Peripheral Tissue Perfusion in Intensive Care (INPPEREA)

Effects of Therapeutic Hemodynamic Interventions on Peripheral Perfusion in Intensive Care

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).

Study Overview

• Status: Recruiting
• Conditions: Acute Circulatory Failure

Detailed Description

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).

• Study Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: Hafid Ait-Oufella; Phone Number: +33612011940; Email: hafid.aitoufella@aphp.fr

Study Locations

• France
  • Paris, France, 75012
    • Recruiting
    • Saint -Antoine Hospital_Médecine Intensive Reanimation
    • Contact: Hafid Ait-Oufella; Phone Number: +33612011940; Email: hafid.aitoufella@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin blood flow variations	Measurement using laser doppler probe in the finger tip	continuous monitoring during 1 hour maximum starting just before intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Capillary refill time	Clinical measurement at bedside	at baseline, 3 timepoints after starting interventions (10, 30 and 60 minutes)
Mottling score	Clinical measurement at bedside	at baseline, 3 timepoints after starting interventions (10, 30 and 60 minutes)
correlation between Skin blood flow and CRT (baseline and variations)	Measurement using laser doppler probe in the finger tip	at baseline, at 10, 30 and 60 minutes after intervention
correlation between skin blood flow and Cardiac output	Laser doppler with skin probe and echocardiography	at baseline, at 10, 30 and 60 minutes after intervention
correlation between skin blood flow and mean arterial pressure	Laser doppler with skin probe and arterial catheter	at baseline, at 10, 30 and 60 minutes after intervention

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Skin blood flow; Capillary refill time; Fluid challenge; Inotrope; Tissue perfusion
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock
• Other Study ID Numbers: APHP231342

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No