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

NCT02116413 | Completed

• 2 other identifiers: LOCAL/2013/CR-012013-A01702-43
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 9

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.

Conditions

Septic Shock

Keywords

fluid challenge; fluid resuscitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (30)

• 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

Study Arms (1)

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; Procedure: Cardiac ultrasound

Interventions

Fluid challenge PROCEDURE

The fluid challenge starts at minute 0 (T0) and consists of 500ml of crystalloids over 10 minutes.

The study population

Cardiac ultrasound PROCEDURE

Ultrasound measures are made at T0, T2, T4, T6, T8, T10, T20 and T30.

The study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (9)

CHU d'Amiens - Hôpital Nord

Amiens, 80054, France

Location

CHU de Besançon - Hôpital Jean Minjoz

Besançon, 25030, France

Location

CHU de Caen - Hôpital Côte de Nacre

Caen, 14033, France

Location

CHU de Clermont Ferrand - Hôpital Estaing

Clermont-Ferrand, 63003, France

Location

CHU de Clermont Ferrand - Hôpital Gabriel-Montpied

Clermont-Ferrand, 63003, France

Location

APHM - Hôpital Nord

Marseille, 13915, France

Location

CHU de Nantes - Hôpital Guillaume et René Laennec

Nantes, 44093, France

Location

CHU de Nice - Hôpital St-Roch

Nice, 06001, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Related Publications (1)

• 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.

  PMID: 31097012 RESULT

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Claire Roger, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 16, 2014
• Study Start: May 1, 2014
• Primary Completion: January 8, 2016
• Study Completion: January 8, 2016
• Last Updated: November 19, 2025

Record last verified: 2016-01

Locations

FR (9)