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

NCT ID: NCT04870892

Last Updated: 2021-05-04

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

UNKNOWN

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-15

Study Completion Date

2022-12-31

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 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 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 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bicetre Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xavier Monnet

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xavier Monnet, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Service de Médecine Intensive - Réanimation, Hôpital Bicêtre, AP-HP

Locations

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Medical Intensive Care Unit

Le Kremlin-Bicêtre, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Xavier Monnet, MD-PhD

Role: CONTACT

+33-(0)6660862669

Nicolas Fage, MSC

Role: CONTACT

Facility Contacts

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Xavier Monnet, MD, PhD

Role: primary

References

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Fage N, Moretto F, Rosalba D, Shi R, Lai C, Teboul JL, Monnet X. Effect on capillary refill time of volume expansion and increase of the norepinephrine dose in patients with septic shock. Crit Care. 2023 Nov 6;27(1):429. doi: 10.1186/s13054-023-04714-0.

Reference Type DERIVED
PMID: 37932812 (View on PubMed)

Other Identifiers

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2021-A00624-37

Identifier Type: -

Identifier Source: org_study_id

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