NCT06384287

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
14mo left

Started Jun 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Jun 2024Jul 2027

First Submitted

Initial submission to the registry

April 3, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 25, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 22, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

3 years

First QC Date

April 3, 2024

Last Update Submit

August 25, 2025

Conditions

Acute Circulatory Failure

Keywords

Tissue perfusionCapillary refill timeSkin blood flowFluid challengeInotrope

Outcome Measures

Primary Outcomes (1)

  • Skin blood flow variations

    Measurement using laser doppler probe in the finger tip

    continuous monitoring during 1 hour maximum starting just before intervention

Secondary Outcomes (5)

  • Capillary refill time

    at baseline, 3 timepoints after starting interventions (10, 30 and 60 minutes)

  • Mottling score

    at baseline, 3 timepoints after starting interventions (10, 30 and 60 minutes)

  • correlation between Skin blood flow and CRT (baseline and variations)

    at baseline, at 10, 30 and 60 minutes after intervention

  • correlation between skin blood flow and Cardiac output

    at baseline, at 10, 30 and 60 minutes after intervention

  • correlation between skin blood flow and mean arterial pressure

    at baseline, at 10, 30 and 60 minutes after intervention

Study Arms (3)

Fluid challenge

Impact of fluid challenge on peripheral tissue perfusion on sepsis patients

Vasopressors

Impact of vasopressors on peripheral tissue perfusion on sepsis patients

Inotrope

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in intensive care unit with acute circulatory failure related to sepsis or cardiac failure requiring a therapeutic intervention (fluid challenge or vasopressor or dobutamine)

You may qualify if:

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

You may not qualify if:

  • Agitation
  • Hemorrhagic shock
  • Severe skin lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint -Antoine Hospital_Médecine Intensive Reanimation

Paris, 75012, France

RECRUITING

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Hafid Ait-Oufella

CONTACT

+33612011940hafid.aitoufella@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2024

First Posted

April 25, 2024

Study Start

June 22, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

September 2, 2025

Record last verified: 2025-08

Locations

FR(1)