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NCT Number: NCT06384287

Peripheral Tissue 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Saint -Antoine Hospital_Médecine Intensive Reanimation

Paris, 75012, France

Location status: Recruiting

Location contact

Hafid Ait-Oufella

CONTACT

[email protected]

+33612011940

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Skin blood flow variations

    Time frame: continuous monitoring during 1 hour maximum starting just before intervention

    Measurement using laser doppler probe in the finger tip

Secondary outcomes

  1. Capillary refill time

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

    Clinical measurement at bedside

  2. Mottling score

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

    Clinical measurement at bedside

  3. correlation between Skin blood flow and CRT (baseline and variations)

    Time frame: at baseline, at 10, 30 and 60 minutes after intervention

    Measurement using laser doppler probe in the finger tip

  4. correlation between skin blood flow and Cardiac output

    Time frame: at baseline, at 10, 30 and 60 minutes after intervention

    Laser doppler with skin probe and echocardiography

  5. correlation between skin blood flow and mean arterial pressure

    Time frame: at baseline, at 10, 30 and 60 minutes after intervention

    Laser doppler with skin probe and arterial catheter

Study contacts

Contact information is provided by the study sponsor or research team.

Hafid Ait-Oufella

CONTACT

[email protected]

+33612011940

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Effects of Therapeutic Hemodynamic Interventions on Peripheral Perfusion in Intensive Care

Acronym: INPPEREA

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 25, 2024
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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