Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05898269
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2023-06-01
Brief Title:
Fluid Responsiveness Prediction During Prone Position
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Evaluation of the Diagnostic Performance of 4 Dynamic Tests Evaluating Preload Dependence in Patients With Acute Respiratory Distress Syndrome in the Prone Position
Status:
RECRUITING
Status Verified Date:
2024-01
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:
PROLOAD
Brief Summary:
Predicting fluid responsiveness is primordial when caring for patients with circulatory shock as it allows correction of preload-dependent low cardiac output states while preserving patients of the deleterious effects of excessive fluid resuscitation
Patients with severe acute respiratory distress syndrome ARDS treated with prone positioning PP are a specific subset of patients as 1 they frequently present with shock 2 excessive fluid administration may lead to respiratory worsening due to increased hydrostatic oedema with potential subsequent worse clinical outcome and 3 all available dynamic tests evaluating fluid responsiveness can only be performed in patients in the supine condition which in the case of severe ARDS patients in PP occurs only for 8h over 24h These elements warrant the development of specific tests allowing the clinician to predict fluid responsiveness with enough exactitude when caring for these patients
We hypothesize that there exists diagnostic heterogeneity in the predictive performance of 4 clinical tests to identify fluid responsiveness in ARDS patients in PP For the matter of this study these 4 tests are the Trendelenburg maneuver the end-expiratory occlusion test the end-expiratory occlusion test associated with the end-inspiratory occlusion test and the tidal volume challenge The diagnostic reference of the study will be the relative change in cardiac index measured by transpulmonary thermodilution before and after a 500 ml fluid bolus and will allow the adjudication of patients as being fluid responsive or not
The primary objective of the study is to determine the area under the ROC curve of each of the 4 tests with their respective 95 confidence interval
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence separated by 1-min wash-out periods with return to hemodynamic baseline values and concluded with the 500-ml fluid bolus Patients will only participate once The expected duration of study participation is 30 minutes maximum
Patients with severe acute respiratory distress syndrome ARDS treated with prone positioning PP are a specific subset of patients as 1 they frequently present with shock 2 excessive fluid administration may lead to respiratory worsening due to increased hydrostatic oedema with potential subsequent worse clinical outcome and 3 all available dynamic tests evaluating fluid responsiveness can only be performed in patients in the supine condition which in the case of severe ARDS patients in PP occurs only for 8h over 24h These elements warrant the development of specific tests allowing the clinician to predict fluid responsiveness with enough exactitude when caring for these patients
We hypothesize that there exists diagnostic heterogeneity in the predictive performance of 4 clinical tests to identify fluid responsiveness in ARDS patients in PP For the matter of this study these 4 tests are the Trendelenburg maneuver the end-expiratory occlusion test the end-expiratory occlusion test associated with the end-inspiratory occlusion test and the tidal volume challenge The diagnostic reference of the study will be the relative change in cardiac index measured by transpulmonary thermodilution before and after a 500 ml fluid bolus and will allow the adjudication of patients as being fluid responsive or not
The primary objective of the study is to determine the area under the ROC curve of each of the 4 tests with their respective 95 confidence interval
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence separated by 1-min wash-out periods with return to hemodynamic baseline values and concluded with the 500-ml fluid bolus Patients will only participate once The expected duration of study participation is 30 minutes maximum
Detailed Description:
None
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 |
|---|---|---|---|
| 2023-A00920-45 | OTHER | ANSM | None |