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

Septic Shock Clinical Trial

— FC-Rev  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02116413
• Other study ID #: LOCAL/2013/CR-01
• Secondary ID: 2013-A01702-43
• Status: Completed
• Phase: N/A
• First received: April 15, 2014
• Last updated: January 18, 2016
• Start date: May 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

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

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mitral E wave		Baseline (minute 0)	No
Secondary	Mitral E wave		2 minutes	No
Secondary	Mitral E wave		4 minutes	No
Secondary	Mitral E wave		6 minutes	No
Secondary	Mitral E wave		8 minutes	No
Secondary	Mitral E wave		10 minutes	No
Secondary	Mitral E wave		20 minutes	No
Secondary	Mitral E wave		30 minutes	No
Secondary	Mitral A wave		Baseline (minute 0)	No
Secondary	Mitral A wave		2 minutes	No
Secondary	Mitral A wave		4 minutes	No
Secondary	Mitral A wave		6 minutes	No
Secondary	Mitral A wave		8 minutes	No
Secondary	Mitral A wave		10 minutes	No
Secondary	Mitral A wave		20 minutes	No
Secondary	Mitral A wave		30 minutes	No
Secondary	E' Wave at the lateral mitral annulus		Baseline (minute 0)	No
Secondary	E' Wave at the lateral mitral annulus		2 minutes	No
Secondary	E' Wave at the lateral mitral annulus		4 minutes	No
Secondary	E' Wave at the lateral mitral annulus		6 minutes	No
Secondary	E' Wave at the lateral mitral annulus		8 minutes	No
Secondary	E' Wave at the lateral mitral annulus		10 minutes	No
Secondary	E' Wave at the lateral mitral annulus		20 minutes	No
Secondary	E' Wave at the lateral mitral annulus		30 minutes	No
Secondary	ITV		Baseline (minute 0)	No
Secondary	ITV		10 minutes	No
Secondary	ITV		20 minutes	No
Secondary	ITV		30 minutes	No
Secondary	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	No
Secondary	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	No