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Clinical Trials/NCT06384287
NCT06384287RecruitingNot Applicable

Effects of Therapeutic Hemodynamic Interventions on Peripheral Perfusion in Intensive Care

Assistance Publique - Hôpitaux de Paris1 site in 1 country180 target enrollmentStarted: June 22, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
180
Locations
1
Primary Endpoint
Skin blood flow variations

Study Overview

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).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • Mottling score(at baseline, 3 timepoints after starting interventions (10, 30 and 60 minutes))
  • correlation between skin blood flow and Cardiac output(at baseline, at 10, 30 and 60 minutes after intervention)
  • Capillary refill time(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 mean arterial pressure(at baseline, at 10, 30 and 60 minutes after intervention)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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