Does the Time Between the End of Vascular Filling and Evaluation of Its Effectiveness Modify Fluid Challenge Results in Septic Shock?
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Septic Shock
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Enrollment
- 145
- Locations
- 9
- Primary Endpoint
- 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).
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
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.
Detailed Description
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 .
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient has given his/hers consent or the patient is in an emergency situation (commitment to obtain the consent of the patient as soon as his/her condition permits)
- •Patient affiliated or beneficiary of a health insurance plan
- •Patient with septic shock: proven or suspected infection associated with hypotension or lactate\> 4 mmol / l or organ dysfunction. Hypotension despite fluid resuscitation of 20 to -40 ml / kg.
- •Patient under controlled mechanical ventilation
- •Patient 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.
Exclusion Criteria
- •The patient is has in another interventional study that might change the results of this study within the past 3 months
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •The patient is pregnant, parturient, or breastfeeding
- •Valvular pathology: grade III and IV aortic or mitral insufficiency
- •Non sinus electrocardiogram
- •Non-echogenic patient
- •Patient with any spontaneous breathing
- •Moribund patient
Outcomes
Primary Outcomes
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).
Time Frame: 30 minutes
Secondary Outcomes
- Mitral E wave(30 minutes)
- Mitral A wave(30 minutes)
- E' Wave at the lateral mitral annulus(30 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)