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

NCT ID: NCT05325957

Last Updated: 2024-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-31

Study Completion Date

2024-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Septic Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Norepinephrine variation

Patients with septic shock, cardiac output monitoring device with the PICCO2 system or swan ganz catheter and decision by the physician in charge to modify the norepinephrine dose.

No interventions assigned to this group

Fluid infusion

Patients with septic shock, cardiac output monitoring device with the PICCO2 system or swan ganz catheter and decision by the physician in charge to give fluid infusion

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Septic shock
* Presence of a cardiac output monitoring
* Decision by the physician in charge to perform vascular filling or modification the norepinephrine dose

Exclusion Criteria

* Patient under a tutelage measure or placed under judicial protection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre ASFAR, M.D- Ph.D

Role: PRINCIPAL_INVESTIGATOR

Angers CHU

Locations

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Medical Intensive Care Unit

Angers, Maine-et-Loire, France

Site Status

Countries

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France

Other Identifiers

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49RC22_0096

Identifier Type: -

Identifier Source: org_study_id

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