Peripheral Tissue Perfusion in Intensive Care

NCT ID: NCT06384287

Last Updated: 2025-09-02

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

RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-22

Study Completion Date

2027-07-31

Brief Summary

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Tissue perfusion has been identified as an early prognosis factor in patients admitted to intensive care. However, little is known about the effects of different hemodynamic interventions performed in clinical routine on peripheral tissue perfusion.

The aim of this work is to study the kinetics of CRT and local skin blood flow following therapeutic intervention (fluid challenge, vasopressor or inotropic drug).

Detailed Description

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Sepsis is today a major cause of morbidity and mortality worldwide. Septic shock, the most serious manifestation of the infection, affects 2 to 20% of intensive care patients. Despite appropriate antibiotic therapy and improved resuscitation strategies based on early treatment, volume expansion and rational use of vasopressors, the mortality rate of shock states remains too high, between 40 and 50%.

Over the past two decades, great advances have been made in the understanding the pathophysiology of septic shock. Microcirculatory abnormalities have been identified as the main cause of organ hypoperfusion and visceral failure leading to death. In addition, several studies in animals and humans have highlighted a discordance between systemic hemodynamic parameters and alterations of small vessels during shock suggesting that microvascular blood flow and tissue perfusion should be analyzed in patients with acute circulatory failure in association with blood pressure and cardiac output. Capillary refill time (CRT), is an easy-to-use, easy-to learn tool to evaluate peripheral tissue perfusion. CRT is a strong predictive factor of organ failure severity and poor outcome in critically ill patients with sepsis. A recent randomized trial reported promising results regarding the use of CRT to guide resuscitation. However, little is known about the impact of treatment on CRT. The aim of this work is to study the kinetics of CRT and local skin blood flow following therapeutic intervention (fluid challenge, vasopressor or inotropic drug).

Conditions

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Acute Circulatory Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fluid challenge

Impact of fluid challenge on peripheral tissue perfusion on sepsis patients

No interventions assigned to this group

Vasopressors

Impact of vasopressors on peripheral tissue perfusion on sepsis patients

No interventions assigned to this group

Inotrope

Impact of dobutamine on peripheral tissue perfusion on patients with septic or cardiogenic shock

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients in intensive care unit with acute circulatory failure related to sepsis or cardiac failure requiring therapeutic intervention

Exclusion Criteria

* Agitation
* Hemorrhagic shock
* Severe skin lesions
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Saint -Antoine Hospital_Médecine Intensive Reanimation

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Hafid Ait-Oufella

Role: CONTACT

+33612011940

Facility Contacts

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Hafid Ait-Oufella

Role: primary

+33612011940

Other Identifiers

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APHP231342

Identifier Type: -

Identifier Source: org_study_id

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