Effects of Norepinephrine and Volume Expansion in Capillary Refill Time in Septic Shock

Septic Shock Clinical Trial

— NOVECAR  

Official title:

Effects of Norepinephrine and Volume Expansion in Capillary Refill Time in Septic Shock

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04870892
• Other study ID #: 2021-A00624-37
• Status: Recruiting
• Start date: January 15, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2021
• Source: Bicetre Hospital
• Contact: Xavier Monnet, MD-PhD
• Phone: +33-(0)6660862669
• Email: xavier.monnet[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess the effect of norepinephrine and fluid expansion on capillary refill time during septic shock.

Description:

An interventional study compared, in septic shock, the effect of resuscitation strategy targeting normalization of capillary refill time versus strategy targeting serum lactate level. This last highlight a decrease of organ dysfunction at 72 hours with capillary refill time strategy and non-significant trend towards lower 28-day mortality in the capillary refill time strategy group.

The strategy guided by the decreasing of capillary refill time allowed the administration of less fluid than that guided by lactate. This is an important advantage when the intensive care doctor know that the mortality of patient in septic shock increases with the amount of fluid administered.

However, the variations of capillary refill time induced by the principal treatment in septic shock (norepinephrine and fluid resuscitation) during circulatory failure are actually insufficiently described. The purpose of this study is to assess the effect of norepinephrine and fluid expansion on capillary refill time during septic shock.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Septic shock

• Presence of a cardiac output monitoring device with the PICCO2 system (Pulsion Medical Systems, Feldkirchen, Germany)

• Decision by the physician in charge to perform vascular filling or modification the norepinephrine dose

Exclusion Criteria:

• Pregnant

• Patient under a tutelage measure or placed under judicial protection

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Locations

Country	Name	City	State
France	Medical Intensive Care Unit	Le Kremlin-Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
Bicetre Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of capillary refill time before and after the therapeutic change	Capillary refill time is time required for return of color after application of blanching pressure to a distal capillary bed. In this study, we made a calibrated compression of the skin using a piston for seven seconds, and we recorded CRT with a smartphone's video camera.	Change from capillary refill time between the 15 min before the therapeutic, Immediately after fluid administration and within the 15 minutes of a change in norepinephrine dose
Secondary	Correlation between capillary refill time and perfusion index	Capillary refill time is time required for return of color after application of blanching pressure to a distal capillary bed. In this study, we made a calibrated compression of the skin using a piston for seven seconds, and we recorded CRT with a smartphone's video camera.	Change from capillary refill time between the 15 min before the therapeutic, Immediately after fluid administration and within the 15 minutes of a change in norepinephrine dose
Secondary	Least significant change of capillary refill time	Capillary refill time is time required for return of color after application of blanching pressure to a distal capillary bed. In this study, we made a calibrated compression of the skin using a piston for seven seconds, and we recorded CRT with a smartphone's video camera.	Change from capillary refill time between the 15 min before the therapeutic, Immediately after fluid administration and within the 15 minutes of a change in norepinephrine dose
Secondary	Difference between capillary refill time on thorax and on the index finger tip	Capillary refill time is time required for return of color after application of blanching pressure to a distal capillary bed. In this study, we made a calibrated compression of the skin using a piston for seven seconds, and we recorded CRT with a smartphone's video camera.	Change from capillary refill time between the 15 min before the therapeutic, Immediately after fluid administration and within the 15 minutes of a change in norepinephrine dose