NCT02116413

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 145 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 .

Conditions

• Septic Shock

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-01-08
• Completion: 2016-01-08
• First posted: 2014-04-16
• Last updated: 2025-11-19

Locations

9 sites across 1 country: France