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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A01702-43 | Other Identifier | ANSM |
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The main objective of this study is to evaluate in a population of patients with septic shock receiving 500 ml crystalloid over 10 minutes, the proportion of patients classified as "responders" to the fluid challenge (increase of at least 15% of ITV in aortic) at the end of vascular filling (T10) and becoming "non-responders" 20 minutes after the end of the fluid challenge (T30) and whether this proportion is greater than 10 points.
The secondary objectives of this study are :
A. To assess changes in different ultrasound parameters: E wave , E / A ratio , E / E ' in the event of vascular filling and construct a dose response curve for vascular filling.
B. To determing a threshold value for the mitral E wave velcoity that can predict a positive response to volume expansion at T10 defined by a 15% increase in the sub aortic velocity time integral (ITV) after 500 ml of crystalloids in 10 minutes.
C. To determine a threshold value for theITV at T0 that can predict a positive response to volume expansion at T10 defined by a 15% increase in the ITV after 500 ml of crystalloids in 10 minutes.
D. To evaluate the proportion of responders at T10 becoming non-responders at T20.
E. To evaluate the proportion of nonresponders at T10 and responders at T30 .
F. To estimate the proportion of patients changing status regardless of the direction of change between T10 and T30 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The study population | The study population consists of patients admitted to intensive care, sedated and under controlled ventilatory support with septic shock criteria defined by severe sepsis associated with hypotension despite fluid resuscitation of 20-40 ml / kg and requiring vascular filling according to the following criteria: oliguria <0.5 ml / kg / h for at least 2h skin mottling Arterial Lactate > 2 mmol / l SvcO2 <70% or SvO2 <65% Patient on noradrenaline. Severe sepsis is defined as a systemic inflammatory response associated with a suspected or proven infection and hypotension before filling, a lactate> 4 mmol / l or organ dysfunction. Intervention: Fluid challenge Intervention: Cardiac ultrasound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluid challenge | Procedure | The fluid challenge starts at minute 0 (T0) and consists of 500ml of crystalloids over 10 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient status changes from "responder" at the end of the fluid challenge (T10) to "non-responder" 20 minutes after the end of the fluid challenge (T30). | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Mitral E wave | Baseline (minute 0) | |
| Mitral E wave | 2 minutes | |
| Mitral E wave |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of patients admitted to intensive care, sedated and under controlled ventilatory support with septic shock criteria defined by severe sepsis associated with hypotension despite fluid resuscitation of 20-40 ml / kg and requiring vascular filling according to the following criteria:
Severe sepsis is defined as a systemic inflammatory response associated with a suspected or proven infection and hypotension before filling, a lactate> 4 mmol / l or organ dysfunction.
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| Name | Affiliation | Role |
|---|---|---|
| Claire Roger, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Amiens - Hôpital Nord | Amiens | 80054 | France | |||
| CHU de Besançon - Hôpital Jean Minjoz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31097012 | Result | Roger C, Zieleskiewicz L, Demattei C, Lakhal K, Piton G, Louart B, Constantin JM, Chabanne R, Faure JS, Mahjoub Y, Desmeulles I, Quintard H, Lefrant JY, Muller L; AzuRea Group. Time course of fluid responsiveness in sepsis: the fluid challenge revisiting (FCREV) study. Crit Care. 2019 May 16;23(1):179. doi: 10.1186/s13054-019-2448-z. |
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| Cardiac ultrasound | Procedure | Ultrasound measures are made at T0, T2, T4, T6, T8, T10, T20 and T30. |
|
| 4 minutes |
| Mitral E wave | 6 minutes |
| Mitral E wave | 8 minutes |
| Mitral E wave | 10 minutes |
| Mitral E wave | 20 minutes |
| Mitral E wave | 30 minutes |
| Mitral A wave | Baseline (minute 0) |
| Mitral A wave | 2 minutes |
| Mitral A wave | 4 minutes |
| Mitral A wave | 6 minutes |
| Mitral A wave | 8 minutes |
| Mitral A wave | 10 minutes |
| Mitral A wave | 20 minutes |
| Mitral A wave | 30 minutes |
| E' Wave at the lateral mitral annulus | Baseline (minute 0) |
| E' Wave at the lateral mitral annulus | 2 minutes |
| E' Wave at the lateral mitral annulus | 4 minutes |
| E' Wave at the lateral mitral annulus | 6 minutes |
| E' Wave at the lateral mitral annulus | 8 minutes |
| E' Wave at the lateral mitral annulus | 10 minutes |
| E' Wave at the lateral mitral annulus | 20 minutes |
| E' Wave at the lateral mitral annulus | 30 minutes |
| ITV | Baseline (minute 0) |
| ITV | 10 minutes |
| ITV | 20 minutes |
| ITV | 30 minutes |
| Patient status changes from "responder" at the end of the fluid challenge (T10) to "non-responder" 10 minutes after the end of the fluid challenge (T20). | 20 minutes |
| Patient status changes from "non-responder" at the end of the fluid challenge (T10) to "responder" 20 minutes after the end of the fluid challenge (T30). | 30 minutes |
| Besançon |
| 25030 |
| France |
| CHU de Caen - Hôpital Côte de Nacre | Caen | 14033 | France |
| CHU de Clermont Ferrand - Hôpital Estaing | Clermont-Ferrand | 63003 | France |
| CHU de Clermont Ferrand - Hôpital Gabriel-Montpied | Clermont-Ferrand | 63003 | France |
| APHM - Hôpital Nord | Marseille | 13915 | France |
| CHU de Nantes - Hôpital Guillaume et René Laennec | Nantes | 44093 | France |
| CHU de Nice - Hôpital St-Roch | Nice | 06001 | France |
| CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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