2020
Last Update Submitted That Met QC Criteria
July 17, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RNI2015-37 Dr Zogheib
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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