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Completed

NCT Number: NCT02116413

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'Amiens - Hôpital Nord, Amiens, France

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About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluid challenge

Procedure

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

Cardiac ultrasound

Procedure

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

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).

    Time frame: 30 minutes

Secondary outcomes

  1. Mitral E wave

    Time frame: Baseline (minute 0)

  2. Mitral E wave

    Time frame: 2 minutes

  3. Mitral E wave

    Time frame: 4 minutes

  4. Mitral E wave

    Time frame: 6 minutes

  5. Mitral E wave

    Time frame: 8 minutes

  6. Mitral E wave

    Time frame: 10 minutes

  7. Mitral E wave

    Time frame: 20 minutes

  8. Mitral E wave

    Time frame: 30 minutes

  9. Mitral A wave

    Time frame: Baseline (minute 0)

  10. Mitral A wave

    Time frame: 2 minutes

  11. Mitral A wave

    Time frame: 4 minutes

  12. Mitral A wave

    Time frame: 6 minutes

  13. Mitral A wave

    Time frame: 8 minutes

  14. Mitral A wave

    Time frame: 10 minutes

  15. Mitral A wave

    Time frame: 20 minutes

  16. Mitral A wave

    Time frame: 30 minutes

  17. E' Wave at the lateral mitral annulus

    Time frame: Baseline (minute 0)

  18. E' Wave at the lateral mitral annulus

    Time frame: 2 minutes

  19. E' Wave at the lateral mitral annulus

    Time frame: 4 minutes

  20. E' Wave at the lateral mitral annulus

    Time frame: 6 minutes

  21. E' Wave at the lateral mitral annulus

    Time frame: 8 minutes

  22. E' Wave at the lateral mitral annulus

    Time frame: 10 minutes

  23. E' Wave at the lateral mitral annulus

    Time frame: 20 minutes

  24. E' Wave at the lateral mitral annulus

    Time frame: 30 minutes

  25. ITV

    Time frame: Baseline (minute 0)

  26. ITV

    Time frame: 10 minutes

  27. ITV

    Time frame: 20 minutes

  28. ITV

    Time frame: 30 minutes

  29. 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

  30. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: FC-Rev

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 16, 2014
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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