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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 February 2016
• Main ID: NCT02116413
• Date of registration: 15/04/2014
• Prospective Registration: Yes
• Primary sponsor: Centre Hospitalier Universitaire de Nimes
• Public title: Does the Time Between the End of Vascular Filling and Evaluation of Its Effectiveness Modify Fluid Challenge Results in Septic Shock? FC-Rev
• Scientific title: Does the Time Between the End of Vascular Filling and Evaluation of Its Effectiveness Modify Fluid Challenge Results in Septic Shock?
• Date of first enrolment: May 2014
• Target sample size: 145
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02116413
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Claire Roger, MD
• Affiliation: Centre Hospitalier Universitaire de Nîmes

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Septic Shock

Intervention(s)

Procedure: Fluid challenge

Procedure: Cardiac ultrasound

Primary Outcome(s)

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). [Time Frame: 30 minutes]

Secondary Outcome(s)

E' Wave at the lateral mitral annulus [Time Frame: 30 minutes]

ITV [Time Frame: 10 minutes]

E' Wave at the lateral mitral annulus [Time Frame: 10 minutes]

E' Wave at the lateral mitral annulus [Time Frame: 2 minutes]

Mitral A wave [Time Frame: 20 minutes]

Mitral A wave [Time Frame: 4 minutes]

Mitral E wave [Time Frame: 2 minutes]

Mitral E wave [Time Frame: 8 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). [Time Frame: 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). [Time Frame: 20 minutes]

E' Wave at the lateral mitral annulus [Time Frame: 8 minutes]

Mitral A wave [Time Frame: 10 minutes]

ITV [Time Frame: 30 minutes]

Mitral A wave [Time Frame: 2 minutes]

Mitral A wave [Time Frame: 8 minutes]

Mitral E wave [Time Frame: 20 minutes]

Mitral E wave [Time Frame: 4 minutes]

Mitral E wave [Time Frame: Baseline (minute 0)]

E' Wave at the lateral mitral annulus [Time Frame: 20 minutes]

E' Wave at the lateral mitral annulus [Time Frame: 6 minutes]

ITV [Time Frame: Baseline (minute 0)]

Mitral E wave [Time Frame: 30 minutes]

ITV [Time Frame: 20 minutes]

Mitral A wave [Time Frame: 6 minutes]

Mitral A wave [Time Frame: 30 minutes]

Mitral E wave [Time Frame: 10 minutes]

Mitral E wave [Time Frame: 6 minutes]

E' Wave at the lateral mitral annulus [Time Frame: 4 minutes]

E' Wave at the lateral mitral annulus [Time Frame: Baseline (minute 0)]

Mitral A wave [Time Frame: Baseline (minute 0)]

Secondary ID(s)

2013-A01702-43

LOCAL/2013/CR-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors