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Recruiting NCT06384287

Peripheral Tissue Perfusion in Intensive Care

Observational Acute Circulatory Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acute Circulatory Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Therapeutic Hemodynamic Interventions on Peripheral Perfusion in Intensive Care

Overview

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).

Primary outcome measures

  • Skin blood flow variations [Time frame: continuous monitoring during 1 hour maximum starting just before intervention]
Secondary outcome measures (5)
  • Capillary refill time [Time frame: at baseline, 3 timepoints after starting interventions (10, 30 and 60 minutes)]
  • Mottling score [Time frame: at baseline, 3 timepoints after starting interventions (10, 30 and 60 minutes)]
  • correlation between Skin blood flow and CRT (baseline and variations) [Time frame: at baseline, at 10, 30 and 60 minutes after intervention]
  • correlation between skin blood flow and Cardiac output [Time frame: at baseline, at 10, 30 and 60 minutes after intervention]
  • correlation between skin blood flow and mean arterial pressure [Time frame: at baseline, at 10, 30 and 60 minutes after intervention]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Saint -Antoine Hospital_Médecine Intensive Reanimation — Paris

Identifiers

NCT: NCT06384287 · APHP231342

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗