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

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ClinicalTrials.gov Identifier: NCT04870892

Recruitment Status : Recruiting

First Posted : May 4, 2021

Last Update Posted : May 4, 2021

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Xavier Monnet, Bicetre Hospital

Study Description

Brief Summary:

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

Condition or disease
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 Design

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Study Type :	Observational
Estimated Enrollment :	64 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Effects of Norepinephrine and Volume Expansion in Capillary Refill Time in Septic Shock
Actual Study Start Date :	January 15, 2021
Estimated Primary Completion Date :	December 31, 2022
Estimated Study Completion Date :	December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Drug Information available for: Norepinephrine

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

Difference of capillary refill time before and after the therapeutic change [ Time Frame: 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 ]
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.

Secondary Outcome Measures :

Correlation between capillary refill time and perfusion index [ Time Frame: 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 ]
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.
Least significant change of capillary refill time [ Time Frame: 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 ]
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.
Difference between capillary refill time on thorax and on the index finger tip [ Time Frame: 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 ]
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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04870892

Contacts

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Contact: Xavier Monnet, MD-PhD	+33-(0)6660862669	xavier.monnet@aphp.fr
Contact: Nicolas Fage, MSC		fage.nicolas@gmail.com

Locations

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France
Medical Intensive Care Unit	Recruiting
Le Kremlin-Bicêtre, France
Contact: Xavier Monnet, MD, PhD
Principal Investigator: Xavier Monnet, MD, PhD

Sponsors and Collaborators

Bicetre Hospital

Investigators

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Principal Investigator:	Xavier Monnet, MD-PhD	Service de Médecine Intensive - Réanimation, Hôpital Bicêtre, AP-HP

More Information

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Responsible Party:	Xavier Monnet, Clinical Professor, Bicetre Hospital
ClinicalTrials.gov Identifier:	NCT04870892
Other Study ID Numbers:	2021-A00624-37
First Posted:	May 4, 2021 Key Record Dates
Last Update Posted:	May 4, 2021
Last Verified:	April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Xavier Monnet, Bicetre Hospital:


septic shock capillary refill time norepinephrine fluid infusion

Additional relevant MeSH terms:

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Shock, Septic Shock Pathologic Processes Sepsis	Infections Systemic Inflammatory Response Syndrome Inflammation

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