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

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

Study Overview

• Status: Recruiting
• Conditions: Septic Shock

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 64

Contacts and Locations

• Study Contact: Name: Xavier Monnet, MD-PhD; Phone Number: +33-(0)6660862669; Email: xavier.monnet@aphp.fr
• Study Contact Backup: Name: Nicolas Fage, MSC; Email: fage.nicolas@gmail.com

Study Locations

• France
  • Le Kremlin-Bicêtre, France
    • Recruiting
    • Medical Intensive Care Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with septic shock, cardiac output monitoring device with the PICCO2 system

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Norepinephrine variation; Patients with septic shock, cardiac output monitoring device with the PICCO2 system and decision by the physician in charge to modify the norepinephrine dose.
Fluid infusion; Patients with septic shock, cardiac output monitoring device with the PICCO2 system and decision by the physician in charge to give fluid infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Bicetre Hospital
• Investigators: Principal Investigator: Xavier Monnet, MD-PhD, Service de Médecine Intensive - Réanimation, Hôpital Bicêtre, AP-HP

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2021
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (ACTUAL): May 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: septic shock; norepinephrine; fluid infusion; capillary refill time
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: 2021-A00624-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No