Respiratory Variations for Predicting Fluid Responsiveness
France90 participantsStarted 2011-11
Plain-language summary
Hypovolemia and acute circulatory failure affects more than 60% of patients hospitalized in intensive care or resuscitation. The volume expansion (VE) by fluid replacement therapy is the first treatment improve circulatory function. However, too much VE can be harmful. So, the use of dynamic predictive indicators of fluid responsiveness is recommended in patients with sepsis.In patients with spontaneous ventilation, few studies have evaluated these parameters. In mechanical ventilation, indices based on the respiratory variation of the diameters of vena cava have been studied and validated to predict the response to VE. However there is no similar study in spontaneously breathing patients without ventilatory support. The investigators hypothesize that the respiratory variations in the IVC diameters and femoral artery flow during standardized respiratory cycles are predictive factors of fluid responsiveness in spontaneously breathing patients with sepsis, acute circulatory failure, and regular cardiac rhythm.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients of the intensive care units of the Lille university-hospital and of the Valenciennes general hospital.
* Age greater than or equal to 18.
* Patient insured
* Spontaneous breathing without ventilatory support or intubation or tracheotomy.
* Regular cardiac rhythm
* Prescription by the physician in charge of the patients of a 500 mL volume expansion in less than 30 minutes.
* Patients with sepsis with at least one sign of acute circulatory failure:
* Tachycardia with heart rate\> 100/min
* systolic blood pressure \<90mmHg or a decrease \>40mmHg in previously hypertense patient
* Oliguria \<0.5ml/kg/hour for at least one hour
* skin mottling
Exclusion Criteria:
* high-grade aortic insufficiency
* transthoracic echogenicity unsuitable for measuring the stroke volume or inferior vena cava diameters
* clinical signs of active exhalation
* clinical or ultrasonographic evidence of pulmonary edema due to heart failure
* pregnancy
* abdominal compartment syndrome
* Irregular cardiac rhythm
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
"respiratory variations in inferior vena cava diameters" with respect to the response to fluid resuscitation, assessed by the area under the ROC curve
Timeframe: during 30 minutes of the volume expansion