Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06286306
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2024-02-22
Brief Title:
Pronostic Value of Fluid Responsiveness Evaluated by Inferior Vena Cava Collapsibility Index in Patients Admitted in ICU With Acute Respiratory Failure
Sponsor:
University Hospital Lille
Organization:
University Hospital Lille
Study Overview
Official Title:
Pronostic Value of Fluid Responsiveness Evaluated by Inferior Vena Cava Collapsibility Index in Patients Admitted in ICU With Acute Respiratory Failure PRIVACY Study
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIVACY
Brief Summary:
Acute respiratory failure represents a frequent cause of admission to intensive care units ICUs In the absence of tailored interventions it poses an imminent threat to patients lives Most patients admitted in ICU undergo fluid expansion to enhance oxygen delivery and preserve cellular function
This practice is grounded in the concept of preload responsiveness However the accrual of positive fluid balance resulting from fluid administration is now acknowledged as an autonomous risk factor for mortality
Consequently preload unresponsiveness assumes a pathological character potentially indicative of fluid overload or right ventricular dysfunction both deleterious conditions linked to unfavorable outcomes
Maintaining patients in a preload-responsive state may be interesting to limit fluid expansion and the need of invasive mechanical ventilation
The objective of this prospective observational study is to evaluate the prognostic significance of preload responsiveness in patients admitted to the ICU with hypoxemic non-hypercapnic respiratory failure
Main objective To evaluate the association between fluid responsiveness assessed by the inferior vena cava collapsibility index cIVC with trans-thoracic echocardiography within the initial 48 hours post-ICU admission and mortality or the need for invasive mechanical ventilation by day 28 in patients admitted to the ICU for hypoxemic non-hypercapnic acute respiratory failure
Secondary objectives To evaluate the association between fluid responsiveness and mortality at day 28 and day 90 the need of invasive mechanical ventilation and the number of days free from organ support vasopressors mechanical ventilation and renal replacement therapy by day 28
Upon receipt of both oral and written information patients will provide non-objection to participate in the study This prospective single-center study has obtained approval from the Regional Ethics Committee of Ile de France III approval No 2022-A02813-40
This practice is grounded in the concept of preload responsiveness However the accrual of positive fluid balance resulting from fluid administration is now acknowledged as an autonomous risk factor for mortality
Consequently preload unresponsiveness assumes a pathological character potentially indicative of fluid overload or right ventricular dysfunction both deleterious conditions linked to unfavorable outcomes
Maintaining patients in a preload-responsive state may be interesting to limit fluid expansion and the need of invasive mechanical ventilation
The objective of this prospective observational study is to evaluate the prognostic significance of preload responsiveness in patients admitted to the ICU with hypoxemic non-hypercapnic respiratory failure
Main objective To evaluate the association between fluid responsiveness assessed by the inferior vena cava collapsibility index cIVC with trans-thoracic echocardiography within the initial 48 hours post-ICU admission and mortality or the need for invasive mechanical ventilation by day 28 in patients admitted to the ICU for hypoxemic non-hypercapnic acute respiratory failure
Secondary objectives To evaluate the association between fluid responsiveness and mortality at day 28 and day 90 the need of invasive mechanical ventilation and the number of days free from organ support vasopressors mechanical ventilation and renal replacement therapy by day 28
Upon receipt of both oral and written information patients will provide non-objection to participate in the study This prospective single-center study has obtained approval from the Regional Ethics Committee of Ile de France III approval No 2022-A02813-40
Detailed Description:
Video loops of the inferior vena cava IVC will be recorded during a transthoracic echocardiography performed for diagnostic purpose This method is routinely employed in our ICU to assess preload responsiveness in spontaneously breathing patients admitted for acute respiratory failure For study purposes IVC diameters will be measured remotely on anonymized recordings by operators blinded to patients outcomes The cIVC will be calculated at 4 cm from the IVC-right atrium junction using the following equation Maximum expiratory diameter - inspiratory diameter Maximum expiratory diameter
According to prior research conducted by our group Caplan et al Ann Intensive Care 2020 a cIVC 44 will be utilized to diagnose preload responsiveness
According to prior research conducted by our group Caplan et al Ann Intensive Care 2020 a cIVC 44 will be utilized to diagnose preload responsiveness
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-A02813-40 | OTHER | ID-RCB number ANSM | None |