Peripheral Tissue Perfusion in Intensive Care

Acute Circulatory Failure Clinical Trial

— INPPEREA  

Official title:

Effects of Therapeutic Hemodynamic Interventions on Peripheral Perfusion in Intensive Care

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06384287
• Other study ID #: APHP231342
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: May 2027

Study information

• Verified date: April 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Hafid Ait-Oufella
• Phone: +33612011940
• Email: hafid.aitoufella[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: May 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Circulatory Failure
• Shock

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin blood flow variations	Measurement using laser doppler probe in the finger tip	continuous monitoring during 1 hour maximum starting just before intervention
Secondary	Capillary refill time	Clinical measurement at bedside	at baseline, 3 timepoints after starting interventions (10, 30 and 60 minutes)
Secondary	Mottling score	Clinical measurement at bedside	at baseline, 3 timepoints after starting interventions (10, 30 and 60 minutes)
Secondary	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
Secondary	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
Secondary	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