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
• Interventions: Procedure: Fluid challenge; Procedure: Cardiac ultrasound

• 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

Arm && Interventions

Group	Intervention	Description
The study population	Fluid challenge	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
The study population	Cardiac ultrasound	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

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

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

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

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

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

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

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

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

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