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

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.

Study Overview

• Status: Completed
• Conditions: Septic Shock
• Intervention / Treatment: Procedure: Fluid challenge; Procedure: Cardiac ultrasound

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 Type: Observational
• Enrollment (Actual): 145

Contacts and Locations

Study Locations

• France
  • Amiens Cedex 1, France, 80054
    • CHU d'Amiens - Hôpital Nord
  • Besançon, France, 25030
    • CHU de Besançon - Hôpital Jean MINJOZ
  • Caen Cedex 9, France, 14033
    • CHU de Caen - Hôpital Côte de Nacre
  • Clermont Ferrand, France, 63003
    • CHU de Clermont Ferrand - Hopital Estaing
  • Clermont Ferrand, France, 63003
    • CHU de Clermont Ferrand - Hôpital Gabriel-Montpied
  • Marseille Cedex 20, France, 13915
    • Aphm - Hopital Nord
  • Nantes, France, 44093
    • CHU de Nantes - Hôpital Guillaume et René Laënnec
  • Nice Cedex 1, France, 06001
    • CHU de Nice - Hôpital St-Roch
  • Nîmes Cedex 09, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Procedure: Fluid challenge; The fluid challenge starts at minute 0 (T0) and consists of 500ml of crystalloids over 10 minutes.; Procedure: Cardiac ultrasound; Ultrasound measures are made at T0, T2, T4, T6, T8, T10, T20 and T30.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Time Frame
Mitral E wave	Baseline (minute 0)
Mitral E wave	2 minutes
Mitral E wave	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: April 15, 2014
• First Submitted That Met QC Criteria: April 15, 2014
• First Posted (Estimate): April 16, 2014

Study Record Updates

• Last Update Posted (Estimate): January 20, 2016
• Last Update Submitted That Met QC Criteria: January 18, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: fluid resuscitation; fluid challenge
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: LOCAL/2013/CR-01; 2013-A01702-43 (Other Identifier: RCB number)