Does the Time Between the End of Vascular Filling and Evaluation of Its Effectiveness Modify Fluid Challenge Results in Septic Shock?

Completed

• Conditions: Septic Shock

• Registration Number: NCT02116413
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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 .

Study Timeline

• Study First Submitted: 2014-04-15
• Study First Submitted QC: 2014-04-15
• Study First Posted: 2014-04-16
• Study Start: 2014-05
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-18
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

CHU d'Amiens - Hôpital Nord; 🇫🇷 Amiens Cedex 1, France

CHU de Besançon - Hôpital Jean Minjoz; 🇫🇷 Besançon, France

CHU de Caen - Hôpital Côte de Nacre; 🇫🇷 Caen Cedex 9, France

CHU de Clermont Ferrand - Hôpital Estaing; 🇫🇷 Clermont Ferrand, France

CHU de Clermont Ferrand - Hôpital Gabriel-Montpied; 🇫🇷 Clermont Ferrand, France

APHM - Hôpital Nord; 🇫🇷 Marseille Cedex 20, France

CHU de Nantes - Hôpital Guillaume et René Laennec; 🇫🇷 Nantes, France

CHU de Nice - Hôpital St-Roch; 🇫🇷 Nice Cedex 1, France

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France