Clinical trial NCT06384287: Peripheral Tissue Perfusion in Intensive Care
Official title: Effects of Therapeutic Hemodynamic Interventions on Peripheral Perfusion in Intensive Care
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Circulatory Failure
Keywords: Tissue perfusion
Capillary refill time
Skin blood flow
Fluid challenge
Inotrope
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: Skin blood flow variations
timeFrame: continuous monitoring during 1 hour maximum starting just before intervention
Secondary outcomes:
measure: Capillary refill time
timeFrame: at baseline, 3 timepoints after starting interventions (10, 30 and 60 minutes)
measure: Mottling score
timeFrame: at baseline, 3 timepoints after starting interventions (10, 30 and 60 minutes)
measure: correlation between Skin blood flow and CRT (baseline and variations)
timeFrame: at baseline, at 10, 30 and 60 minutes after intervention
measure: correlation between skin blood flow and Cardiac output
timeFrame: at baseline, at 10, 30 and 60 minutes after intervention
measure: correlation between skin blood flow and mean arterial pressure
timeFrame: at baseline, at 10, 30 and 60 minutes after intervention
Other outcomes:
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