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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04870892
Acronym
NOVECAR
Enrollment
64
Registered
2021-05-04
Start date
2021-01-15
Completion date
2022-12-31
Last updated
2021-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Keywords

septic shock, capillary refill time, norepinephrine, fluid infusion

Brief summary

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

Interventions

None listed

Sponsors

Bicetre Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Difference of capillary refill time before and after the therapeutic changeChange 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 doseCapillary 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.

Secondary

MeasureTime frameDescription
Correlation between capillary refill time and perfusion indexChange 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 doseCapillary 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.
Least significant change of capillary refill timeChange 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 doseCapillary 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.
Difference between capillary refill time on thorax and on the index finger tipChange 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 doseCapillary 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.

Countries

France

Contacts

Primary ContactXavier Monnet, MD-PhD
xavier.monnet@aphp.fr+33-(0)6660862669
Backup ContactNicolas Fage, MSC
fage.nicolas@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026